International Journal of Paediatric Dentistry

2006

16

199ndash206

copy 2006 BSPD and IAPD

199

Blackwell Publishing Ltd

Is there life after Buckleyrsquos formocresol Part II ndash Development of a protocol for the management of extensive caries in the primary molar

C L PATCHETT

1

V SRINIVASAN

1

amp P J WATERHOUSE

2

1

Department of Child Dental Health Newcastle Dental Hospital and

2

School of Dental Sciences University of Newcastle

upon Tyne Newcastle upon Tyne UK

Summary

Objective

To produce a working clinical protocol for pulp therapy techniques in the extensively cariousprimary molar

Introduction

The International Agency for Research on Cancer has recently classified formaldehyde as carcinogenic tohuman beings As such a medicament that can be used to replace formocresol in clinical practice should be identified

Methods

Part I of this paper explored the currently available alternative interventions and materials to formocresol inthe form of a narrative review following an extensive literature search Part II now presents the formation of a specialistgroup to establish an evidence-based protocol for the management of the extensively carious primary molar

Conclusion

A protocol and key points document have been developed to assist clinicians in their treatment planning Areasfor further postgraduate training are identified

Introduction

Buckleyrsquos formocresol was first introduced as a pulpmedicament in 1904 [1] and since 1930 [2] it hasbeen the treatment of choice for primary molar vitalpulpotomies There is much published work relatingto its clinical use with clinical success ranging from55 to 98 [3ndash8] Several studies in the 1970sdemonstrated that a one-fifth dilution of formocresolwas as effective as a full-strength solution in termsof its initial cytotoxicity to fibroblasts [9ndash12]Concern over the use of formaldehyde has beenvoiced for some time [13 cited in 17 14ndash17] butuntil recently the evidence has been equivocal

Animal studies

Formaldehyde has been shown to be mutagenic in

Escherichia coli

bacteria [1819] and the fruit flyDrosophila [20] When administered in drinkingwater formaldehyde produced an increase in total

malignant tumours in rats [21] and when inhaledit has been shown to induce squamous cell carcinomaof the nasal cavity [22] Long-term studies usingrabbits have demonstrated that prolonged contactwith formaldehyde may produce precancerous andcancerous states in the epithelium [23] Otherauthors have suggested caution in extrapolatingthe findings of animal studies to human beings Inparticular the rat has been shown to be more suscept-ible to changes induced by inhaled formaldehyde[24]

Human

in vitro

studies

Mammalian cell

in vitro

studies have demonstratedunscheduled DNA synthesis in HeLa cells as a resultof formaldehyde application [25] and increased cellproliferation in respiratory mucosa [22] Forwardmutations have also been produced by formaldehydein a human lymphoblastoid cell line [26] Experimentalevidence has suggested that inhaled formaldehydevapour can exert toxic effects at remote sites as wellas in the respiratory tract Chromosomal aberrations[2728] increased micronuclei [272930] DNAndashprotein cross-links [3132] and sister chromatid

Correspondence C L Patchett Department of Child DentalHealth Newcastle Dental Hospital Richardson Road Newcastleupon Tyne NE2 4AZ UK E-mail clpatchettnclacuk

200

C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

exchanges [2732ndash34] have been found in peripherallymphocytes of humans exposed to formaldehydeAlthough there is an established link between chro-mosomal aberrations and cancer [35] the relation-ships between micronuclei or sister chromatid exchangesand health risks are less clear [36]

Human cohort studies

Long-term cohort studies of industrial workershave found increased risks for leukaemia particu-larly myeloid leukaemia in medical workers andother professionals exposed to formaldehyde [3738]whilst other research does not support these findings[39] Possible associations have also been suggestedbetween occupational formaldehyde and cancer ofthe lung [3940] nasopharynx [3941] stomach[39] paranasal sinuses [4243] prostate [4144]brain [44] and pancreas [45] However theseassociations remain inconsistent

Dental studies

Systemic distribution of radio-isotope-labelledformaldehyde has been demonstrated followingformocresol pulpotomy in dogs [46] and rhesusmonkeys [47] Labelled formaldehyde has been foundin periodontal ligament bone dentine and urine andsmaller amounts in the liver kidney lungs skeletalmuscle and cerebrospinal fluid within minutes of thepulpotomy [46] More recently a human case controlstudy demonstrated a single case of mutagenicity inperipheral blood lymphocyte cultures followingformocresol pulpotomy [48] A correlation betweenformocresol pulpotomies in primary teeth and enameldefects in the permanent successor has been sug-gested [49] although other workers found no suchlinks [50]

In June 2004 the International Agency forResearch on Cancer (IARC) classified formaldehydeas carcinogenic to human beings [51] The expertworking group determined that there is now sufficientevidence that formaldehyde causes nasopharyngealcancer in humans limited evidence for cancer of thenasal cavity and paranasal sinuses and strong butnot sufficient evidence for a causal association betweenleukaemia and occupational exposure to formaldehydeThe IARC working group recommended furtherresearch in order to identify a mechanism for theinduction of leukaemia and to build on the existingevidence base

Care pathways clinical protocols and decision trees

The National Pathway Association was founded in1994 to support the development of integrated carepathways A care pathway determines locallyagreed multidisciplinary practice based on guide-lines and evidence where available for a specificpatient group It forms all or part of the clinicalrecord documents the care given and facilitates theevaluation of outcomes for continuous qualityimprovement [52]

A clinical protocol is a written framework for theexpected management path and outcome for apatient undergoing a particular procedure Clinicalprotocols and care pathways are being widely imple-mented in the National Health Service (NHS) andalthough concerns were initially expressed regardingthe lack of evidence for their efficacy [5354] recentwork has helped to address this issue It wouldappear that both are capable of improving qualityof care and patient satisfaction [55] The aim of aclinical protocol is to improve the quality of careand ensure that treatment is based on the latestevidence and research They should complementrather than abolish intuitive thought based on clinicalexpertise Education and training strategies areessential to support understanding ownership andacceptance [56]

Decision analysis is the application of structuredquantitative methods to analyse decisions underconditions of uncertainty [57] They can be showngraphically as decision trees and help to structureproblems and highlight areas for further researchDecision analysis works on the principle that thedegree of uncertainty decreases when the medicalliterature includes directly relevant and valid evidence[58]

Materials and methods

Protocol development

On 15 June 2004 the IARC issued a press releaseclassifying formaldehyde as carcinogenic to humanbeings [51] This information was circulated to allconsultants in paediatric dentistry and resulted in thewithdrawal of Buckleyrsquos formocresol and all para-formaldehyde-containing devitalising pastes fromthe majority of teaching hospitals In the Departmentof Child Dental Health Newcastle Dental HospitalNewcastle upon Tyne UK a specialist group of

Development of a pulp therapy protocol

201

copy 2006 BSPD and IAPD

paediatric dentists comprising consultants specialistregistrars university academics and a staff grade wasformed in order to establish a consensus decision on themanagement of extensively carious primary molar teeth

A traditional narrative literature review was com-pleted (Part I of this publication) and primaryresearch papers for each of the possible alternativesto formocresol were identified Where possible ran-domised control trials were chosen to evaluate clinicaland radiographic success for each medicament [59ndash65] Histological animal studies were identified toenable comparison between the cytological andtoxicological effects of different medicaments andtechniques [6667] Each clinician in the specialistgroup was asked to critically appraise their allocatedpapers and to present their findings at a lsquobrainstormingrsquosession

Following appraisal of the selected publicationsthe group discussed the ideal properties of a pulptherapy agent and tabulated the key findings of thereview (Table 1) It was felt that in light of therecent IARC findings it was necessary to implementthe chosen alternatives as soon as possible whilstalso considering techniques which may be possiblein the future

For inclusion in the protocol it was necessary fora technique or medicament to have a sufficientevidence base ideally human trials for clinical efficacyand to be economical in order to justify its routineuse within an NHS teaching hospital There shouldalso be little immediate financial outlay or trainingimplications to allow rapid introduction of theprotocol

On this basis ferric sulphate (AstringedentUltradent Products Inc South Jordan UT USA)was chosen for use in the vital primary molar pulpot-omy Although concerns were expressed that thisagent may mask underlying pulp pathosis it was feltthat it was clinically successful operator- and patient-friendly and a financially viable medicament Mineraltrioxide aggregate (MTA Pro Root Dentsply TulsaDental Weybridge UK) will also be an option for staff-performed pulpotomies and perhaps introduced intothe undergraduate arena in the future

A working draft of the protocol was produced andcirculated to enter into the lsquoiterativersquo process ofreview The draft protocol consisted of a flow chart toassist clinicians in their treatment planning combinedwith a key points document to offer further infor-mation and to standardise data for future research

Table 1 Comparison of alternatives to formocresol for pulp therapy (MTA) mineral trioxide aggregate (IPT) indirect pulp therapyand (BMP) bone morphogenic protein

MaterialClinical success(example cited)

Human clinical studies

Tested against

formocresol

Operator ease of

usePatient

acceptabilityCost of

techniqueEffect upon

pulp cell

Glutaraldehyde 82 over 25 months Yes Yes Good Good Low DevitalisationFuks et al [73]

Electrosurgery 99middot4 over 70 months No No Poor Poor Medium DevitalisationMack and Dean [74]

Ferric sulphate 92 over 4 years Yes Yes Good Good Low PreservationIbrecevic [60]

Calcium hydroxide 77middot1 over 22middot5 months Yes Yes Good Good Low PreservationWaterhouse [50]

MTA 100 over one year (grey) Yes No Fair Good High Preservation84middot2 over one year (white)Agamy et al [75]

Lasers 100 over 90 days Yes Yes Poor Poor High PreservationElliot et al [76]

IPT 95 over 2ndash72 weeks Yes Yes Good Good Low RemineralisationAl Zayer et al [77]

BMP No studies No No Unknown Unknown Unknown Remineralisation

Collagen No studies No No Unknown Unknown Unknown Remineralisation

Pulpectomy 91 over 36 months Yes Yes Poor Poor Low ExtirpationCasas and Kenny [61]

Ledermix 79 over 42 month Yes No Good Good Low PreservationHansen et al [78]

202

C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

and audit Each draft version was then circulated forcomment a further three times This resulted in theworking protocol (Fig 1) To facilitate future auditof the protocol every time pulp therapy is per-formed within the Department a stamp will beused to record standardised information in thepatientrsquos notes for example the time taken toachieve haemostasis and the number of applicationsof ferric sulphate required The information will alsobe recorded in a lsquopulp therapy bookrsquo

Implementation of the protocol

Undergraduate dental students were informed ofchanges in protocol via information uploaded withinthe University Virtual Learning Environment Inaddition a lecture was given to all third-year studentsprior to their initial clinical sessions within paedi-atric dentistry and an existing seminar was revisedto include an update on pulp therapy in the primarydentition The same information was supplied to allteachers of paediatric dentistry within the school andin outreach clinics It is expected that further modifi-cations to the teaching programme will be made aspulp therapy techniques are developed and audited

The working protocol and key points documentwere circulated to all staff working within thedepartment Discussion of these documents wasincorporated into the junior staff induction programmeNursing staff were also informed of the new techniquesand proposed local protocols via the senior nurseAreas for future staff training were identified at theteam meeting and hands-on training for specialiststaff has been arranged for the near future

Discussion

Following the recent IARC press release [51] theuse of formocresol in paediatric dentistry is nolonger recommended and clinicians must adoptalternative evidence-based procedures The authorsacknowledge that the evidence for some of thealternatives to formocresol is weak However theIARC statement demands a change to currentpractice and an urgent review of the alternatives inorder to develop an interim protocol It is hoped thatthis protocol will add to the debate and enable thecollection of standardised data which will in turnlead to a more evidence-based guideline in the future

The importance of careful patient and tooth selectionwhen considering provision of a pulp therapy cannot

be overemphasised In order for vital pulp therapyto be successful the patient must be sufficientlycompliant to allow adequate moisture control ideallywith rubber dam placement and the tooth must beradiographically free of pathology and restorablewith a bonded restoration or preformed metal crownin order to provide an effective seal

Despite careful initial assessment diagnosis ofpulpal status may be difficult For example once anirreversibly inflamed coronal pulp has been ampu-tated the health of the radicular pulp is assessed onan empirical basis ie how readily the pulp stumpbleeds As yet we have no scientific clinical methodof determining pulpal status prior to treatmentalthough there has been some work to investigatecorrelations between the presence of certain inflam-matory mediators and clinical outcome [6869]

Presently in Newcastle the treatment of choicefor nonvital primary molars is extraction since thereis little evidence of an alternative medicament whichis as effective as formocresol and which exhibitsminimal technique sensitivity Pulpectomy remainsan option for the future but staff training will berequired before the technique can be introduced inthe clinical setting and taught at undergraduate levelThe management of the partially vital primary molarmerits further research and discussion since the evid-ence is scant for the use of Ledermixtrade (BlackwellSupplies Ltd Gillingham UK) in such teeth

In order to justify its use within an NHS teachinghospital a medicament must be effective from botha clinical and an economical perspective Mineraltrioxide aggregate has been previously excluded insome centres on the basis of its expense but researchwould suggest that MTA does have a role to playin the treatment of carefully selected primary molarvital pulpotomies and that its cost is comparable tothat of ferric sulphate

Ferric sulphate appears to be as effective in vitalpulpotomies as formocresol and there is no evid-ence to date to suggest any adverse effects of thismedicament As such within the protocol it waschosen as the treatment of choice for vital pulpot-omies Further research and audit is required tobuild on the existing evidence base for ferric sulphatein particular the authors would welcome morelong-term randomised clinical trials

It has been suggested that the careful monitoringof primary teeth with extensive caries is a reason-able treatment option when combined with a thoroughpreventive regimen [7071] The authors suggest that

Development of a pulp therapy protocol

203

copy 2006 BSPD and IAPD

Fig 1 Primary molar protocol (MH) medical history (LA) local anaesthesia (RA) relative analgesia (GA) general anaesthesia (ADJ) amelodentinaljunction (GIC) glass ionomer cement (ZnOE) zinc oxide eugenol cement (PFMC) preformed metal crown and (GDP) general dental practitioner

204

C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

monitoring may be appropriate but only for patientswho are unable to accept operative treatment andwhere the tooth is asymptomatic and clinically andradiographically free of pathology It is advisablethat this decision is made with the consent of a fullyinformed parent because of the potential risk ofdamage to the permanent successor Monitoring isnot an option for patients to whom infection posesa significant risk for example those with leukaemiaor congenital heart defects

Radiographic review

Regular radiographic monitoring of treated teethis advocated to assist in the assessment of primarymolar and permanent successor teeth A radiographtaken after treatment would enable detection ofrecurrent caries a failing coronal restoration peri-apical or furcal radiolucencies internal or externalroot resorption failure of eruption of the permanentsuccessor tooth along its expected path and patho-sis with or without concomitant clinical symptomswhich may damage or deflect the permanent toothgerm [50]

Although the literature relating to the frequencyof radiographing pulpotomised teeth is scant theFaculty of General Dental Practitioners [72] clearlyoutlines selection criteria for radiographic screeningaccording to caries risk status These guidelines sug-gest that bitewing radiographs should be taken on a6-monthly basis for children identified as high cariesrisk and on an annual basis for those classified asmoderate risk The authors would suggest that a

vertical bitewing radiograph could be taken as part ofthis radiographic review because this would enablea review after pulp therapy without an increase inradiation dose

Conclusion

Following a review of the current literature a workingclinical protocol for pulp therapy techniques in theextensively carious primary molar has been developedThis protocol has been implemented at the under-graduate and postgraduate levels and has helped toidentify areas where further staff training is requiredIt is expected that the clinical protocol will evolve asfurther evidence comes to light

Acknowledgements

The authors would like to thank the following fortheir significant contributions to the developmentof the protocol Dr Andrew Shaw Dr Ben ColeDr Anne Maguire Dr Loraine Lowry Mrs VirginiaHind and Mrs Solape Adeboye

References

1 Buckley JP The chemistry of pulp decomposition with arational treatment for this condition and its sequelae

AmericanDental Journal

1904

3

764ndash7712 Sweet CA Jr Procedure for treatment of exposed and pulpless

deciduous teeth

Journal of the American Dental Association

1930

17

1150ndash11533 Roslashlling I Thylstrup A A 3-year clinical follow-up study of

pulpotomised primary molars treated with the formocresoltechnique

Scandinavian Journal of Dental Research

1975

83

47ndash534 Magnusson BO Therapeutic pulpotomies in primary molars

with the formocresol technique A clinical and histologicalfollow-up

Acta Odontologica Scandinavica

1978

36

157ndash165

5 Mejagravere I Pulpotomy of primary molars with coronal or totalpulpitis using formocresol technique

Scandinavian Journalof Dental Research

1979

87

208ndash2166 Magnusson BO Pulpotomy in primary molars long term

clinical and histological evaluation

International EndodonticJournal

1980

13

143ndash1557 Verco PJW Allen KR Formocresol pulpotomies in primary

teeth

Journal of the International Association of Dentistryfor Children

1984

15

51ndash558 Hicks MJ Barr ES Flaitz CM Formocresol pulpotomies in

primary molars a radiographic study in a paediatric dentistrypractice

Journal of Pedodontics

1986

10

331ndash3399 Morawa AP Straffon LH Han SS Copron RE Clinical

evaluation of pulpotomies using dilute formocresol

ASDCJournal of Dentistry for Children

1975

42

360ndash36310 Fuks AB Bimstein E Clinical evaluation of diluted formocresol

What this paper adds

bull This paper highlights the stages in the development ofa local clinical protocol

bull The protocol consisted of a flow chart to assist cliniciansin their treatment planning combined with a key pointsdocument to offer further information and to standardisedata for future research and audit

Why this paper is important for paediatric dentists

bull Prior to the use of any clinical intervention the evidencebase behind it requires consideration

bull In order to justify its use within any clinical setting (beit primary dental care or an NHS teaching hospital)a medicament or technique must be effective from aclinical and economical perspective

bull Ferric sulphate was chosen within our protocol as thetreatment of choice for vital pulpotomies as it appearsto be as effective as fromocresol in vital pulpotomies todate and there is no evidence to suggest any adverseeffects from this medicament

Development of a pulp therapy protocol

205

copy 2006 BSPD and IAPD

pulpotomies in primary teeth of schoolchildren

PediatricDentistry

1981

3

321ndash32411 Garcia-Godoy F Direct pulp capping and partial pulpotomy

with diluted formocresol in primary molars

Acta de OdontologicaPediatrica

1984

5

57ndash6112 Prakash C Chandra S Jaiswal JN Formocresol and glutaralde-

hyde pulpotomies in primary teeth

Journal of Pedodontics

1989

13

314ndash32213 Formaldehyde Panel

Report of the Federal Panel on Formaldehyde

Research Triangle Park NC National Toxicology Program 1980

14 Lewis BB Chestner SB Formaldehyde in dentistry a reviewof mutagenic and carcinogenic potential

Journal of the AmericanDental Association

1981

103

429ndash43415 Block RM Lewis RD Hirsch J Coffey J Langeland K Systemic

distribution of

14

C-labeled paraformaldehyde incorporatedwithin formocresol following pulpotomies in dogs

Journal ofEndodontics

1983

9

176ndash18916 Waterhouse PJ Formocresol and alternative primary molar

pulpotomy medicaments a review

Endodontics and DentalTraumatology

1995

11

157ndash16217 Judd PL Kenny DJ Formocresol concerns a review

Journalof the Canadian Dental Association

1987

5

401ndash40418 Wilkins RJ McLeod HD Formaldehyde induced DNA-protein

cross-links in

Escherichia coli

Mutation Research

1976

36

11ndash16

19 Takahashi K Morita T Kawazoe Y Mutagenic characteristicsof formaldehyde on bacterial systems

Mutation Research

1985

156

153ndash16120 Kaplan WD Formaldehyde as a mutagen in Drosophila

Science

1948

108

4321 Soffritti M Belpoggi F Lambertin L Lauriola M Padovani M

Maltoni C Results of long-term experimental studies on thecarcinogenicity of formaldehyde and acetaldehyde in rats

Annals of the New York Academy of Sciences

2002

982

87ndash105

22 Swenberg JA Kerns WD Mitchell RI Gralla EJ Pavkov KLInduction of squamous cell carcinomas of the rat nasalcavity by inhalation exposure to formaldehyde vapour

CancerResearch

1980

40

3398ndash340223 Mueller R Raabe G Schumann D Leukoplakia induced by

repeated deposition of formalin in rabbit oral mucosa longterm experiments in a new lsquooral tankrsquo

Experimental Pathology

1978

16

36ndash4224 Bolt HM Experimental toxicology of formaldehyde

Journalof Cancer Research and Clinical Oncology

1987

113

305ndash30925 Bernstein RS Stayner LT Elliot LI Kimbrough RK Inhala-

tion exposure to formaldehyde an overview of its toxicologyepidemiology monitoring and control

American IndustrialHygiene Association Journal

1984

45

778ndash78526 Goldmacher VS Thilly WD Formaldehyde is mutagenic for

cultured human cells

Mutation Research

1983

116

417ndash422

27 He JL Jin LF Jin HY Detection of cytogenic effects inperipheral lymphocytes of students exposed to formaldehydewith cytokinesis-blocked micronucleus assay

Biomedical andEnvironmental Sciences

1998

11

87ndash9228 Bauchinger M Schmid E Cytogenic effects in lymphocytes

of formaldehyde workers of a paper factory

MutationResearch

1985

158

195ndash19929 Kitaeva LV Mikheeva EA Shelomova LF Shvartsman PI

Genotoxic effect of formaldehyde in somatic human cells

invivo

[in Russian]

Genetika

1996

32

1287ndash129030 Suruda A Schulte P Boeniger M

et al

Cytogenetic effectsof formaldehyde exposure in students of mortuary science

Cancer Epidemiology Biomarkers and Prevention

1993

2

453ndash460

31 Shaham J Bomstein Y Meltzer A Ribak J DNA-proteincrosslinks a biomarker of exposure to formaldehyde ndash

invitro

and

in vivo

studies

Carcinogenesis

1996

17

121ndash12532 Shaham J Bomstein Y Meltzer A Kaufman Z Palma E

Ribak J DNA-protein crosslinks and sister chromatidexchanges as biomarkers of exposure to formaldehyde

Inter-national Journal of Occupational Medicine and EnvironmentalHealth

1997

3

95ndash10433 Yager JW Cohn KL Spear RC Fisher JM Morse L Sister-

chromatid exchanges in lymphocytes of anatomy studentsexposed to formaldehyde embalming solution

MutationResearch

1986

174

135ndash13934 Shaham J Gurvich R Kaufman Z Sister chromatid exchange

in pathology staff occupationally exposed to formaldehyde

Mutation Research

2002

15

115ndash12335 Bonassi S Hagmar L Stromberg U

et al

Chromosomal aber-rations in lymphocytes predict human cancer independentlyof exposure to carcinogens European Study Group onCytogenetic Biomarkers and Health

Cancer Research

2000

60

1619ndash162536 Tucker JD Preston RJ Chromosome aberrations micronuclei

aneuploidy sister chromatid exchanges and cancer riskassessment

Mutation Research

1996

365

147ndash15937 Hauptmann M Lubin JH Stewart PA Hayes RB Blair A

Mortality from lymphohematopoietic malignancies amongworkers in formaldehyde industries

Journal of the NationalCancer Institute

2003

95

1615ndash162338 Pinkerton L Hein M Stayner L Mortality among a cohort

of garment workers exposed to formaldehyde an update

Occupational and Environmental Medicine

2004

61

193ndash200

39 Coggon D Harris EC Poole J

et al

Extended follow-up ofa cohort of British chemical workers exposed to formaldehyde

Journal of the National Cancer Institute

2003

21

1608ndash161440 Bertazzi PA Pesatori AC Radice L Zocchetti C Vai T

Exposure to formaldehyde and cancer mortality in a cohortof workers producing resins

Scandinavian Journal of WorkEnvironment and Health

1986

12

461ndash46841 Hauptmann M Lubin JH Stewart PA Hayes RB Blair A

Mortality from solid cancers among workers in formaldehydeindustries

American Journal of Epidemiology

2004

159

1117ndash1130

42 Blair A Stewart P OrsquoBerg M

et al

Mortality among indus-trial workers exposed to formaldehyde

Journal of theNational Cancer Institute

1986

76 1071ndash108443 Gardner MJ Pannett B Winter PD Cruddas AM A cohort

study of workers exposed to formaldehyde in the Britishchemical industry an update British Journal of IndustrialMedicine 1993 50 827ndash834

44 Hayes RB Blair A Stewart PA Herrick RF Mahar HMortality of US embalmers and funeral directors AmericanJournal of Industrial Medicine 1990 18 641ndash652

45 Collins JJ Esmen NA Hall TA A review and meta-analysisof formaldehyde exposure and pancreatic cancer AmericanJournal of Industrial Medicine 2001 39 336ndash345

46 Pashley EL Nelson R Pashley DH Systemic distribution of14C-formaldehyde with formocresol-treated pulpotomy sitesJournal of Dental Research 1980 59 603ndash608

47 Myers DR Shoaf HK Dirksen TR Distribution of 14C-formaldehyde after pulpotomy with formocresol Journal ofthe American Dental Association 1978 96 805ndash813

48 Zarzar PA Rosenblatt A Takahashi CS Takeuchi PL Costa

206 C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

LA Jr Formocresol mutagenicity following primary toothpulp therapy an in vivo study Journal of Dentistry 2003 31479ndash485

49 Messer LB Cline JT Korf NW Long-term effects of primarymolar pulpotomies on succedaneous bicuspids Journal ofDental Research 1980 29 116ndash123

50 Waterhouse PJ A comparison of the relative efficacy offormocresol versus calcium hydroxide as vital pulp therapyagents in primary molars PhD Thesis Newcastle upon TyneUniversity of Newcastle upon Tyne 2000

51 International Agency for Research on Cancer Press releaseno 153 15 June 2004 [WWW document] URL httpwwwiarcfrpagerootPRELEASESpr153ahtml

52 National Pathways Association NPA definition of a pathwayof care NPA Newsletter 1998 Spring 2

53 Currie L Harvey G The Origins and Uses of Care Pathwaysin the USA Australia and the United Kingdom Report No 15London RCN Institute Oxford Centre Royal College ofNursing 1997

54 Hale C Issues in the evaluation of multidisciplinary pathwaysof care In Wilson J (ed) Integrated Care Management The Pathto Success Oxford Butterworth-Heinemann 1987 281ndash296

55 de Luc K Care pathways an evaluation of their effectivenessJournal of Advanced Nursing 2000 32 485ndash496

56 Currie L Care pathways development and implementationNursing Standard 1998 12 35ndash38

57 Goel V Decision analysis applications and limitationsCanadian Medical Association Journal 1992 147 413ndash417

58 Richardson WS Detsky AS Usersrsquo guides to the medicalliterature VII How to use a clinical decision analysis Arethe results of the study valid Journal of the American MedicalAssociation 1995 273 1292ndash1295

59 Ibricevic H Al-Jame Q Ferric sulfate as pulpotomy agent inprimary teeth twenty month clinical follow-up PediatricDentistry 2000 24 269ndash272

60 Ibricevic H Al-Jame Q Ferric sulphate and formocresol inpulpotomy of primary molars long term follow-up studyEuropean Journal of Paediatric Dentistry 2003 4 28ndash32

61 Casas MJ Kenny DJ Johnston DH Judd PJ Long-term out-comes of primary molar ferric sulfate pulpotomy and rootcanal therapy Pediatric Dentistry 2004 26 44ndash48

62 Papagiannoulis L Clinical studies on ferric sulphate as apulpotomy medicament in primary teeth European Journalof Paediatric Dentistry 2002 3 126ndash132

63 Salako N Joseph B Ritwik P Salonen J John P Junaid TAComparison of bioactive glass mineral trioxide aggregateferric sulphate and formocresol as pulpotomy agents in ratmolar Dental Traumatology 2003 19 314ndash320

64 Casas MJ Kenny DJ Johnston DH Judd PL Layug MAOutcomes of vital primary incisor ferric sulphate pulpotomyand root canal therapy Journal of the Canadian Dental Asso-ciation 2004 70 34ndash38

65 Casas MJ Layug MA Kenny DJ Johnston DH Judd PLTwo-year outcomes of primary molar ferric sulphate pulpot-omy and root canal therapy Pediatric Dentistry 2003 25 97ndash102

66 Cleaton-Jones P Duggal M Parak M Williams S Setze SFerric sulphate and formocresol pulpotomies in baboonprimary molars histological responses European Journal ofPaediatric Dentistry 2002 3 121ndash125

67 Dominguez MS Witherspoon DE Gutmann JL OppermanLA Histological and scanning electron microscopy assess-ment of various vital pulp-therapy materials Journal of Endo-dontics 2003 29 324ndash333

68 Waterhouse PJ Whitworth JM Nunn JH Development of amethod to detect and quantify Prostaglandin E2 in pulpalblood from cariously exposed vital primary molar teethInternational Endodontic Journal 1999 32 381ndash387

69 Waterhouse PJ Nunn JH Whitworth JM Prostaglandin E2and treatment outcome in pulp therapy of primary molarswith carious exposures International Journal of PaediatricDentistry 2002 12 116ndash123

70 Tickle M Milsom K King D Kearney-Mitchell P BlinkhornA The fate of the carious primary teeth of children whoregularly attend the general dental service British DentalJournal 2002 192 219ndash223

71 Milsom K Tickle M King D Does the dental professionknow how to care for the primary dentition British DentalJournal 2003 195 301ndash303

72 Pendlebury ME Horner K Eaton KA (eds) Selection Criteriafor Dental Radiography 2nd edn London Faculty of GeneralDental Practitioners (UK) The Royal College of Surgeons ofEngland 2004

73 Fuks AB Bimstein E Kelin H Assessment of a 2 percentbuffered glutaraldehyde solution in pulpotomized primaryteeth of school children a preliminary report Journal ofPedodontics 1986 10 323ndash330

74 Mack RB Dean JA Electrosurgical pulpotomy a retrospec-tive human study Journal of Dentistry for Children 1993 60107ndash114

75 Agamy HA Bakry NS Mounir MMF Avery DR Comparisonof mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth PediatricDentistry 2004 26 302ndash309

76 Elliot RD Roberts MW Burkes J Phillips C Evaluation ofthe carbon dioxide laser on vital human primary pulp tissuePaediatric Dentistry 1999 21 327ndash331

77 Al-Zayer MA Straffon LH Feigal RJ Welch KB Indirectpulp treatment of primary posterior teeth a retrospectivestudy Pediatric Dentistry 2003 25 29ndash36

78 Hansen HP Ravn JJ Ulrich D Vital pulpotomy in primarymolars A clinical and histological investigation of the effectof zinc-oxide eugenol cement and Ledermix ScandinavialJournal of Dental Research 1971 79 13ndash23

200

C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

exchanges [2732ndash34] have been found in peripherallymphocytes of humans exposed to formaldehydeAlthough there is an established link between chro-mosomal aberrations and cancer [35] the relation-ships between micronuclei or sister chromatid exchangesand health risks are less clear [36]

Human cohort studies

Long-term cohort studies of industrial workershave found increased risks for leukaemia particu-larly myeloid leukaemia in medical workers andother professionals exposed to formaldehyde [3738]whilst other research does not support these findings[39] Possible associations have also been suggestedbetween occupational formaldehyde and cancer ofthe lung [3940] nasopharynx [3941] stomach[39] paranasal sinuses [4243] prostate [4144]brain [44] and pancreas [45] However theseassociations remain inconsistent

Dental studies

Systemic distribution of radio-isotope-labelledformaldehyde has been demonstrated followingformocresol pulpotomy in dogs [46] and rhesusmonkeys [47] Labelled formaldehyde has been foundin periodontal ligament bone dentine and urine andsmaller amounts in the liver kidney lungs skeletalmuscle and cerebrospinal fluid within minutes of thepulpotomy [46] More recently a human case controlstudy demonstrated a single case of mutagenicity inperipheral blood lymphocyte cultures followingformocresol pulpotomy [48] A correlation betweenformocresol pulpotomies in primary teeth and enameldefects in the permanent successor has been sug-gested [49] although other workers found no suchlinks [50]

In June 2004 the International Agency forResearch on Cancer (IARC) classified formaldehydeas carcinogenic to human beings [51] The expertworking group determined that there is now sufficientevidence that formaldehyde causes nasopharyngealcancer in humans limited evidence for cancer of thenasal cavity and paranasal sinuses and strong butnot sufficient evidence for a causal association betweenleukaemia and occupational exposure to formaldehydeThe IARC working group recommended furtherresearch in order to identify a mechanism for theinduction of leukaemia and to build on the existingevidence base

Care pathways clinical protocols and decision trees

The National Pathway Association was founded in1994 to support the development of integrated carepathways A care pathway determines locallyagreed multidisciplinary practice based on guide-lines and evidence where available for a specificpatient group It forms all or part of the clinicalrecord documents the care given and facilitates theevaluation of outcomes for continuous qualityimprovement [52]

A clinical protocol is a written framework for theexpected management path and outcome for apatient undergoing a particular procedure Clinicalprotocols and care pathways are being widely imple-mented in the National Health Service (NHS) andalthough concerns were initially expressed regardingthe lack of evidence for their efficacy [5354] recentwork has helped to address this issue It wouldappear that both are capable of improving qualityof care and patient satisfaction [55] The aim of aclinical protocol is to improve the quality of careand ensure that treatment is based on the latestevidence and research They should complementrather than abolish intuitive thought based on clinicalexpertise Education and training strategies areessential to support understanding ownership andacceptance [56]

Decision analysis is the application of structuredquantitative methods to analyse decisions underconditions of uncertainty [57] They can be showngraphically as decision trees and help to structureproblems and highlight areas for further researchDecision analysis works on the principle that thedegree of uncertainty decreases when the medicalliterature includes directly relevant and valid evidence[58]

Materials and methods

Protocol development

On 15 June 2004 the IARC issued a press releaseclassifying formaldehyde as carcinogenic to humanbeings [51] This information was circulated to allconsultants in paediatric dentistry and resulted in thewithdrawal of Buckleyrsquos formocresol and all para-formaldehyde-containing devitalising pastes fromthe majority of teaching hospitals In the Departmentof Child Dental Health Newcastle Dental HospitalNewcastle upon Tyne UK a specialist group of

Development of a pulp therapy protocol

201

copy 2006 BSPD and IAPD

paediatric dentists comprising consultants specialistregistrars university academics and a staff grade wasformed in order to establish a consensus decision on themanagement of extensively carious primary molar teeth

A traditional narrative literature review was com-pleted (Part I of this publication) and primaryresearch papers for each of the possible alternativesto formocresol were identified Where possible ran-domised control trials were chosen to evaluate clinicaland radiographic success for each medicament [59ndash65] Histological animal studies were identified toenable comparison between the cytological andtoxicological effects of different medicaments andtechniques [6667] Each clinician in the specialistgroup was asked to critically appraise their allocatedpapers and to present their findings at a lsquobrainstormingrsquosession

Following appraisal of the selected publicationsthe group discussed the ideal properties of a pulptherapy agent and tabulated the key findings of thereview (Table 1) It was felt that in light of therecent IARC findings it was necessary to implementthe chosen alternatives as soon as possible whilstalso considering techniques which may be possiblein the future

For inclusion in the protocol it was necessary fora technique or medicament to have a sufficientevidence base ideally human trials for clinical efficacyand to be economical in order to justify its routineuse within an NHS teaching hospital There shouldalso be little immediate financial outlay or trainingimplications to allow rapid introduction of theprotocol

On this basis ferric sulphate (AstringedentUltradent Products Inc South Jordan UT USA)was chosen for use in the vital primary molar pulpot-omy Although concerns were expressed that thisagent may mask underlying pulp pathosis it was feltthat it was clinically successful operator- and patient-friendly and a financially viable medicament Mineraltrioxide aggregate (MTA Pro Root Dentsply TulsaDental Weybridge UK) will also be an option for staff-performed pulpotomies and perhaps introduced intothe undergraduate arena in the future

A working draft of the protocol was produced andcirculated to enter into the lsquoiterativersquo process ofreview The draft protocol consisted of a flow chart toassist clinicians in their treatment planning combinedwith a key points document to offer further infor-mation and to standardise data for future research

Table 1 Comparison of alternatives to formocresol for pulp therapy (MTA) mineral trioxide aggregate (IPT) indirect pulp therapyand (BMP) bone morphogenic protein

MaterialClinical success(example cited)

Human clinical studies

Tested against

formocresol

Operator ease of

usePatient

acceptabilityCost of

techniqueEffect upon

pulp cell

Glutaraldehyde 82 over 25 months Yes Yes Good Good Low DevitalisationFuks et al [73]

Electrosurgery 99middot4 over 70 months No No Poor Poor Medium DevitalisationMack and Dean [74]

Ferric sulphate 92 over 4 years Yes Yes Good Good Low PreservationIbrecevic [60]

Calcium hydroxide 77middot1 over 22middot5 months Yes Yes Good Good Low PreservationWaterhouse [50]

MTA 100 over one year (grey) Yes No Fair Good High Preservation84middot2 over one year (white)Agamy et al [75]

Lasers 100 over 90 days Yes Yes Poor Poor High PreservationElliot et al [76]

IPT 95 over 2ndash72 weeks Yes Yes Good Good Low RemineralisationAl Zayer et al [77]

BMP No studies No No Unknown Unknown Unknown Remineralisation

Collagen No studies No No Unknown Unknown Unknown Remineralisation

Pulpectomy 91 over 36 months Yes Yes Poor Poor Low ExtirpationCasas and Kenny [61]

Ledermix 79 over 42 month Yes No Good Good Low PreservationHansen et al [78]

202

C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

and audit Each draft version was then circulated forcomment a further three times This resulted in theworking protocol (Fig 1) To facilitate future auditof the protocol every time pulp therapy is per-formed within the Department a stamp will beused to record standardised information in thepatientrsquos notes for example the time taken toachieve haemostasis and the number of applicationsof ferric sulphate required The information will alsobe recorded in a lsquopulp therapy bookrsquo

Implementation of the protocol

Undergraduate dental students were informed ofchanges in protocol via information uploaded withinthe University Virtual Learning Environment Inaddition a lecture was given to all third-year studentsprior to their initial clinical sessions within paedi-atric dentistry and an existing seminar was revisedto include an update on pulp therapy in the primarydentition The same information was supplied to allteachers of paediatric dentistry within the school andin outreach clinics It is expected that further modifi-cations to the teaching programme will be made aspulp therapy techniques are developed and audited

The working protocol and key points documentwere circulated to all staff working within thedepartment Discussion of these documents wasincorporated into the junior staff induction programmeNursing staff were also informed of the new techniquesand proposed local protocols via the senior nurseAreas for future staff training were identified at theteam meeting and hands-on training for specialiststaff has been arranged for the near future

Discussion

Following the recent IARC press release [51] theuse of formocresol in paediatric dentistry is nolonger recommended and clinicians must adoptalternative evidence-based procedures The authorsacknowledge that the evidence for some of thealternatives to formocresol is weak However theIARC statement demands a change to currentpractice and an urgent review of the alternatives inorder to develop an interim protocol It is hoped thatthis protocol will add to the debate and enable thecollection of standardised data which will in turnlead to a more evidence-based guideline in the future

The importance of careful patient and tooth selectionwhen considering provision of a pulp therapy cannot

be overemphasised In order for vital pulp therapyto be successful the patient must be sufficientlycompliant to allow adequate moisture control ideallywith rubber dam placement and the tooth must beradiographically free of pathology and restorablewith a bonded restoration or preformed metal crownin order to provide an effective seal

Despite careful initial assessment diagnosis ofpulpal status may be difficult For example once anirreversibly inflamed coronal pulp has been ampu-tated the health of the radicular pulp is assessed onan empirical basis ie how readily the pulp stumpbleeds As yet we have no scientific clinical methodof determining pulpal status prior to treatmentalthough there has been some work to investigatecorrelations between the presence of certain inflam-matory mediators and clinical outcome [6869]

Presently in Newcastle the treatment of choicefor nonvital primary molars is extraction since thereis little evidence of an alternative medicament whichis as effective as formocresol and which exhibitsminimal technique sensitivity Pulpectomy remainsan option for the future but staff training will berequired before the technique can be introduced inthe clinical setting and taught at undergraduate levelThe management of the partially vital primary molarmerits further research and discussion since the evid-ence is scant for the use of Ledermixtrade (BlackwellSupplies Ltd Gillingham UK) in such teeth

In order to justify its use within an NHS teachinghospital a medicament must be effective from botha clinical and an economical perspective Mineraltrioxide aggregate has been previously excluded insome centres on the basis of its expense but researchwould suggest that MTA does have a role to playin the treatment of carefully selected primary molarvital pulpotomies and that its cost is comparable tothat of ferric sulphate

Ferric sulphate appears to be as effective in vitalpulpotomies as formocresol and there is no evid-ence to date to suggest any adverse effects of thismedicament As such within the protocol it waschosen as the treatment of choice for vital pulpot-omies Further research and audit is required tobuild on the existing evidence base for ferric sulphatein particular the authors would welcome morelong-term randomised clinical trials

It has been suggested that the careful monitoringof primary teeth with extensive caries is a reason-able treatment option when combined with a thoroughpreventive regimen [7071] The authors suggest that

Development of a pulp therapy protocol

203

copy 2006 BSPD and IAPD

Fig 1 Primary molar protocol (MH) medical history (LA) local anaesthesia (RA) relative analgesia (GA) general anaesthesia (ADJ) amelodentinaljunction (GIC) glass ionomer cement (ZnOE) zinc oxide eugenol cement (PFMC) preformed metal crown and (GDP) general dental practitioner

204

C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

monitoring may be appropriate but only for patientswho are unable to accept operative treatment andwhere the tooth is asymptomatic and clinically andradiographically free of pathology It is advisablethat this decision is made with the consent of a fullyinformed parent because of the potential risk ofdamage to the permanent successor Monitoring isnot an option for patients to whom infection posesa significant risk for example those with leukaemiaor congenital heart defects

Radiographic review

Regular radiographic monitoring of treated teethis advocated to assist in the assessment of primarymolar and permanent successor teeth A radiographtaken after treatment would enable detection ofrecurrent caries a failing coronal restoration peri-apical or furcal radiolucencies internal or externalroot resorption failure of eruption of the permanentsuccessor tooth along its expected path and patho-sis with or without concomitant clinical symptomswhich may damage or deflect the permanent toothgerm [50]

Although the literature relating to the frequencyof radiographing pulpotomised teeth is scant theFaculty of General Dental Practitioners [72] clearlyoutlines selection criteria for radiographic screeningaccording to caries risk status These guidelines sug-gest that bitewing radiographs should be taken on a6-monthly basis for children identified as high cariesrisk and on an annual basis for those classified asmoderate risk The authors would suggest that a

vertical bitewing radiograph could be taken as part ofthis radiographic review because this would enablea review after pulp therapy without an increase inradiation dose

Conclusion

Following a review of the current literature a workingclinical protocol for pulp therapy techniques in theextensively carious primary molar has been developedThis protocol has been implemented at the under-graduate and postgraduate levels and has helped toidentify areas where further staff training is requiredIt is expected that the clinical protocol will evolve asfurther evidence comes to light

Acknowledgements

The authors would like to thank the following fortheir significant contributions to the developmentof the protocol Dr Andrew Shaw Dr Ben ColeDr Anne Maguire Dr Loraine Lowry Mrs VirginiaHind and Mrs Solape Adeboye

References

1 Buckley JP The chemistry of pulp decomposition with arational treatment for this condition and its sequelae

AmericanDental Journal

1904

3

764ndash7712 Sweet CA Jr Procedure for treatment of exposed and pulpless

deciduous teeth

Journal of the American Dental Association

1930

17

1150ndash11533 Roslashlling I Thylstrup A A 3-year clinical follow-up study of

pulpotomised primary molars treated with the formocresoltechnique

Scandinavian Journal of Dental Research

1975

83

47ndash534 Magnusson BO Therapeutic pulpotomies in primary molars

with the formocresol technique A clinical and histologicalfollow-up

Acta Odontologica Scandinavica

1978

36

157ndash165

5 Mejagravere I Pulpotomy of primary molars with coronal or totalpulpitis using formocresol technique

Scandinavian Journalof Dental Research

1979

87

208ndash2166 Magnusson BO Pulpotomy in primary molars long term

clinical and histological evaluation

International EndodonticJournal

1980

13

143ndash1557 Verco PJW Allen KR Formocresol pulpotomies in primary

teeth

Journal of the International Association of Dentistryfor Children

1984

15

51ndash558 Hicks MJ Barr ES Flaitz CM Formocresol pulpotomies in

primary molars a radiographic study in a paediatric dentistrypractice

Journal of Pedodontics

1986

10

331ndash3399 Morawa AP Straffon LH Han SS Copron RE Clinical

evaluation of pulpotomies using dilute formocresol

ASDCJournal of Dentistry for Children

1975

42

360ndash36310 Fuks AB Bimstein E Clinical evaluation of diluted formocresol

What this paper adds

bull This paper highlights the stages in the development ofa local clinical protocol

bull The protocol consisted of a flow chart to assist cliniciansin their treatment planning combined with a key pointsdocument to offer further information and to standardisedata for future research and audit

Why this paper is important for paediatric dentists

bull Prior to the use of any clinical intervention the evidencebase behind it requires consideration

bull In order to justify its use within any clinical setting (beit primary dental care or an NHS teaching hospital)a medicament or technique must be effective from aclinical and economical perspective

bull Ferric sulphate was chosen within our protocol as thetreatment of choice for vital pulpotomies as it appearsto be as effective as fromocresol in vital pulpotomies todate and there is no evidence to suggest any adverseeffects from this medicament

Development of a pulp therapy protocol

205

copy 2006 BSPD and IAPD

pulpotomies in primary teeth of schoolchildren

PediatricDentistry

1981

3

321ndash32411 Garcia-Godoy F Direct pulp capping and partial pulpotomy

with diluted formocresol in primary molars

Acta de OdontologicaPediatrica

1984

5

57ndash6112 Prakash C Chandra S Jaiswal JN Formocresol and glutaralde-

hyde pulpotomies in primary teeth

Journal of Pedodontics

1989

13

314ndash32213 Formaldehyde Panel

Report of the Federal Panel on Formaldehyde

Research Triangle Park NC National Toxicology Program 1980

14 Lewis BB Chestner SB Formaldehyde in dentistry a reviewof mutagenic and carcinogenic potential

Journal of the AmericanDental Association

1981

103

429ndash43415 Block RM Lewis RD Hirsch J Coffey J Langeland K Systemic

distribution of

14

C-labeled paraformaldehyde incorporatedwithin formocresol following pulpotomies in dogs

Journal ofEndodontics

1983

9

176ndash18916 Waterhouse PJ Formocresol and alternative primary molar

pulpotomy medicaments a review

Endodontics and DentalTraumatology

1995

11

157ndash16217 Judd PL Kenny DJ Formocresol concerns a review

Journalof the Canadian Dental Association

1987

5

401ndash40418 Wilkins RJ McLeod HD Formaldehyde induced DNA-protein

cross-links in

Escherichia coli

Mutation Research

1976

36

11ndash16

19 Takahashi K Morita T Kawazoe Y Mutagenic characteristicsof formaldehyde on bacterial systems

Mutation Research

1985

156

153ndash16120 Kaplan WD Formaldehyde as a mutagen in Drosophila

Science

1948

108

4321 Soffritti M Belpoggi F Lambertin L Lauriola M Padovani M

Maltoni C Results of long-term experimental studies on thecarcinogenicity of formaldehyde and acetaldehyde in rats

Annals of the New York Academy of Sciences

2002

982

87ndash105

22 Swenberg JA Kerns WD Mitchell RI Gralla EJ Pavkov KLInduction of squamous cell carcinomas of the rat nasalcavity by inhalation exposure to formaldehyde vapour

CancerResearch

1980

40

3398ndash340223 Mueller R Raabe G Schumann D Leukoplakia induced by

repeated deposition of formalin in rabbit oral mucosa longterm experiments in a new lsquooral tankrsquo

Experimental Pathology

1978

16

36ndash4224 Bolt HM Experimental toxicology of formaldehyde

Journalof Cancer Research and Clinical Oncology

1987

113

305ndash30925 Bernstein RS Stayner LT Elliot LI Kimbrough RK Inhala-

tion exposure to formaldehyde an overview of its toxicologyepidemiology monitoring and control

American IndustrialHygiene Association Journal

1984

45

778ndash78526 Goldmacher VS Thilly WD Formaldehyde is mutagenic for

cultured human cells

Mutation Research

1983

116

417ndash422

27 He JL Jin LF Jin HY Detection of cytogenic effects inperipheral lymphocytes of students exposed to formaldehydewith cytokinesis-blocked micronucleus assay

Biomedical andEnvironmental Sciences

1998

11

87ndash9228 Bauchinger M Schmid E Cytogenic effects in lymphocytes

of formaldehyde workers of a paper factory

MutationResearch

1985

158

195ndash19929 Kitaeva LV Mikheeva EA Shelomova LF Shvartsman PI

Genotoxic effect of formaldehyde in somatic human cells

invivo

[in Russian]

Genetika

1996

32

1287ndash129030 Suruda A Schulte P Boeniger M

et al

Cytogenetic effectsof formaldehyde exposure in students of mortuary science

Cancer Epidemiology Biomarkers and Prevention

1993

2

453ndash460

31 Shaham J Bomstein Y Meltzer A Ribak J DNA-proteincrosslinks a biomarker of exposure to formaldehyde ndash

invitro

and

in vivo

studies

Carcinogenesis

1996

17

121ndash12532 Shaham J Bomstein Y Meltzer A Kaufman Z Palma E

Ribak J DNA-protein crosslinks and sister chromatidexchanges as biomarkers of exposure to formaldehyde

Inter-national Journal of Occupational Medicine and EnvironmentalHealth

1997

3

95ndash10433 Yager JW Cohn KL Spear RC Fisher JM Morse L Sister-

chromatid exchanges in lymphocytes of anatomy studentsexposed to formaldehyde embalming solution

MutationResearch

1986

174

135ndash13934 Shaham J Gurvich R Kaufman Z Sister chromatid exchange

in pathology staff occupationally exposed to formaldehyde

Mutation Research

2002

15

115ndash12335 Bonassi S Hagmar L Stromberg U

et al

Chromosomal aber-rations in lymphocytes predict human cancer independentlyof exposure to carcinogens European Study Group onCytogenetic Biomarkers and Health

Cancer Research

2000

60

1619ndash162536 Tucker JD Preston RJ Chromosome aberrations micronuclei

aneuploidy sister chromatid exchanges and cancer riskassessment

Mutation Research

1996

365

147ndash15937 Hauptmann M Lubin JH Stewart PA Hayes RB Blair A

Mortality from lymphohematopoietic malignancies amongworkers in formaldehyde industries

Journal of the NationalCancer Institute

2003

95

1615ndash162338 Pinkerton L Hein M Stayner L Mortality among a cohort

of garment workers exposed to formaldehyde an update

Occupational and Environmental Medicine

2004

61

193ndash200

39 Coggon D Harris EC Poole J

et al

Extended follow-up ofa cohort of British chemical workers exposed to formaldehyde

Journal of the National Cancer Institute

2003

21

1608ndash161440 Bertazzi PA Pesatori AC Radice L Zocchetti C Vai T

Exposure to formaldehyde and cancer mortality in a cohortof workers producing resins

Scandinavian Journal of WorkEnvironment and Health

1986

12

461ndash46841 Hauptmann M Lubin JH Stewart PA Hayes RB Blair A

Mortality from solid cancers among workers in formaldehydeindustries

American Journal of Epidemiology

2004

159

1117ndash1130

42 Blair A Stewart P OrsquoBerg M

et al

Mortality among indus-trial workers exposed to formaldehyde

Journal of theNational Cancer Institute

1986

76 1071ndash108443 Gardner MJ Pannett B Winter PD Cruddas AM A cohort

study of workers exposed to formaldehyde in the Britishchemical industry an update British Journal of IndustrialMedicine 1993 50 827ndash834

44 Hayes RB Blair A Stewart PA Herrick RF Mahar HMortality of US embalmers and funeral directors AmericanJournal of Industrial Medicine 1990 18 641ndash652

45 Collins JJ Esmen NA Hall TA A review and meta-analysisof formaldehyde exposure and pancreatic cancer AmericanJournal of Industrial Medicine 2001 39 336ndash345

46 Pashley EL Nelson R Pashley DH Systemic distribution of14C-formaldehyde with formocresol-treated pulpotomy sitesJournal of Dental Research 1980 59 603ndash608

47 Myers DR Shoaf HK Dirksen TR Distribution of 14C-formaldehyde after pulpotomy with formocresol Journal ofthe American Dental Association 1978 96 805ndash813

48 Zarzar PA Rosenblatt A Takahashi CS Takeuchi PL Costa

206 C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

LA Jr Formocresol mutagenicity following primary toothpulp therapy an in vivo study Journal of Dentistry 2003 31479ndash485

49 Messer LB Cline JT Korf NW Long-term effects of primarymolar pulpotomies on succedaneous bicuspids Journal ofDental Research 1980 29 116ndash123

50 Waterhouse PJ A comparison of the relative efficacy offormocresol versus calcium hydroxide as vital pulp therapyagents in primary molars PhD Thesis Newcastle upon TyneUniversity of Newcastle upon Tyne 2000

51 International Agency for Research on Cancer Press releaseno 153 15 June 2004 [WWW document] URL httpwwwiarcfrpagerootPRELEASESpr153ahtml

52 National Pathways Association NPA definition of a pathwayof care NPA Newsletter 1998 Spring 2

53 Currie L Harvey G The Origins and Uses of Care Pathwaysin the USA Australia and the United Kingdom Report No 15London RCN Institute Oxford Centre Royal College ofNursing 1997

54 Hale C Issues in the evaluation of multidisciplinary pathwaysof care In Wilson J (ed) Integrated Care Management The Pathto Success Oxford Butterworth-Heinemann 1987 281ndash296

55 de Luc K Care pathways an evaluation of their effectivenessJournal of Advanced Nursing 2000 32 485ndash496

56 Currie L Care pathways development and implementationNursing Standard 1998 12 35ndash38

57 Goel V Decision analysis applications and limitationsCanadian Medical Association Journal 1992 147 413ndash417

58 Richardson WS Detsky AS Usersrsquo guides to the medicalliterature VII How to use a clinical decision analysis Arethe results of the study valid Journal of the American MedicalAssociation 1995 273 1292ndash1295

59 Ibricevic H Al-Jame Q Ferric sulfate as pulpotomy agent inprimary teeth twenty month clinical follow-up PediatricDentistry 2000 24 269ndash272

60 Ibricevic H Al-Jame Q Ferric sulphate and formocresol inpulpotomy of primary molars long term follow-up studyEuropean Journal of Paediatric Dentistry 2003 4 28ndash32

61 Casas MJ Kenny DJ Johnston DH Judd PJ Long-term out-comes of primary molar ferric sulfate pulpotomy and rootcanal therapy Pediatric Dentistry 2004 26 44ndash48

62 Papagiannoulis L Clinical studies on ferric sulphate as apulpotomy medicament in primary teeth European Journalof Paediatric Dentistry 2002 3 126ndash132

63 Salako N Joseph B Ritwik P Salonen J John P Junaid TAComparison of bioactive glass mineral trioxide aggregateferric sulphate and formocresol as pulpotomy agents in ratmolar Dental Traumatology 2003 19 314ndash320

64 Casas MJ Kenny DJ Johnston DH Judd PL Layug MAOutcomes of vital primary incisor ferric sulphate pulpotomyand root canal therapy Journal of the Canadian Dental Asso-ciation 2004 70 34ndash38

65 Casas MJ Layug MA Kenny DJ Johnston DH Judd PLTwo-year outcomes of primary molar ferric sulphate pulpot-omy and root canal therapy Pediatric Dentistry 2003 25 97ndash102

66 Cleaton-Jones P Duggal M Parak M Williams S Setze SFerric sulphate and formocresol pulpotomies in baboonprimary molars histological responses European Journal ofPaediatric Dentistry 2002 3 121ndash125

67 Dominguez MS Witherspoon DE Gutmann JL OppermanLA Histological and scanning electron microscopy assess-ment of various vital pulp-therapy materials Journal of Endo-dontics 2003 29 324ndash333

68 Waterhouse PJ Whitworth JM Nunn JH Development of amethod to detect and quantify Prostaglandin E2 in pulpalblood from cariously exposed vital primary molar teethInternational Endodontic Journal 1999 32 381ndash387

69 Waterhouse PJ Nunn JH Whitworth JM Prostaglandin E2and treatment outcome in pulp therapy of primary molarswith carious exposures International Journal of PaediatricDentistry 2002 12 116ndash123

70 Tickle M Milsom K King D Kearney-Mitchell P BlinkhornA The fate of the carious primary teeth of children whoregularly attend the general dental service British DentalJournal 2002 192 219ndash223

71 Milsom K Tickle M King D Does the dental professionknow how to care for the primary dentition British DentalJournal 2003 195 301ndash303

72 Pendlebury ME Horner K Eaton KA (eds) Selection Criteriafor Dental Radiography 2nd edn London Faculty of GeneralDental Practitioners (UK) The Royal College of Surgeons ofEngland 2004

73 Fuks AB Bimstein E Kelin H Assessment of a 2 percentbuffered glutaraldehyde solution in pulpotomized primaryteeth of school children a preliminary report Journal ofPedodontics 1986 10 323ndash330

74 Mack RB Dean JA Electrosurgical pulpotomy a retrospec-tive human study Journal of Dentistry for Children 1993 60107ndash114

75 Agamy HA Bakry NS Mounir MMF Avery DR Comparisonof mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth PediatricDentistry 2004 26 302ndash309

76 Elliot RD Roberts MW Burkes J Phillips C Evaluation ofthe carbon dioxide laser on vital human primary pulp tissuePaediatric Dentistry 1999 21 327ndash331

77 Al-Zayer MA Straffon LH Feigal RJ Welch KB Indirectpulp treatment of primary posterior teeth a retrospectivestudy Pediatric Dentistry 2003 25 29ndash36

78 Hansen HP Ravn JJ Ulrich D Vital pulpotomy in primarymolars A clinical and histological investigation of the effectof zinc-oxide eugenol cement and Ledermix ScandinavialJournal of Dental Research 1971 79 13ndash23

Development of a pulp therapy protocol

201

copy 2006 BSPD and IAPD

paediatric dentists comprising consultants specialistregistrars university academics and a staff grade wasformed in order to establish a consensus decision on themanagement of extensively carious primary molar teeth

A traditional narrative literature review was com-pleted (Part I of this publication) and primaryresearch papers for each of the possible alternativesto formocresol were identified Where possible ran-domised control trials were chosen to evaluate clinicaland radiographic success for each medicament [59ndash65] Histological animal studies were identified toenable comparison between the cytological andtoxicological effects of different medicaments andtechniques [6667] Each clinician in the specialistgroup was asked to critically appraise their allocatedpapers and to present their findings at a lsquobrainstormingrsquosession

Following appraisal of the selected publicationsthe group discussed the ideal properties of a pulptherapy agent and tabulated the key findings of thereview (Table 1) It was felt that in light of therecent IARC findings it was necessary to implementthe chosen alternatives as soon as possible whilstalso considering techniques which may be possiblein the future

For inclusion in the protocol it was necessary fora technique or medicament to have a sufficientevidence base ideally human trials for clinical efficacyand to be economical in order to justify its routineuse within an NHS teaching hospital There shouldalso be little immediate financial outlay or trainingimplications to allow rapid introduction of theprotocol

On this basis ferric sulphate (AstringedentUltradent Products Inc South Jordan UT USA)was chosen for use in the vital primary molar pulpot-omy Although concerns were expressed that thisagent may mask underlying pulp pathosis it was feltthat it was clinically successful operator- and patient-friendly and a financially viable medicament Mineraltrioxide aggregate (MTA Pro Root Dentsply TulsaDental Weybridge UK) will also be an option for staff-performed pulpotomies and perhaps introduced intothe undergraduate arena in the future

A working draft of the protocol was produced andcirculated to enter into the lsquoiterativersquo process ofreview The draft protocol consisted of a flow chart toassist clinicians in their treatment planning combinedwith a key points document to offer further infor-mation and to standardise data for future research

Table 1 Comparison of alternatives to formocresol for pulp therapy (MTA) mineral trioxide aggregate (IPT) indirect pulp therapyand (BMP) bone morphogenic protein

MaterialClinical success(example cited)

Human clinical studies

Tested against

formocresol

Operator ease of

usePatient

acceptabilityCost of

techniqueEffect upon

pulp cell

Glutaraldehyde 82 over 25 months Yes Yes Good Good Low DevitalisationFuks et al [73]

Electrosurgery 99middot4 over 70 months No No Poor Poor Medium DevitalisationMack and Dean [74]

Ferric sulphate 92 over 4 years Yes Yes Good Good Low PreservationIbrecevic [60]

Calcium hydroxide 77middot1 over 22middot5 months Yes Yes Good Good Low PreservationWaterhouse [50]

MTA 100 over one year (grey) Yes No Fair Good High Preservation84middot2 over one year (white)Agamy et al [75]

Lasers 100 over 90 days Yes Yes Poor Poor High PreservationElliot et al [76]

IPT 95 over 2ndash72 weeks Yes Yes Good Good Low RemineralisationAl Zayer et al [77]

BMP No studies No No Unknown Unknown Unknown Remineralisation

Collagen No studies No No Unknown Unknown Unknown Remineralisation

Pulpectomy 91 over 36 months Yes Yes Poor Poor Low ExtirpationCasas and Kenny [61]

Ledermix 79 over 42 month Yes No Good Good Low PreservationHansen et al [78]

202

C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

and audit Each draft version was then circulated forcomment a further three times This resulted in theworking protocol (Fig 1) To facilitate future auditof the protocol every time pulp therapy is per-formed within the Department a stamp will beused to record standardised information in thepatientrsquos notes for example the time taken toachieve haemostasis and the number of applicationsof ferric sulphate required The information will alsobe recorded in a lsquopulp therapy bookrsquo

Implementation of the protocol

Undergraduate dental students were informed ofchanges in protocol via information uploaded withinthe University Virtual Learning Environment Inaddition a lecture was given to all third-year studentsprior to their initial clinical sessions within paedi-atric dentistry and an existing seminar was revisedto include an update on pulp therapy in the primarydentition The same information was supplied to allteachers of paediatric dentistry within the school andin outreach clinics It is expected that further modifi-cations to the teaching programme will be made aspulp therapy techniques are developed and audited

The working protocol and key points documentwere circulated to all staff working within thedepartment Discussion of these documents wasincorporated into the junior staff induction programmeNursing staff were also informed of the new techniquesand proposed local protocols via the senior nurseAreas for future staff training were identified at theteam meeting and hands-on training for specialiststaff has been arranged for the near future

Discussion

Following the recent IARC press release [51] theuse of formocresol in paediatric dentistry is nolonger recommended and clinicians must adoptalternative evidence-based procedures The authorsacknowledge that the evidence for some of thealternatives to formocresol is weak However theIARC statement demands a change to currentpractice and an urgent review of the alternatives inorder to develop an interim protocol It is hoped thatthis protocol will add to the debate and enable thecollection of standardised data which will in turnlead to a more evidence-based guideline in the future

The importance of careful patient and tooth selectionwhen considering provision of a pulp therapy cannot

be overemphasised In order for vital pulp therapyto be successful the patient must be sufficientlycompliant to allow adequate moisture control ideallywith rubber dam placement and the tooth must beradiographically free of pathology and restorablewith a bonded restoration or preformed metal crownin order to provide an effective seal

Despite careful initial assessment diagnosis ofpulpal status may be difficult For example once anirreversibly inflamed coronal pulp has been ampu-tated the health of the radicular pulp is assessed onan empirical basis ie how readily the pulp stumpbleeds As yet we have no scientific clinical methodof determining pulpal status prior to treatmentalthough there has been some work to investigatecorrelations between the presence of certain inflam-matory mediators and clinical outcome [6869]

Presently in Newcastle the treatment of choicefor nonvital primary molars is extraction since thereis little evidence of an alternative medicament whichis as effective as formocresol and which exhibitsminimal technique sensitivity Pulpectomy remainsan option for the future but staff training will berequired before the technique can be introduced inthe clinical setting and taught at undergraduate levelThe management of the partially vital primary molarmerits further research and discussion since the evid-ence is scant for the use of Ledermixtrade (BlackwellSupplies Ltd Gillingham UK) in such teeth

In order to justify its use within an NHS teachinghospital a medicament must be effective from botha clinical and an economical perspective Mineraltrioxide aggregate has been previously excluded insome centres on the basis of its expense but researchwould suggest that MTA does have a role to playin the treatment of carefully selected primary molarvital pulpotomies and that its cost is comparable tothat of ferric sulphate

Ferric sulphate appears to be as effective in vitalpulpotomies as formocresol and there is no evid-ence to date to suggest any adverse effects of thismedicament As such within the protocol it waschosen as the treatment of choice for vital pulpot-omies Further research and audit is required tobuild on the existing evidence base for ferric sulphatein particular the authors would welcome morelong-term randomised clinical trials

It has been suggested that the careful monitoringof primary teeth with extensive caries is a reason-able treatment option when combined with a thoroughpreventive regimen [7071] The authors suggest that

Development of a pulp therapy protocol

203

copy 2006 BSPD and IAPD

Fig 1 Primary molar protocol (MH) medical history (LA) local anaesthesia (RA) relative analgesia (GA) general anaesthesia (ADJ) amelodentinaljunction (GIC) glass ionomer cement (ZnOE) zinc oxide eugenol cement (PFMC) preformed metal crown and (GDP) general dental practitioner

204

C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

monitoring may be appropriate but only for patientswho are unable to accept operative treatment andwhere the tooth is asymptomatic and clinically andradiographically free of pathology It is advisablethat this decision is made with the consent of a fullyinformed parent because of the potential risk ofdamage to the permanent successor Monitoring isnot an option for patients to whom infection posesa significant risk for example those with leukaemiaor congenital heart defects

Radiographic review

Regular radiographic monitoring of treated teethis advocated to assist in the assessment of primarymolar and permanent successor teeth A radiographtaken after treatment would enable detection ofrecurrent caries a failing coronal restoration peri-apical or furcal radiolucencies internal or externalroot resorption failure of eruption of the permanentsuccessor tooth along its expected path and patho-sis with or without concomitant clinical symptomswhich may damage or deflect the permanent toothgerm [50]

Although the literature relating to the frequencyof radiographing pulpotomised teeth is scant theFaculty of General Dental Practitioners [72] clearlyoutlines selection criteria for radiographic screeningaccording to caries risk status These guidelines sug-gest that bitewing radiographs should be taken on a6-monthly basis for children identified as high cariesrisk and on an annual basis for those classified asmoderate risk The authors would suggest that a

vertical bitewing radiograph could be taken as part ofthis radiographic review because this would enablea review after pulp therapy without an increase inradiation dose

Conclusion

Following a review of the current literature a workingclinical protocol for pulp therapy techniques in theextensively carious primary molar has been developedThis protocol has been implemented at the under-graduate and postgraduate levels and has helped toidentify areas where further staff training is requiredIt is expected that the clinical protocol will evolve asfurther evidence comes to light

Acknowledgements

The authors would like to thank the following fortheir significant contributions to the developmentof the protocol Dr Andrew Shaw Dr Ben ColeDr Anne Maguire Dr Loraine Lowry Mrs VirginiaHind and Mrs Solape Adeboye

References

1 Buckley JP The chemistry of pulp decomposition with arational treatment for this condition and its sequelae

AmericanDental Journal

1904

3

764ndash7712 Sweet CA Jr Procedure for treatment of exposed and pulpless

deciduous teeth

Journal of the American Dental Association

1930

17

1150ndash11533 Roslashlling I Thylstrup A A 3-year clinical follow-up study of

pulpotomised primary molars treated with the formocresoltechnique

Scandinavian Journal of Dental Research

1975

83

47ndash534 Magnusson BO Therapeutic pulpotomies in primary molars

with the formocresol technique A clinical and histologicalfollow-up

Acta Odontologica Scandinavica

1978

36

157ndash165

5 Mejagravere I Pulpotomy of primary molars with coronal or totalpulpitis using formocresol technique

Scandinavian Journalof Dental Research

1979

87

208ndash2166 Magnusson BO Pulpotomy in primary molars long term

clinical and histological evaluation

International EndodonticJournal

1980

13

143ndash1557 Verco PJW Allen KR Formocresol pulpotomies in primary

teeth

Journal of the International Association of Dentistryfor Children

1984

15

51ndash558 Hicks MJ Barr ES Flaitz CM Formocresol pulpotomies in

primary molars a radiographic study in a paediatric dentistrypractice

Journal of Pedodontics

1986

10

331ndash3399 Morawa AP Straffon LH Han SS Copron RE Clinical

evaluation of pulpotomies using dilute formocresol

ASDCJournal of Dentistry for Children

1975

42

360ndash36310 Fuks AB Bimstein E Clinical evaluation of diluted formocresol

What this paper adds

bull This paper highlights the stages in the development ofa local clinical protocol

bull The protocol consisted of a flow chart to assist cliniciansin their treatment planning combined with a key pointsdocument to offer further information and to standardisedata for future research and audit

Why this paper is important for paediatric dentists

bull Prior to the use of any clinical intervention the evidencebase behind it requires consideration

bull In order to justify its use within any clinical setting (beit primary dental care or an NHS teaching hospital)a medicament or technique must be effective from aclinical and economical perspective

bull Ferric sulphate was chosen within our protocol as thetreatment of choice for vital pulpotomies as it appearsto be as effective as fromocresol in vital pulpotomies todate and there is no evidence to suggest any adverseeffects from this medicament

Development of a pulp therapy protocol

205

copy 2006 BSPD and IAPD

pulpotomies in primary teeth of schoolchildren

PediatricDentistry

1981

3

321ndash32411 Garcia-Godoy F Direct pulp capping and partial pulpotomy

with diluted formocresol in primary molars

Acta de OdontologicaPediatrica

1984

5

57ndash6112 Prakash C Chandra S Jaiswal JN Formocresol and glutaralde-

hyde pulpotomies in primary teeth

Journal of Pedodontics

1989

13

314ndash32213 Formaldehyde Panel

Report of the Federal Panel on Formaldehyde

Research Triangle Park NC National Toxicology Program 1980

14 Lewis BB Chestner SB Formaldehyde in dentistry a reviewof mutagenic and carcinogenic potential

Journal of the AmericanDental Association

1981

103

429ndash43415 Block RM Lewis RD Hirsch J Coffey J Langeland K Systemic

distribution of

14

C-labeled paraformaldehyde incorporatedwithin formocresol following pulpotomies in dogs

Journal ofEndodontics

1983

9

176ndash18916 Waterhouse PJ Formocresol and alternative primary molar

pulpotomy medicaments a review

Endodontics and DentalTraumatology

1995

11

157ndash16217 Judd PL Kenny DJ Formocresol concerns a review

Journalof the Canadian Dental Association

1987

5

401ndash40418 Wilkins RJ McLeod HD Formaldehyde induced DNA-protein

cross-links in

Escherichia coli

Mutation Research

1976

36

11ndash16

19 Takahashi K Morita T Kawazoe Y Mutagenic characteristicsof formaldehyde on bacterial systems

Mutation Research

1985

156

153ndash16120 Kaplan WD Formaldehyde as a mutagen in Drosophila

Science

1948

108

4321 Soffritti M Belpoggi F Lambertin L Lauriola M Padovani M

Maltoni C Results of long-term experimental studies on thecarcinogenicity of formaldehyde and acetaldehyde in rats

Annals of the New York Academy of Sciences

2002

982

87ndash105

22 Swenberg JA Kerns WD Mitchell RI Gralla EJ Pavkov KLInduction of squamous cell carcinomas of the rat nasalcavity by inhalation exposure to formaldehyde vapour

CancerResearch

1980

40

3398ndash340223 Mueller R Raabe G Schumann D Leukoplakia induced by

repeated deposition of formalin in rabbit oral mucosa longterm experiments in a new lsquooral tankrsquo

Experimental Pathology

1978

16

36ndash4224 Bolt HM Experimental toxicology of formaldehyde

Journalof Cancer Research and Clinical Oncology

1987

113

305ndash30925 Bernstein RS Stayner LT Elliot LI Kimbrough RK Inhala-

tion exposure to formaldehyde an overview of its toxicologyepidemiology monitoring and control

American IndustrialHygiene Association Journal

1984

45

778ndash78526 Goldmacher VS Thilly WD Formaldehyde is mutagenic for

cultured human cells

Mutation Research

1983

116

417ndash422

27 He JL Jin LF Jin HY Detection of cytogenic effects inperipheral lymphocytes of students exposed to formaldehydewith cytokinesis-blocked micronucleus assay

Biomedical andEnvironmental Sciences

1998

11

87ndash9228 Bauchinger M Schmid E Cytogenic effects in lymphocytes

of formaldehyde workers of a paper factory

MutationResearch

1985

158

195ndash19929 Kitaeva LV Mikheeva EA Shelomova LF Shvartsman PI

Genotoxic effect of formaldehyde in somatic human cells

invivo

[in Russian]

Genetika

1996

32

1287ndash129030 Suruda A Schulte P Boeniger M

et al

Cytogenetic effectsof formaldehyde exposure in students of mortuary science

Cancer Epidemiology Biomarkers and Prevention

1993

2

453ndash460

31 Shaham J Bomstein Y Meltzer A Ribak J DNA-proteincrosslinks a biomarker of exposure to formaldehyde ndash

invitro

and

in vivo

studies

Carcinogenesis

1996

17

121ndash12532 Shaham J Bomstein Y Meltzer A Kaufman Z Palma E

Ribak J DNA-protein crosslinks and sister chromatidexchanges as biomarkers of exposure to formaldehyde

Inter-national Journal of Occupational Medicine and EnvironmentalHealth

1997

3

95ndash10433 Yager JW Cohn KL Spear RC Fisher JM Morse L Sister-

chromatid exchanges in lymphocytes of anatomy studentsexposed to formaldehyde embalming solution

MutationResearch

1986

174

135ndash13934 Shaham J Gurvich R Kaufman Z Sister chromatid exchange

in pathology staff occupationally exposed to formaldehyde

Mutation Research

2002

15

115ndash12335 Bonassi S Hagmar L Stromberg U

et al

Chromosomal aber-rations in lymphocytes predict human cancer independentlyof exposure to carcinogens European Study Group onCytogenetic Biomarkers and Health

Cancer Research

2000

60

1619ndash162536 Tucker JD Preston RJ Chromosome aberrations micronuclei

aneuploidy sister chromatid exchanges and cancer riskassessment

Mutation Research

1996

365

147ndash15937 Hauptmann M Lubin JH Stewart PA Hayes RB Blair A

Mortality from lymphohematopoietic malignancies amongworkers in formaldehyde industries

Journal of the NationalCancer Institute

2003

95

1615ndash162338 Pinkerton L Hein M Stayner L Mortality among a cohort

of garment workers exposed to formaldehyde an update

Occupational and Environmental Medicine

2004

61

193ndash200

39 Coggon D Harris EC Poole J

et al

Extended follow-up ofa cohort of British chemical workers exposed to formaldehyde

Journal of the National Cancer Institute

2003

21

1608ndash161440 Bertazzi PA Pesatori AC Radice L Zocchetti C Vai T

Exposure to formaldehyde and cancer mortality in a cohortof workers producing resins

Scandinavian Journal of WorkEnvironment and Health

1986

12

461ndash46841 Hauptmann M Lubin JH Stewart PA Hayes RB Blair A

Mortality from solid cancers among workers in formaldehydeindustries

American Journal of Epidemiology

2004

159

1117ndash1130

42 Blair A Stewart P OrsquoBerg M

et al

Mortality among indus-trial workers exposed to formaldehyde

Journal of theNational Cancer Institute

1986

76 1071ndash108443 Gardner MJ Pannett B Winter PD Cruddas AM A cohort

study of workers exposed to formaldehyde in the Britishchemical industry an update British Journal of IndustrialMedicine 1993 50 827ndash834

44 Hayes RB Blair A Stewart PA Herrick RF Mahar HMortality of US embalmers and funeral directors AmericanJournal of Industrial Medicine 1990 18 641ndash652

45 Collins JJ Esmen NA Hall TA A review and meta-analysisof formaldehyde exposure and pancreatic cancer AmericanJournal of Industrial Medicine 2001 39 336ndash345

46 Pashley EL Nelson R Pashley DH Systemic distribution of14C-formaldehyde with formocresol-treated pulpotomy sitesJournal of Dental Research 1980 59 603ndash608

47 Myers DR Shoaf HK Dirksen TR Distribution of 14C-formaldehyde after pulpotomy with formocresol Journal ofthe American Dental Association 1978 96 805ndash813

48 Zarzar PA Rosenblatt A Takahashi CS Takeuchi PL Costa

206 C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

LA Jr Formocresol mutagenicity following primary toothpulp therapy an in vivo study Journal of Dentistry 2003 31479ndash485

49 Messer LB Cline JT Korf NW Long-term effects of primarymolar pulpotomies on succedaneous bicuspids Journal ofDental Research 1980 29 116ndash123

50 Waterhouse PJ A comparison of the relative efficacy offormocresol versus calcium hydroxide as vital pulp therapyagents in primary molars PhD Thesis Newcastle upon TyneUniversity of Newcastle upon Tyne 2000

51 International Agency for Research on Cancer Press releaseno 153 15 June 2004 [WWW document] URL httpwwwiarcfrpagerootPRELEASESpr153ahtml

52 National Pathways Association NPA definition of a pathwayof care NPA Newsletter 1998 Spring 2

53 Currie L Harvey G The Origins and Uses of Care Pathwaysin the USA Australia and the United Kingdom Report No 15London RCN Institute Oxford Centre Royal College ofNursing 1997

54 Hale C Issues in the evaluation of multidisciplinary pathwaysof care In Wilson J (ed) Integrated Care Management The Pathto Success Oxford Butterworth-Heinemann 1987 281ndash296

55 de Luc K Care pathways an evaluation of their effectivenessJournal of Advanced Nursing 2000 32 485ndash496

56 Currie L Care pathways development and implementationNursing Standard 1998 12 35ndash38

57 Goel V Decision analysis applications and limitationsCanadian Medical Association Journal 1992 147 413ndash417

58 Richardson WS Detsky AS Usersrsquo guides to the medicalliterature VII How to use a clinical decision analysis Arethe results of the study valid Journal of the American MedicalAssociation 1995 273 1292ndash1295

59 Ibricevic H Al-Jame Q Ferric sulfate as pulpotomy agent inprimary teeth twenty month clinical follow-up PediatricDentistry 2000 24 269ndash272

60 Ibricevic H Al-Jame Q Ferric sulphate and formocresol inpulpotomy of primary molars long term follow-up studyEuropean Journal of Paediatric Dentistry 2003 4 28ndash32

61 Casas MJ Kenny DJ Johnston DH Judd PJ Long-term out-comes of primary molar ferric sulfate pulpotomy and rootcanal therapy Pediatric Dentistry 2004 26 44ndash48

62 Papagiannoulis L Clinical studies on ferric sulphate as apulpotomy medicament in primary teeth European Journalof Paediatric Dentistry 2002 3 126ndash132

63 Salako N Joseph B Ritwik P Salonen J John P Junaid TAComparison of bioactive glass mineral trioxide aggregateferric sulphate and formocresol as pulpotomy agents in ratmolar Dental Traumatology 2003 19 314ndash320

64 Casas MJ Kenny DJ Johnston DH Judd PL Layug MAOutcomes of vital primary incisor ferric sulphate pulpotomyand root canal therapy Journal of the Canadian Dental Asso-ciation 2004 70 34ndash38

65 Casas MJ Layug MA Kenny DJ Johnston DH Judd PLTwo-year outcomes of primary molar ferric sulphate pulpot-omy and root canal therapy Pediatric Dentistry 2003 25 97ndash102

66 Cleaton-Jones P Duggal M Parak M Williams S Setze SFerric sulphate and formocresol pulpotomies in baboonprimary molars histological responses European Journal ofPaediatric Dentistry 2002 3 121ndash125

67 Dominguez MS Witherspoon DE Gutmann JL OppermanLA Histological and scanning electron microscopy assess-ment of various vital pulp-therapy materials Journal of Endo-dontics 2003 29 324ndash333

68 Waterhouse PJ Whitworth JM Nunn JH Development of amethod to detect and quantify Prostaglandin E2 in pulpalblood from cariously exposed vital primary molar teethInternational Endodontic Journal 1999 32 381ndash387

69 Waterhouse PJ Nunn JH Whitworth JM Prostaglandin E2and treatment outcome in pulp therapy of primary molarswith carious exposures International Journal of PaediatricDentistry 2002 12 116ndash123

70 Tickle M Milsom K King D Kearney-Mitchell P BlinkhornA The fate of the carious primary teeth of children whoregularly attend the general dental service British DentalJournal 2002 192 219ndash223

71 Milsom K Tickle M King D Does the dental professionknow how to care for the primary dentition British DentalJournal 2003 195 301ndash303

72 Pendlebury ME Horner K Eaton KA (eds) Selection Criteriafor Dental Radiography 2nd edn London Faculty of GeneralDental Practitioners (UK) The Royal College of Surgeons ofEngland 2004

73 Fuks AB Bimstein E Kelin H Assessment of a 2 percentbuffered glutaraldehyde solution in pulpotomized primaryteeth of school children a preliminary report Journal ofPedodontics 1986 10 323ndash330

74 Mack RB Dean JA Electrosurgical pulpotomy a retrospec-tive human study Journal of Dentistry for Children 1993 60107ndash114

75 Agamy HA Bakry NS Mounir MMF Avery DR Comparisonof mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth PediatricDentistry 2004 26 302ndash309

76 Elliot RD Roberts MW Burkes J Phillips C Evaluation ofthe carbon dioxide laser on vital human primary pulp tissuePaediatric Dentistry 1999 21 327ndash331

77 Al-Zayer MA Straffon LH Feigal RJ Welch KB Indirectpulp treatment of primary posterior teeth a retrospectivestudy Pediatric Dentistry 2003 25 29ndash36

78 Hansen HP Ravn JJ Ulrich D Vital pulpotomy in primarymolars A clinical and histological investigation of the effectof zinc-oxide eugenol cement and Ledermix ScandinavialJournal of Dental Research 1971 79 13ndash23

202

C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

and audit Each draft version was then circulated forcomment a further three times This resulted in theworking protocol (Fig 1) To facilitate future auditof the protocol every time pulp therapy is per-formed within the Department a stamp will beused to record standardised information in thepatientrsquos notes for example the time taken toachieve haemostasis and the number of applicationsof ferric sulphate required The information will alsobe recorded in a lsquopulp therapy bookrsquo

Implementation of the protocol

Undergraduate dental students were informed ofchanges in protocol via information uploaded withinthe University Virtual Learning Environment Inaddition a lecture was given to all third-year studentsprior to their initial clinical sessions within paedi-atric dentistry and an existing seminar was revisedto include an update on pulp therapy in the primarydentition The same information was supplied to allteachers of paediatric dentistry within the school andin outreach clinics It is expected that further modifi-cations to the teaching programme will be made aspulp therapy techniques are developed and audited

The working protocol and key points documentwere circulated to all staff working within thedepartment Discussion of these documents wasincorporated into the junior staff induction programmeNursing staff were also informed of the new techniquesand proposed local protocols via the senior nurseAreas for future staff training were identified at theteam meeting and hands-on training for specialiststaff has been arranged for the near future

Discussion

Following the recent IARC press release [51] theuse of formocresol in paediatric dentistry is nolonger recommended and clinicians must adoptalternative evidence-based procedures The authorsacknowledge that the evidence for some of thealternatives to formocresol is weak However theIARC statement demands a change to currentpractice and an urgent review of the alternatives inorder to develop an interim protocol It is hoped thatthis protocol will add to the debate and enable thecollection of standardised data which will in turnlead to a more evidence-based guideline in the future

The importance of careful patient and tooth selectionwhen considering provision of a pulp therapy cannot

be overemphasised In order for vital pulp therapyto be successful the patient must be sufficientlycompliant to allow adequate moisture control ideallywith rubber dam placement and the tooth must beradiographically free of pathology and restorablewith a bonded restoration or preformed metal crownin order to provide an effective seal

Despite careful initial assessment diagnosis ofpulpal status may be difficult For example once anirreversibly inflamed coronal pulp has been ampu-tated the health of the radicular pulp is assessed onan empirical basis ie how readily the pulp stumpbleeds As yet we have no scientific clinical methodof determining pulpal status prior to treatmentalthough there has been some work to investigatecorrelations between the presence of certain inflam-matory mediators and clinical outcome [6869]

Presently in Newcastle the treatment of choicefor nonvital primary molars is extraction since thereis little evidence of an alternative medicament whichis as effective as formocresol and which exhibitsminimal technique sensitivity Pulpectomy remainsan option for the future but staff training will berequired before the technique can be introduced inthe clinical setting and taught at undergraduate levelThe management of the partially vital primary molarmerits further research and discussion since the evid-ence is scant for the use of Ledermixtrade (BlackwellSupplies Ltd Gillingham UK) in such teeth

In order to justify its use within an NHS teachinghospital a medicament must be effective from botha clinical and an economical perspective Mineraltrioxide aggregate has been previously excluded insome centres on the basis of its expense but researchwould suggest that MTA does have a role to playin the treatment of carefully selected primary molarvital pulpotomies and that its cost is comparable tothat of ferric sulphate

Ferric sulphate appears to be as effective in vitalpulpotomies as formocresol and there is no evid-ence to date to suggest any adverse effects of thismedicament As such within the protocol it waschosen as the treatment of choice for vital pulpot-omies Further research and audit is required tobuild on the existing evidence base for ferric sulphatein particular the authors would welcome morelong-term randomised clinical trials

It has been suggested that the careful monitoringof primary teeth with extensive caries is a reason-able treatment option when combined with a thoroughpreventive regimen [7071] The authors suggest that

Development of a pulp therapy protocol

203

copy 2006 BSPD and IAPD

Fig 1 Primary molar protocol (MH) medical history (LA) local anaesthesia (RA) relative analgesia (GA) general anaesthesia (ADJ) amelodentinaljunction (GIC) glass ionomer cement (ZnOE) zinc oxide eugenol cement (PFMC) preformed metal crown and (GDP) general dental practitioner

204

C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

monitoring may be appropriate but only for patientswho are unable to accept operative treatment andwhere the tooth is asymptomatic and clinically andradiographically free of pathology It is advisablethat this decision is made with the consent of a fullyinformed parent because of the potential risk ofdamage to the permanent successor Monitoring isnot an option for patients to whom infection posesa significant risk for example those with leukaemiaor congenital heart defects

Radiographic review

Regular radiographic monitoring of treated teethis advocated to assist in the assessment of primarymolar and permanent successor teeth A radiographtaken after treatment would enable detection ofrecurrent caries a failing coronal restoration peri-apical or furcal radiolucencies internal or externalroot resorption failure of eruption of the permanentsuccessor tooth along its expected path and patho-sis with or without concomitant clinical symptomswhich may damage or deflect the permanent toothgerm [50]

Although the literature relating to the frequencyof radiographing pulpotomised teeth is scant theFaculty of General Dental Practitioners [72] clearlyoutlines selection criteria for radiographic screeningaccording to caries risk status These guidelines sug-gest that bitewing radiographs should be taken on a6-monthly basis for children identified as high cariesrisk and on an annual basis for those classified asmoderate risk The authors would suggest that a

vertical bitewing radiograph could be taken as part ofthis radiographic review because this would enablea review after pulp therapy without an increase inradiation dose

Conclusion

Following a review of the current literature a workingclinical protocol for pulp therapy techniques in theextensively carious primary molar has been developedThis protocol has been implemented at the under-graduate and postgraduate levels and has helped toidentify areas where further staff training is requiredIt is expected that the clinical protocol will evolve asfurther evidence comes to light

Acknowledgements

The authors would like to thank the following fortheir significant contributions to the developmentof the protocol Dr Andrew Shaw Dr Ben ColeDr Anne Maguire Dr Loraine Lowry Mrs VirginiaHind and Mrs Solape Adeboye

References

1 Buckley JP The chemistry of pulp decomposition with arational treatment for this condition and its sequelae

AmericanDental Journal

1904

3

764ndash7712 Sweet CA Jr Procedure for treatment of exposed and pulpless

deciduous teeth

Journal of the American Dental Association

1930

17

1150ndash11533 Roslashlling I Thylstrup A A 3-year clinical follow-up study of

pulpotomised primary molars treated with the formocresoltechnique

Scandinavian Journal of Dental Research

1975

83

47ndash534 Magnusson BO Therapeutic pulpotomies in primary molars

with the formocresol technique A clinical and histologicalfollow-up

Acta Odontologica Scandinavica

1978

36

157ndash165

5 Mejagravere I Pulpotomy of primary molars with coronal or totalpulpitis using formocresol technique

Scandinavian Journalof Dental Research

1979

87

208ndash2166 Magnusson BO Pulpotomy in primary molars long term

clinical and histological evaluation

International EndodonticJournal

1980

13

143ndash1557 Verco PJW Allen KR Formocresol pulpotomies in primary

teeth

Journal of the International Association of Dentistryfor Children

1984

15

51ndash558 Hicks MJ Barr ES Flaitz CM Formocresol pulpotomies in

primary molars a radiographic study in a paediatric dentistrypractice

Journal of Pedodontics

1986

10

331ndash3399 Morawa AP Straffon LH Han SS Copron RE Clinical

evaluation of pulpotomies using dilute formocresol

ASDCJournal of Dentistry for Children

1975

42

360ndash36310 Fuks AB Bimstein E Clinical evaluation of diluted formocresol

What this paper adds

bull This paper highlights the stages in the development ofa local clinical protocol

bull The protocol consisted of a flow chart to assist cliniciansin their treatment planning combined with a key pointsdocument to offer further information and to standardisedata for future research and audit

Why this paper is important for paediatric dentists

bull Prior to the use of any clinical intervention the evidencebase behind it requires consideration

bull In order to justify its use within any clinical setting (beit primary dental care or an NHS teaching hospital)a medicament or technique must be effective from aclinical and economical perspective

bull Ferric sulphate was chosen within our protocol as thetreatment of choice for vital pulpotomies as it appearsto be as effective as fromocresol in vital pulpotomies todate and there is no evidence to suggest any adverseeffects from this medicament

Development of a pulp therapy protocol

205

copy 2006 BSPD and IAPD

pulpotomies in primary teeth of schoolchildren

PediatricDentistry

1981

3

321ndash32411 Garcia-Godoy F Direct pulp capping and partial pulpotomy

with diluted formocresol in primary molars

Acta de OdontologicaPediatrica

1984

5

57ndash6112 Prakash C Chandra S Jaiswal JN Formocresol and glutaralde-

hyde pulpotomies in primary teeth

Journal of Pedodontics

1989

13

314ndash32213 Formaldehyde Panel

Report of the Federal Panel on Formaldehyde

Research Triangle Park NC National Toxicology Program 1980

14 Lewis BB Chestner SB Formaldehyde in dentistry a reviewof mutagenic and carcinogenic potential

Journal of the AmericanDental Association

1981

103

429ndash43415 Block RM Lewis RD Hirsch J Coffey J Langeland K Systemic

distribution of

14

C-labeled paraformaldehyde incorporatedwithin formocresol following pulpotomies in dogs

Journal ofEndodontics

1983

9

176ndash18916 Waterhouse PJ Formocresol and alternative primary molar

pulpotomy medicaments a review

Endodontics and DentalTraumatology

1995

11

157ndash16217 Judd PL Kenny DJ Formocresol concerns a review

Journalof the Canadian Dental Association

1987

5

401ndash40418 Wilkins RJ McLeod HD Formaldehyde induced DNA-protein

cross-links in

Escherichia coli

Mutation Research

1976

36

11ndash16

19 Takahashi K Morita T Kawazoe Y Mutagenic characteristicsof formaldehyde on bacterial systems

Mutation Research

1985

156

153ndash16120 Kaplan WD Formaldehyde as a mutagen in Drosophila

Science

1948

108

4321 Soffritti M Belpoggi F Lambertin L Lauriola M Padovani M

Maltoni C Results of long-term experimental studies on thecarcinogenicity of formaldehyde and acetaldehyde in rats

Annals of the New York Academy of Sciences

2002

982

87ndash105

22 Swenberg JA Kerns WD Mitchell RI Gralla EJ Pavkov KLInduction of squamous cell carcinomas of the rat nasalcavity by inhalation exposure to formaldehyde vapour

CancerResearch

1980

40

3398ndash340223 Mueller R Raabe G Schumann D Leukoplakia induced by

repeated deposition of formalin in rabbit oral mucosa longterm experiments in a new lsquooral tankrsquo

Experimental Pathology

1978

16

36ndash4224 Bolt HM Experimental toxicology of formaldehyde

Journalof Cancer Research and Clinical Oncology

1987

113

305ndash30925 Bernstein RS Stayner LT Elliot LI Kimbrough RK Inhala-

tion exposure to formaldehyde an overview of its toxicologyepidemiology monitoring and control

American IndustrialHygiene Association Journal

1984

45

778ndash78526 Goldmacher VS Thilly WD Formaldehyde is mutagenic for

cultured human cells

Mutation Research

1983

116

417ndash422

27 He JL Jin LF Jin HY Detection of cytogenic effects inperipheral lymphocytes of students exposed to formaldehydewith cytokinesis-blocked micronucleus assay

Biomedical andEnvironmental Sciences

1998

11

87ndash9228 Bauchinger M Schmid E Cytogenic effects in lymphocytes

of formaldehyde workers of a paper factory

MutationResearch

1985

158

195ndash19929 Kitaeva LV Mikheeva EA Shelomova LF Shvartsman PI

Genotoxic effect of formaldehyde in somatic human cells

invivo

[in Russian]

Genetika

1996

32

1287ndash129030 Suruda A Schulte P Boeniger M

et al

Cytogenetic effectsof formaldehyde exposure in students of mortuary science

Cancer Epidemiology Biomarkers and Prevention

1993

2

453ndash460

31 Shaham J Bomstein Y Meltzer A Ribak J DNA-proteincrosslinks a biomarker of exposure to formaldehyde ndash

invitro

and

in vivo

studies

Carcinogenesis

1996

17

121ndash12532 Shaham J Bomstein Y Meltzer A Kaufman Z Palma E

Ribak J DNA-protein crosslinks and sister chromatidexchanges as biomarkers of exposure to formaldehyde

Inter-national Journal of Occupational Medicine and EnvironmentalHealth

1997

3

95ndash10433 Yager JW Cohn KL Spear RC Fisher JM Morse L Sister-

chromatid exchanges in lymphocytes of anatomy studentsexposed to formaldehyde embalming solution

MutationResearch

1986

174

135ndash13934 Shaham J Gurvich R Kaufman Z Sister chromatid exchange

in pathology staff occupationally exposed to formaldehyde

Mutation Research

2002

15

115ndash12335 Bonassi S Hagmar L Stromberg U

et al

Chromosomal aber-rations in lymphocytes predict human cancer independentlyof exposure to carcinogens European Study Group onCytogenetic Biomarkers and Health

Cancer Research

2000

60

1619ndash162536 Tucker JD Preston RJ Chromosome aberrations micronuclei

aneuploidy sister chromatid exchanges and cancer riskassessment

Mutation Research

1996

365

147ndash15937 Hauptmann M Lubin JH Stewart PA Hayes RB Blair A

Mortality from lymphohematopoietic malignancies amongworkers in formaldehyde industries

Journal of the NationalCancer Institute

2003

95

1615ndash162338 Pinkerton L Hein M Stayner L Mortality among a cohort

of garment workers exposed to formaldehyde an update

Occupational and Environmental Medicine

2004

61

193ndash200

39 Coggon D Harris EC Poole J

et al

Extended follow-up ofa cohort of British chemical workers exposed to formaldehyde

Journal of the National Cancer Institute

2003

21

1608ndash161440 Bertazzi PA Pesatori AC Radice L Zocchetti C Vai T

Exposure to formaldehyde and cancer mortality in a cohortof workers producing resins

Scandinavian Journal of WorkEnvironment and Health

1986

12

461ndash46841 Hauptmann M Lubin JH Stewart PA Hayes RB Blair A

Mortality from solid cancers among workers in formaldehydeindustries

American Journal of Epidemiology

2004

159

1117ndash1130

42 Blair A Stewart P OrsquoBerg M

et al

Mortality among indus-trial workers exposed to formaldehyde

Journal of theNational Cancer Institute

1986

76 1071ndash108443 Gardner MJ Pannett B Winter PD Cruddas AM A cohort

study of workers exposed to formaldehyde in the Britishchemical industry an update British Journal of IndustrialMedicine 1993 50 827ndash834

44 Hayes RB Blair A Stewart PA Herrick RF Mahar HMortality of US embalmers and funeral directors AmericanJournal of Industrial Medicine 1990 18 641ndash652

45 Collins JJ Esmen NA Hall TA A review and meta-analysisof formaldehyde exposure and pancreatic cancer AmericanJournal of Industrial Medicine 2001 39 336ndash345

46 Pashley EL Nelson R Pashley DH Systemic distribution of14C-formaldehyde with formocresol-treated pulpotomy sitesJournal of Dental Research 1980 59 603ndash608

47 Myers DR Shoaf HK Dirksen TR Distribution of 14C-formaldehyde after pulpotomy with formocresol Journal ofthe American Dental Association 1978 96 805ndash813

48 Zarzar PA Rosenblatt A Takahashi CS Takeuchi PL Costa

206 C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

LA Jr Formocresol mutagenicity following primary toothpulp therapy an in vivo study Journal of Dentistry 2003 31479ndash485

49 Messer LB Cline JT Korf NW Long-term effects of primarymolar pulpotomies on succedaneous bicuspids Journal ofDental Research 1980 29 116ndash123

50 Waterhouse PJ A comparison of the relative efficacy offormocresol versus calcium hydroxide as vital pulp therapyagents in primary molars PhD Thesis Newcastle upon TyneUniversity of Newcastle upon Tyne 2000

51 International Agency for Research on Cancer Press releaseno 153 15 June 2004 [WWW document] URL httpwwwiarcfrpagerootPRELEASESpr153ahtml

52 National Pathways Association NPA definition of a pathwayof care NPA Newsletter 1998 Spring 2

53 Currie L Harvey G The Origins and Uses of Care Pathwaysin the USA Australia and the United Kingdom Report No 15London RCN Institute Oxford Centre Royal College ofNursing 1997

54 Hale C Issues in the evaluation of multidisciplinary pathwaysof care In Wilson J (ed) Integrated Care Management The Pathto Success Oxford Butterworth-Heinemann 1987 281ndash296

55 de Luc K Care pathways an evaluation of their effectivenessJournal of Advanced Nursing 2000 32 485ndash496

56 Currie L Care pathways development and implementationNursing Standard 1998 12 35ndash38

57 Goel V Decision analysis applications and limitationsCanadian Medical Association Journal 1992 147 413ndash417

58 Richardson WS Detsky AS Usersrsquo guides to the medicalliterature VII How to use a clinical decision analysis Arethe results of the study valid Journal of the American MedicalAssociation 1995 273 1292ndash1295

59 Ibricevic H Al-Jame Q Ferric sulfate as pulpotomy agent inprimary teeth twenty month clinical follow-up PediatricDentistry 2000 24 269ndash272

60 Ibricevic H Al-Jame Q Ferric sulphate and formocresol inpulpotomy of primary molars long term follow-up studyEuropean Journal of Paediatric Dentistry 2003 4 28ndash32

61 Casas MJ Kenny DJ Johnston DH Judd PJ Long-term out-comes of primary molar ferric sulfate pulpotomy and rootcanal therapy Pediatric Dentistry 2004 26 44ndash48

62 Papagiannoulis L Clinical studies on ferric sulphate as apulpotomy medicament in primary teeth European Journalof Paediatric Dentistry 2002 3 126ndash132

63 Salako N Joseph B Ritwik P Salonen J John P Junaid TAComparison of bioactive glass mineral trioxide aggregateferric sulphate and formocresol as pulpotomy agents in ratmolar Dental Traumatology 2003 19 314ndash320

64 Casas MJ Kenny DJ Johnston DH Judd PL Layug MAOutcomes of vital primary incisor ferric sulphate pulpotomyand root canal therapy Journal of the Canadian Dental Asso-ciation 2004 70 34ndash38

65 Casas MJ Layug MA Kenny DJ Johnston DH Judd PLTwo-year outcomes of primary molar ferric sulphate pulpot-omy and root canal therapy Pediatric Dentistry 2003 25 97ndash102

66 Cleaton-Jones P Duggal M Parak M Williams S Setze SFerric sulphate and formocresol pulpotomies in baboonprimary molars histological responses European Journal ofPaediatric Dentistry 2002 3 121ndash125

67 Dominguez MS Witherspoon DE Gutmann JL OppermanLA Histological and scanning electron microscopy assess-ment of various vital pulp-therapy materials Journal of Endo-dontics 2003 29 324ndash333

68 Waterhouse PJ Whitworth JM Nunn JH Development of amethod to detect and quantify Prostaglandin E2 in pulpalblood from cariously exposed vital primary molar teethInternational Endodontic Journal 1999 32 381ndash387

69 Waterhouse PJ Nunn JH Whitworth JM Prostaglandin E2and treatment outcome in pulp therapy of primary molarswith carious exposures International Journal of PaediatricDentistry 2002 12 116ndash123

70 Tickle M Milsom K King D Kearney-Mitchell P BlinkhornA The fate of the carious primary teeth of children whoregularly attend the general dental service British DentalJournal 2002 192 219ndash223

71 Milsom K Tickle M King D Does the dental professionknow how to care for the primary dentition British DentalJournal 2003 195 301ndash303

72 Pendlebury ME Horner K Eaton KA (eds) Selection Criteriafor Dental Radiography 2nd edn London Faculty of GeneralDental Practitioners (UK) The Royal College of Surgeons ofEngland 2004

73 Fuks AB Bimstein E Kelin H Assessment of a 2 percentbuffered glutaraldehyde solution in pulpotomized primaryteeth of school children a preliminary report Journal ofPedodontics 1986 10 323ndash330

74 Mack RB Dean JA Electrosurgical pulpotomy a retrospec-tive human study Journal of Dentistry for Children 1993 60107ndash114

75 Agamy HA Bakry NS Mounir MMF Avery DR Comparisonof mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth PediatricDentistry 2004 26 302ndash309

76 Elliot RD Roberts MW Burkes J Phillips C Evaluation ofthe carbon dioxide laser on vital human primary pulp tissuePaediatric Dentistry 1999 21 327ndash331

77 Al-Zayer MA Straffon LH Feigal RJ Welch KB Indirectpulp treatment of primary posterior teeth a retrospectivestudy Pediatric Dentistry 2003 25 29ndash36

78 Hansen HP Ravn JJ Ulrich D Vital pulpotomy in primarymolars A clinical and histological investigation of the effectof zinc-oxide eugenol cement and Ledermix ScandinavialJournal of Dental Research 1971 79 13ndash23

Development of a pulp therapy protocol

203

copy 2006 BSPD and IAPD

Fig 1 Primary molar protocol (MH) medical history (LA) local anaesthesia (RA) relative analgesia (GA) general anaesthesia (ADJ) amelodentinaljunction (GIC) glass ionomer cement (ZnOE) zinc oxide eugenol cement (PFMC) preformed metal crown and (GDP) general dental practitioner

204

C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

monitoring may be appropriate but only for patientswho are unable to accept operative treatment andwhere the tooth is asymptomatic and clinically andradiographically free of pathology It is advisablethat this decision is made with the consent of a fullyinformed parent because of the potential risk ofdamage to the permanent successor Monitoring isnot an option for patients to whom infection posesa significant risk for example those with leukaemiaor congenital heart defects

Radiographic review

Regular radiographic monitoring of treated teethis advocated to assist in the assessment of primarymolar and permanent successor teeth A radiographtaken after treatment would enable detection ofrecurrent caries a failing coronal restoration peri-apical or furcal radiolucencies internal or externalroot resorption failure of eruption of the permanentsuccessor tooth along its expected path and patho-sis with or without concomitant clinical symptomswhich may damage or deflect the permanent toothgerm [50]

Although the literature relating to the frequencyof radiographing pulpotomised teeth is scant theFaculty of General Dental Practitioners [72] clearlyoutlines selection criteria for radiographic screeningaccording to caries risk status These guidelines sug-gest that bitewing radiographs should be taken on a6-monthly basis for children identified as high cariesrisk and on an annual basis for those classified asmoderate risk The authors would suggest that a

vertical bitewing radiograph could be taken as part ofthis radiographic review because this would enablea review after pulp therapy without an increase inradiation dose

Conclusion

Following a review of the current literature a workingclinical protocol for pulp therapy techniques in theextensively carious primary molar has been developedThis protocol has been implemented at the under-graduate and postgraduate levels and has helped toidentify areas where further staff training is requiredIt is expected that the clinical protocol will evolve asfurther evidence comes to light

Acknowledgements

The authors would like to thank the following fortheir significant contributions to the developmentof the protocol Dr Andrew Shaw Dr Ben ColeDr Anne Maguire Dr Loraine Lowry Mrs VirginiaHind and Mrs Solape Adeboye

References

1 Buckley JP The chemistry of pulp decomposition with arational treatment for this condition and its sequelae

AmericanDental Journal

1904

3

764ndash7712 Sweet CA Jr Procedure for treatment of exposed and pulpless

deciduous teeth

Journal of the American Dental Association

1930

17

1150ndash11533 Roslashlling I Thylstrup A A 3-year clinical follow-up study of

pulpotomised primary molars treated with the formocresoltechnique

Scandinavian Journal of Dental Research

1975

83

47ndash534 Magnusson BO Therapeutic pulpotomies in primary molars

with the formocresol technique A clinical and histologicalfollow-up

Acta Odontologica Scandinavica

1978

36

157ndash165

5 Mejagravere I Pulpotomy of primary molars with coronal or totalpulpitis using formocresol technique

Scandinavian Journalof Dental Research

1979

87

208ndash2166 Magnusson BO Pulpotomy in primary molars long term

clinical and histological evaluation

International EndodonticJournal

1980

13

143ndash1557 Verco PJW Allen KR Formocresol pulpotomies in primary

teeth

Journal of the International Association of Dentistryfor Children

1984

15

51ndash558 Hicks MJ Barr ES Flaitz CM Formocresol pulpotomies in

primary molars a radiographic study in a paediatric dentistrypractice

Journal of Pedodontics

1986

10

331ndash3399 Morawa AP Straffon LH Han SS Copron RE Clinical

evaluation of pulpotomies using dilute formocresol

ASDCJournal of Dentistry for Children

1975

42

360ndash36310 Fuks AB Bimstein E Clinical evaluation of diluted formocresol

What this paper adds

bull This paper highlights the stages in the development ofa local clinical protocol

bull The protocol consisted of a flow chart to assist cliniciansin their treatment planning combined with a key pointsdocument to offer further information and to standardisedata for future research and audit

Why this paper is important for paediatric dentists

bull Prior to the use of any clinical intervention the evidencebase behind it requires consideration

bull In order to justify its use within any clinical setting (beit primary dental care or an NHS teaching hospital)a medicament or technique must be effective from aclinical and economical perspective

bull Ferric sulphate was chosen within our protocol as thetreatment of choice for vital pulpotomies as it appearsto be as effective as fromocresol in vital pulpotomies todate and there is no evidence to suggest any adverseeffects from this medicament

Development of a pulp therapy protocol

205

copy 2006 BSPD and IAPD

pulpotomies in primary teeth of schoolchildren

PediatricDentistry

1981

3

321ndash32411 Garcia-Godoy F Direct pulp capping and partial pulpotomy

with diluted formocresol in primary molars

Acta de OdontologicaPediatrica

1984

5

57ndash6112 Prakash C Chandra S Jaiswal JN Formocresol and glutaralde-

hyde pulpotomies in primary teeth

Journal of Pedodontics

1989

13

314ndash32213 Formaldehyde Panel

Report of the Federal Panel on Formaldehyde

Research Triangle Park NC National Toxicology Program 1980

14 Lewis BB Chestner SB Formaldehyde in dentistry a reviewof mutagenic and carcinogenic potential

Journal of the AmericanDental Association

1981

103

429ndash43415 Block RM Lewis RD Hirsch J Coffey J Langeland K Systemic

distribution of

14

C-labeled paraformaldehyde incorporatedwithin formocresol following pulpotomies in dogs

Journal ofEndodontics

1983

9

176ndash18916 Waterhouse PJ Formocresol and alternative primary molar

pulpotomy medicaments a review

Endodontics and DentalTraumatology

1995

11

157ndash16217 Judd PL Kenny DJ Formocresol concerns a review

Journalof the Canadian Dental Association

1987

5

401ndash40418 Wilkins RJ McLeod HD Formaldehyde induced DNA-protein

cross-links in

Escherichia coli

Mutation Research

1976

36

11ndash16

19 Takahashi K Morita T Kawazoe Y Mutagenic characteristicsof formaldehyde on bacterial systems

Mutation Research

1985

156

153ndash16120 Kaplan WD Formaldehyde as a mutagen in Drosophila

Science

1948

108

4321 Soffritti M Belpoggi F Lambertin L Lauriola M Padovani M

Maltoni C Results of long-term experimental studies on thecarcinogenicity of formaldehyde and acetaldehyde in rats

Annals of the New York Academy of Sciences

2002

982

87ndash105

22 Swenberg JA Kerns WD Mitchell RI Gralla EJ Pavkov KLInduction of squamous cell carcinomas of the rat nasalcavity by inhalation exposure to formaldehyde vapour

CancerResearch

1980

40

3398ndash340223 Mueller R Raabe G Schumann D Leukoplakia induced by

repeated deposition of formalin in rabbit oral mucosa longterm experiments in a new lsquooral tankrsquo

Experimental Pathology

1978

16

36ndash4224 Bolt HM Experimental toxicology of formaldehyde

Journalof Cancer Research and Clinical Oncology

1987

113

305ndash30925 Bernstein RS Stayner LT Elliot LI Kimbrough RK Inhala-

tion exposure to formaldehyde an overview of its toxicologyepidemiology monitoring and control

American IndustrialHygiene Association Journal

1984

45

778ndash78526 Goldmacher VS Thilly WD Formaldehyde is mutagenic for

cultured human cells

Mutation Research

1983

116

417ndash422

27 He JL Jin LF Jin HY Detection of cytogenic effects inperipheral lymphocytes of students exposed to formaldehydewith cytokinesis-blocked micronucleus assay

Biomedical andEnvironmental Sciences

1998

11

87ndash9228 Bauchinger M Schmid E Cytogenic effects in lymphocytes

of formaldehyde workers of a paper factory

MutationResearch

1985

158

195ndash19929 Kitaeva LV Mikheeva EA Shelomova LF Shvartsman PI

Genotoxic effect of formaldehyde in somatic human cells

invivo

[in Russian]

Genetika

1996

32

1287ndash129030 Suruda A Schulte P Boeniger M

et al

Cytogenetic effectsof formaldehyde exposure in students of mortuary science

Cancer Epidemiology Biomarkers and Prevention

1993

2

453ndash460

31 Shaham J Bomstein Y Meltzer A Ribak J DNA-proteincrosslinks a biomarker of exposure to formaldehyde ndash

invitro

and

in vivo

studies

Carcinogenesis

1996

17

121ndash12532 Shaham J Bomstein Y Meltzer A Kaufman Z Palma E

Ribak J DNA-protein crosslinks and sister chromatidexchanges as biomarkers of exposure to formaldehyde

Inter-national Journal of Occupational Medicine and EnvironmentalHealth

1997

3

95ndash10433 Yager JW Cohn KL Spear RC Fisher JM Morse L Sister-

chromatid exchanges in lymphocytes of anatomy studentsexposed to formaldehyde embalming solution

MutationResearch

1986

174

135ndash13934 Shaham J Gurvich R Kaufman Z Sister chromatid exchange

in pathology staff occupationally exposed to formaldehyde

Mutation Research

2002

15

115ndash12335 Bonassi S Hagmar L Stromberg U

et al

Chromosomal aber-rations in lymphocytes predict human cancer independentlyof exposure to carcinogens European Study Group onCytogenetic Biomarkers and Health

Cancer Research

2000

60

1619ndash162536 Tucker JD Preston RJ Chromosome aberrations micronuclei

aneuploidy sister chromatid exchanges and cancer riskassessment

Mutation Research

1996

365

147ndash15937 Hauptmann M Lubin JH Stewart PA Hayes RB Blair A

Mortality from lymphohematopoietic malignancies amongworkers in formaldehyde industries

Journal of the NationalCancer Institute

2003

95

1615ndash162338 Pinkerton L Hein M Stayner L Mortality among a cohort

of garment workers exposed to formaldehyde an update

Occupational and Environmental Medicine

2004

61

193ndash200

39 Coggon D Harris EC Poole J

et al

Extended follow-up ofa cohort of British chemical workers exposed to formaldehyde

Journal of the National Cancer Institute

2003

21

1608ndash161440 Bertazzi PA Pesatori AC Radice L Zocchetti C Vai T

Exposure to formaldehyde and cancer mortality in a cohortof workers producing resins

Scandinavian Journal of WorkEnvironment and Health

1986

12

461ndash46841 Hauptmann M Lubin JH Stewart PA Hayes RB Blair A

Mortality from solid cancers among workers in formaldehydeindustries

American Journal of Epidemiology

2004

159

1117ndash1130

42 Blair A Stewart P OrsquoBerg M

et al

Mortality among indus-trial workers exposed to formaldehyde

Journal of theNational Cancer Institute

1986

76 1071ndash108443 Gardner MJ Pannett B Winter PD Cruddas AM A cohort

study of workers exposed to formaldehyde in the Britishchemical industry an update British Journal of IndustrialMedicine 1993 50 827ndash834

44 Hayes RB Blair A Stewart PA Herrick RF Mahar HMortality of US embalmers and funeral directors AmericanJournal of Industrial Medicine 1990 18 641ndash652

45 Collins JJ Esmen NA Hall TA A review and meta-analysisof formaldehyde exposure and pancreatic cancer AmericanJournal of Industrial Medicine 2001 39 336ndash345

46 Pashley EL Nelson R Pashley DH Systemic distribution of14C-formaldehyde with formocresol-treated pulpotomy sitesJournal of Dental Research 1980 59 603ndash608

47 Myers DR Shoaf HK Dirksen TR Distribution of 14C-formaldehyde after pulpotomy with formocresol Journal ofthe American Dental Association 1978 96 805ndash813

48 Zarzar PA Rosenblatt A Takahashi CS Takeuchi PL Costa

206 C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

LA Jr Formocresol mutagenicity following primary toothpulp therapy an in vivo study Journal of Dentistry 2003 31479ndash485

49 Messer LB Cline JT Korf NW Long-term effects of primarymolar pulpotomies on succedaneous bicuspids Journal ofDental Research 1980 29 116ndash123

50 Waterhouse PJ A comparison of the relative efficacy offormocresol versus calcium hydroxide as vital pulp therapyagents in primary molars PhD Thesis Newcastle upon TyneUniversity of Newcastle upon Tyne 2000

51 International Agency for Research on Cancer Press releaseno 153 15 June 2004 [WWW document] URL httpwwwiarcfrpagerootPRELEASESpr153ahtml

52 National Pathways Association NPA definition of a pathwayof care NPA Newsletter 1998 Spring 2

53 Currie L Harvey G The Origins and Uses of Care Pathwaysin the USA Australia and the United Kingdom Report No 15London RCN Institute Oxford Centre Royal College ofNursing 1997

54 Hale C Issues in the evaluation of multidisciplinary pathwaysof care In Wilson J (ed) Integrated Care Management The Pathto Success Oxford Butterworth-Heinemann 1987 281ndash296

55 de Luc K Care pathways an evaluation of their effectivenessJournal of Advanced Nursing 2000 32 485ndash496

56 Currie L Care pathways development and implementationNursing Standard 1998 12 35ndash38

57 Goel V Decision analysis applications and limitationsCanadian Medical Association Journal 1992 147 413ndash417

58 Richardson WS Detsky AS Usersrsquo guides to the medicalliterature VII How to use a clinical decision analysis Arethe results of the study valid Journal of the American MedicalAssociation 1995 273 1292ndash1295

59 Ibricevic H Al-Jame Q Ferric sulfate as pulpotomy agent inprimary teeth twenty month clinical follow-up PediatricDentistry 2000 24 269ndash272

60 Ibricevic H Al-Jame Q Ferric sulphate and formocresol inpulpotomy of primary molars long term follow-up studyEuropean Journal of Paediatric Dentistry 2003 4 28ndash32

61 Casas MJ Kenny DJ Johnston DH Judd PJ Long-term out-comes of primary molar ferric sulfate pulpotomy and rootcanal therapy Pediatric Dentistry 2004 26 44ndash48

62 Papagiannoulis L Clinical studies on ferric sulphate as apulpotomy medicament in primary teeth European Journalof Paediatric Dentistry 2002 3 126ndash132

63 Salako N Joseph B Ritwik P Salonen J John P Junaid TAComparison of bioactive glass mineral trioxide aggregateferric sulphate and formocresol as pulpotomy agents in ratmolar Dental Traumatology 2003 19 314ndash320

64 Casas MJ Kenny DJ Johnston DH Judd PL Layug MAOutcomes of vital primary incisor ferric sulphate pulpotomyand root canal therapy Journal of the Canadian Dental Asso-ciation 2004 70 34ndash38

65 Casas MJ Layug MA Kenny DJ Johnston DH Judd PLTwo-year outcomes of primary molar ferric sulphate pulpot-omy and root canal therapy Pediatric Dentistry 2003 25 97ndash102

66 Cleaton-Jones P Duggal M Parak M Williams S Setze SFerric sulphate and formocresol pulpotomies in baboonprimary molars histological responses European Journal ofPaediatric Dentistry 2002 3 121ndash125

67 Dominguez MS Witherspoon DE Gutmann JL OppermanLA Histological and scanning electron microscopy assess-ment of various vital pulp-therapy materials Journal of Endo-dontics 2003 29 324ndash333

68 Waterhouse PJ Whitworth JM Nunn JH Development of amethod to detect and quantify Prostaglandin E2 in pulpalblood from cariously exposed vital primary molar teethInternational Endodontic Journal 1999 32 381ndash387

69 Waterhouse PJ Nunn JH Whitworth JM Prostaglandin E2and treatment outcome in pulp therapy of primary molarswith carious exposures International Journal of PaediatricDentistry 2002 12 116ndash123

70 Tickle M Milsom K King D Kearney-Mitchell P BlinkhornA The fate of the carious primary teeth of children whoregularly attend the general dental service British DentalJournal 2002 192 219ndash223

71 Milsom K Tickle M King D Does the dental professionknow how to care for the primary dentition British DentalJournal 2003 195 301ndash303

72 Pendlebury ME Horner K Eaton KA (eds) Selection Criteriafor Dental Radiography 2nd edn London Faculty of GeneralDental Practitioners (UK) The Royal College of Surgeons ofEngland 2004

73 Fuks AB Bimstein E Kelin H Assessment of a 2 percentbuffered glutaraldehyde solution in pulpotomized primaryteeth of school children a preliminary report Journal ofPedodontics 1986 10 323ndash330

74 Mack RB Dean JA Electrosurgical pulpotomy a retrospec-tive human study Journal of Dentistry for Children 1993 60107ndash114

75 Agamy HA Bakry NS Mounir MMF Avery DR Comparisonof mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth PediatricDentistry 2004 26 302ndash309

76 Elliot RD Roberts MW Burkes J Phillips C Evaluation ofthe carbon dioxide laser on vital human primary pulp tissuePaediatric Dentistry 1999 21 327ndash331

77 Al-Zayer MA Straffon LH Feigal RJ Welch KB Indirectpulp treatment of primary posterior teeth a retrospectivestudy Pediatric Dentistry 2003 25 29ndash36

78 Hansen HP Ravn JJ Ulrich D Vital pulpotomy in primarymolars A clinical and histological investigation of the effectof zinc-oxide eugenol cement and Ledermix ScandinavialJournal of Dental Research 1971 79 13ndash23

204

C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

monitoring may be appropriate but only for patientswho are unable to accept operative treatment andwhere the tooth is asymptomatic and clinically andradiographically free of pathology It is advisablethat this decision is made with the consent of a fullyinformed parent because of the potential risk ofdamage to the permanent successor Monitoring isnot an option for patients to whom infection posesa significant risk for example those with leukaemiaor congenital heart defects

Radiographic review

Regular radiographic monitoring of treated teethis advocated to assist in the assessment of primarymolar and permanent successor teeth A radiographtaken after treatment would enable detection ofrecurrent caries a failing coronal restoration peri-apical or furcal radiolucencies internal or externalroot resorption failure of eruption of the permanentsuccessor tooth along its expected path and patho-sis with or without concomitant clinical symptomswhich may damage or deflect the permanent toothgerm [50]

Although the literature relating to the frequencyof radiographing pulpotomised teeth is scant theFaculty of General Dental Practitioners [72] clearlyoutlines selection criteria for radiographic screeningaccording to caries risk status These guidelines sug-gest that bitewing radiographs should be taken on a6-monthly basis for children identified as high cariesrisk and on an annual basis for those classified asmoderate risk The authors would suggest that a

vertical bitewing radiograph could be taken as part ofthis radiographic review because this would enablea review after pulp therapy without an increase inradiation dose

Conclusion

Following a review of the current literature a workingclinical protocol for pulp therapy techniques in theextensively carious primary molar has been developedThis protocol has been implemented at the under-graduate and postgraduate levels and has helped toidentify areas where further staff training is requiredIt is expected that the clinical protocol will evolve asfurther evidence comes to light

Acknowledgements

The authors would like to thank the following fortheir significant contributions to the developmentof the protocol Dr Andrew Shaw Dr Ben ColeDr Anne Maguire Dr Loraine Lowry Mrs VirginiaHind and Mrs Solape Adeboye

References

1 Buckley JP The chemistry of pulp decomposition with arational treatment for this condition and its sequelae

AmericanDental Journal

1904

3

764ndash7712 Sweet CA Jr Procedure for treatment of exposed and pulpless

deciduous teeth

Journal of the American Dental Association

1930

17

1150ndash11533 Roslashlling I Thylstrup A A 3-year clinical follow-up study of

pulpotomised primary molars treated with the formocresoltechnique

Scandinavian Journal of Dental Research

1975

83

47ndash534 Magnusson BO Therapeutic pulpotomies in primary molars

with the formocresol technique A clinical and histologicalfollow-up

Acta Odontologica Scandinavica

1978

36

157ndash165

5 Mejagravere I Pulpotomy of primary molars with coronal or totalpulpitis using formocresol technique

Scandinavian Journalof Dental Research

1979

87

208ndash2166 Magnusson BO Pulpotomy in primary molars long term

clinical and histological evaluation

International EndodonticJournal

1980

13

143ndash1557 Verco PJW Allen KR Formocresol pulpotomies in primary

teeth

Journal of the International Association of Dentistryfor Children

1984

15

51ndash558 Hicks MJ Barr ES Flaitz CM Formocresol pulpotomies in

primary molars a radiographic study in a paediatric dentistrypractice

Journal of Pedodontics

1986

10

331ndash3399 Morawa AP Straffon LH Han SS Copron RE Clinical

evaluation of pulpotomies using dilute formocresol

ASDCJournal of Dentistry for Children

1975

42

360ndash36310 Fuks AB Bimstein E Clinical evaluation of diluted formocresol

What this paper adds

bull This paper highlights the stages in the development ofa local clinical protocol

bull The protocol consisted of a flow chart to assist cliniciansin their treatment planning combined with a key pointsdocument to offer further information and to standardisedata for future research and audit

Why this paper is important for paediatric dentists

bull Prior to the use of any clinical intervention the evidencebase behind it requires consideration

bull In order to justify its use within any clinical setting (beit primary dental care or an NHS teaching hospital)a medicament or technique must be effective from aclinical and economical perspective

bull Ferric sulphate was chosen within our protocol as thetreatment of choice for vital pulpotomies as it appearsto be as effective as fromocresol in vital pulpotomies todate and there is no evidence to suggest any adverseeffects from this medicament

Development of a pulp therapy protocol

205

copy 2006 BSPD and IAPD

pulpotomies in primary teeth of schoolchildren

PediatricDentistry

1981

3

321ndash32411 Garcia-Godoy F Direct pulp capping and partial pulpotomy

with diluted formocresol in primary molars

Acta de OdontologicaPediatrica

1984

5

57ndash6112 Prakash C Chandra S Jaiswal JN Formocresol and glutaralde-

hyde pulpotomies in primary teeth

Journal of Pedodontics

1989

13

314ndash32213 Formaldehyde Panel

Report of the Federal Panel on Formaldehyde

Research Triangle Park NC National Toxicology Program 1980

14 Lewis BB Chestner SB Formaldehyde in dentistry a reviewof mutagenic and carcinogenic potential

Journal of the AmericanDental Association

1981

103

429ndash43415 Block RM Lewis RD Hirsch J Coffey J Langeland K Systemic

distribution of

14

C-labeled paraformaldehyde incorporatedwithin formocresol following pulpotomies in dogs

Journal ofEndodontics

1983

9

176ndash18916 Waterhouse PJ Formocresol and alternative primary molar

pulpotomy medicaments a review

Endodontics and DentalTraumatology

1995

11

157ndash16217 Judd PL Kenny DJ Formocresol concerns a review

Journalof the Canadian Dental Association

1987

5

401ndash40418 Wilkins RJ McLeod HD Formaldehyde induced DNA-protein

cross-links in

Escherichia coli

Mutation Research

1976

36

11ndash16

19 Takahashi K Morita T Kawazoe Y Mutagenic characteristicsof formaldehyde on bacterial systems

Mutation Research

1985

156

153ndash16120 Kaplan WD Formaldehyde as a mutagen in Drosophila

Science

1948

108

4321 Soffritti M Belpoggi F Lambertin L Lauriola M Padovani M

Maltoni C Results of long-term experimental studies on thecarcinogenicity of formaldehyde and acetaldehyde in rats

Annals of the New York Academy of Sciences

2002

982

87ndash105

22 Swenberg JA Kerns WD Mitchell RI Gralla EJ Pavkov KLInduction of squamous cell carcinomas of the rat nasalcavity by inhalation exposure to formaldehyde vapour

CancerResearch

1980

40

3398ndash340223 Mueller R Raabe G Schumann D Leukoplakia induced by

repeated deposition of formalin in rabbit oral mucosa longterm experiments in a new lsquooral tankrsquo

Experimental Pathology

1978

16

36ndash4224 Bolt HM Experimental toxicology of formaldehyde

Journalof Cancer Research and Clinical Oncology

1987

113

305ndash30925 Bernstein RS Stayner LT Elliot LI Kimbrough RK Inhala-

tion exposure to formaldehyde an overview of its toxicologyepidemiology monitoring and control

American IndustrialHygiene Association Journal

1984

45

778ndash78526 Goldmacher VS Thilly WD Formaldehyde is mutagenic for

cultured human cells

Mutation Research

1983

116

417ndash422

27 He JL Jin LF Jin HY Detection of cytogenic effects inperipheral lymphocytes of students exposed to formaldehydewith cytokinesis-blocked micronucleus assay

Biomedical andEnvironmental Sciences

1998

11

87ndash9228 Bauchinger M Schmid E Cytogenic effects in lymphocytes

of formaldehyde workers of a paper factory

MutationResearch

1985

158

195ndash19929 Kitaeva LV Mikheeva EA Shelomova LF Shvartsman PI

Genotoxic effect of formaldehyde in somatic human cells

invivo

[in Russian]

Genetika

1996

32

1287ndash129030 Suruda A Schulte P Boeniger M

et al

Cytogenetic effectsof formaldehyde exposure in students of mortuary science

Cancer Epidemiology Biomarkers and Prevention

1993

2

453ndash460

31 Shaham J Bomstein Y Meltzer A Ribak J DNA-proteincrosslinks a biomarker of exposure to formaldehyde ndash

invitro

and

in vivo

studies

Carcinogenesis

1996

17

121ndash12532 Shaham J Bomstein Y Meltzer A Kaufman Z Palma E

Ribak J DNA-protein crosslinks and sister chromatidexchanges as biomarkers of exposure to formaldehyde

Inter-national Journal of Occupational Medicine and EnvironmentalHealth

1997

3

95ndash10433 Yager JW Cohn KL Spear RC Fisher JM Morse L Sister-

chromatid exchanges in lymphocytes of anatomy studentsexposed to formaldehyde embalming solution

MutationResearch

1986

174

135ndash13934 Shaham J Gurvich R Kaufman Z Sister chromatid exchange

in pathology staff occupationally exposed to formaldehyde

Mutation Research

2002

15

115ndash12335 Bonassi S Hagmar L Stromberg U

et al

Chromosomal aber-rations in lymphocytes predict human cancer independentlyof exposure to carcinogens European Study Group onCytogenetic Biomarkers and Health

Cancer Research

2000

60

1619ndash162536 Tucker JD Preston RJ Chromosome aberrations micronuclei

aneuploidy sister chromatid exchanges and cancer riskassessment

Mutation Research

1996

365

147ndash15937 Hauptmann M Lubin JH Stewart PA Hayes RB Blair A

Mortality from lymphohematopoietic malignancies amongworkers in formaldehyde industries

Journal of the NationalCancer Institute

2003

95

1615ndash162338 Pinkerton L Hein M Stayner L Mortality among a cohort

of garment workers exposed to formaldehyde an update

Occupational and Environmental Medicine

2004

61

193ndash200

39 Coggon D Harris EC Poole J

et al

Extended follow-up ofa cohort of British chemical workers exposed to formaldehyde

Journal of the National Cancer Institute

2003

21

1608ndash161440 Bertazzi PA Pesatori AC Radice L Zocchetti C Vai T

Exposure to formaldehyde and cancer mortality in a cohortof workers producing resins

Scandinavian Journal of WorkEnvironment and Health

1986

12

461ndash46841 Hauptmann M Lubin JH Stewart PA Hayes RB Blair A

Mortality from solid cancers among workers in formaldehydeindustries

American Journal of Epidemiology

2004

159

1117ndash1130

42 Blair A Stewart P OrsquoBerg M

et al

Mortality among indus-trial workers exposed to formaldehyde

Journal of theNational Cancer Institute

1986

76 1071ndash108443 Gardner MJ Pannett B Winter PD Cruddas AM A cohort

study of workers exposed to formaldehyde in the Britishchemical industry an update British Journal of IndustrialMedicine 1993 50 827ndash834

44 Hayes RB Blair A Stewart PA Herrick RF Mahar HMortality of US embalmers and funeral directors AmericanJournal of Industrial Medicine 1990 18 641ndash652

45 Collins JJ Esmen NA Hall TA A review and meta-analysisof formaldehyde exposure and pancreatic cancer AmericanJournal of Industrial Medicine 2001 39 336ndash345

46 Pashley EL Nelson R Pashley DH Systemic distribution of14C-formaldehyde with formocresol-treated pulpotomy sitesJournal of Dental Research 1980 59 603ndash608

47 Myers DR Shoaf HK Dirksen TR Distribution of 14C-formaldehyde after pulpotomy with formocresol Journal ofthe American Dental Association 1978 96 805ndash813

48 Zarzar PA Rosenblatt A Takahashi CS Takeuchi PL Costa

206 C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

LA Jr Formocresol mutagenicity following primary toothpulp therapy an in vivo study Journal of Dentistry 2003 31479ndash485

49 Messer LB Cline JT Korf NW Long-term effects of primarymolar pulpotomies on succedaneous bicuspids Journal ofDental Research 1980 29 116ndash123

50 Waterhouse PJ A comparison of the relative efficacy offormocresol versus calcium hydroxide as vital pulp therapyagents in primary molars PhD Thesis Newcastle upon TyneUniversity of Newcastle upon Tyne 2000

51 International Agency for Research on Cancer Press releaseno 153 15 June 2004 [WWW document] URL httpwwwiarcfrpagerootPRELEASESpr153ahtml

52 National Pathways Association NPA definition of a pathwayof care NPA Newsletter 1998 Spring 2

53 Currie L Harvey G The Origins and Uses of Care Pathwaysin the USA Australia and the United Kingdom Report No 15London RCN Institute Oxford Centre Royal College ofNursing 1997

54 Hale C Issues in the evaluation of multidisciplinary pathwaysof care In Wilson J (ed) Integrated Care Management The Pathto Success Oxford Butterworth-Heinemann 1987 281ndash296

55 de Luc K Care pathways an evaluation of their effectivenessJournal of Advanced Nursing 2000 32 485ndash496

56 Currie L Care pathways development and implementationNursing Standard 1998 12 35ndash38

57 Goel V Decision analysis applications and limitationsCanadian Medical Association Journal 1992 147 413ndash417

58 Richardson WS Detsky AS Usersrsquo guides to the medicalliterature VII How to use a clinical decision analysis Arethe results of the study valid Journal of the American MedicalAssociation 1995 273 1292ndash1295

59 Ibricevic H Al-Jame Q Ferric sulfate as pulpotomy agent inprimary teeth twenty month clinical follow-up PediatricDentistry 2000 24 269ndash272

60 Ibricevic H Al-Jame Q Ferric sulphate and formocresol inpulpotomy of primary molars long term follow-up studyEuropean Journal of Paediatric Dentistry 2003 4 28ndash32

61 Casas MJ Kenny DJ Johnston DH Judd PJ Long-term out-comes of primary molar ferric sulfate pulpotomy and rootcanal therapy Pediatric Dentistry 2004 26 44ndash48

62 Papagiannoulis L Clinical studies on ferric sulphate as apulpotomy medicament in primary teeth European Journalof Paediatric Dentistry 2002 3 126ndash132

63 Salako N Joseph B Ritwik P Salonen J John P Junaid TAComparison of bioactive glass mineral trioxide aggregateferric sulphate and formocresol as pulpotomy agents in ratmolar Dental Traumatology 2003 19 314ndash320

64 Casas MJ Kenny DJ Johnston DH Judd PL Layug MAOutcomes of vital primary incisor ferric sulphate pulpotomyand root canal therapy Journal of the Canadian Dental Asso-ciation 2004 70 34ndash38

65 Casas MJ Layug MA Kenny DJ Johnston DH Judd PLTwo-year outcomes of primary molar ferric sulphate pulpot-omy and root canal therapy Pediatric Dentistry 2003 25 97ndash102

66 Cleaton-Jones P Duggal M Parak M Williams S Setze SFerric sulphate and formocresol pulpotomies in baboonprimary molars histological responses European Journal ofPaediatric Dentistry 2002 3 121ndash125

67 Dominguez MS Witherspoon DE Gutmann JL OppermanLA Histological and scanning electron microscopy assess-ment of various vital pulp-therapy materials Journal of Endo-dontics 2003 29 324ndash333

68 Waterhouse PJ Whitworth JM Nunn JH Development of amethod to detect and quantify Prostaglandin E2 in pulpalblood from cariously exposed vital primary molar teethInternational Endodontic Journal 1999 32 381ndash387

69 Waterhouse PJ Nunn JH Whitworth JM Prostaglandin E2and treatment outcome in pulp therapy of primary molarswith carious exposures International Journal of PaediatricDentistry 2002 12 116ndash123

70 Tickle M Milsom K King D Kearney-Mitchell P BlinkhornA The fate of the carious primary teeth of children whoregularly attend the general dental service British DentalJournal 2002 192 219ndash223

71 Milsom K Tickle M King D Does the dental professionknow how to care for the primary dentition British DentalJournal 2003 195 301ndash303

72 Pendlebury ME Horner K Eaton KA (eds) Selection Criteriafor Dental Radiography 2nd edn London Faculty of GeneralDental Practitioners (UK) The Royal College of Surgeons ofEngland 2004

73 Fuks AB Bimstein E Kelin H Assessment of a 2 percentbuffered glutaraldehyde solution in pulpotomized primaryteeth of school children a preliminary report Journal ofPedodontics 1986 10 323ndash330

74 Mack RB Dean JA Electrosurgical pulpotomy a retrospec-tive human study Journal of Dentistry for Children 1993 60107ndash114

75 Agamy HA Bakry NS Mounir MMF Avery DR Comparisonof mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth PediatricDentistry 2004 26 302ndash309

76 Elliot RD Roberts MW Burkes J Phillips C Evaluation ofthe carbon dioxide laser on vital human primary pulp tissuePaediatric Dentistry 1999 21 327ndash331

77 Al-Zayer MA Straffon LH Feigal RJ Welch KB Indirectpulp treatment of primary posterior teeth a retrospectivestudy Pediatric Dentistry 2003 25 29ndash36

78 Hansen HP Ravn JJ Ulrich D Vital pulpotomy in primarymolars A clinical and histological investigation of the effectof zinc-oxide eugenol cement and Ledermix ScandinavialJournal of Dental Research 1971 79 13ndash23

Development of a pulp therapy protocol

205

copy 2006 BSPD and IAPD

pulpotomies in primary teeth of schoolchildren

PediatricDentistry

1981

3

321ndash32411 Garcia-Godoy F Direct pulp capping and partial pulpotomy

with diluted formocresol in primary molars

Acta de OdontologicaPediatrica

1984

5

57ndash6112 Prakash C Chandra S Jaiswal JN Formocresol and glutaralde-

hyde pulpotomies in primary teeth

Journal of Pedodontics

1989

13

314ndash32213 Formaldehyde Panel

Report of the Federal Panel on Formaldehyde

Research Triangle Park NC National Toxicology Program 1980

14 Lewis BB Chestner SB Formaldehyde in dentistry a reviewof mutagenic and carcinogenic potential

Journal of the AmericanDental Association

1981

103

429ndash43415 Block RM Lewis RD Hirsch J Coffey J Langeland K Systemic

distribution of

14

C-labeled paraformaldehyde incorporatedwithin formocresol following pulpotomies in dogs

Journal ofEndodontics

1983

9

176ndash18916 Waterhouse PJ Formocresol and alternative primary molar

pulpotomy medicaments a review

Endodontics and DentalTraumatology

1995

11

157ndash16217 Judd PL Kenny DJ Formocresol concerns a review

Journalof the Canadian Dental Association

1987

5

401ndash40418 Wilkins RJ McLeod HD Formaldehyde induced DNA-protein

cross-links in

Escherichia coli

Mutation Research

1976

36

11ndash16

19 Takahashi K Morita T Kawazoe Y Mutagenic characteristicsof formaldehyde on bacterial systems

Mutation Research

1985

156

153ndash16120 Kaplan WD Formaldehyde as a mutagen in Drosophila

Science

1948

108

4321 Soffritti M Belpoggi F Lambertin L Lauriola M Padovani M

Maltoni C Results of long-term experimental studies on thecarcinogenicity of formaldehyde and acetaldehyde in rats

Annals of the New York Academy of Sciences

2002

982

87ndash105

22 Swenberg JA Kerns WD Mitchell RI Gralla EJ Pavkov KLInduction of squamous cell carcinomas of the rat nasalcavity by inhalation exposure to formaldehyde vapour

CancerResearch

1980

40

3398ndash340223 Mueller R Raabe G Schumann D Leukoplakia induced by

repeated deposition of formalin in rabbit oral mucosa longterm experiments in a new lsquooral tankrsquo

Experimental Pathology

1978

16

36ndash4224 Bolt HM Experimental toxicology of formaldehyde

Journalof Cancer Research and Clinical Oncology

1987

113

305ndash30925 Bernstein RS Stayner LT Elliot LI Kimbrough RK Inhala-

tion exposure to formaldehyde an overview of its toxicologyepidemiology monitoring and control

American IndustrialHygiene Association Journal

1984

45

778ndash78526 Goldmacher VS Thilly WD Formaldehyde is mutagenic for

cultured human cells

Mutation Research

1983

116

417ndash422

27 He JL Jin LF Jin HY Detection of cytogenic effects inperipheral lymphocytes of students exposed to formaldehydewith cytokinesis-blocked micronucleus assay

Biomedical andEnvironmental Sciences

1998

11

87ndash9228 Bauchinger M Schmid E Cytogenic effects in lymphocytes

of formaldehyde workers of a paper factory

MutationResearch

1985

158

195ndash19929 Kitaeva LV Mikheeva EA Shelomova LF Shvartsman PI

Genotoxic effect of formaldehyde in somatic human cells

invivo

[in Russian]

Genetika

1996

32

1287ndash129030 Suruda A Schulte P Boeniger M

et al

Cytogenetic effectsof formaldehyde exposure in students of mortuary science

Cancer Epidemiology Biomarkers and Prevention

1993

2

453ndash460

31 Shaham J Bomstein Y Meltzer A Ribak J DNA-proteincrosslinks a biomarker of exposure to formaldehyde ndash

invitro

and

in vivo

studies

Carcinogenesis

1996

17

121ndash12532 Shaham J Bomstein Y Meltzer A Kaufman Z Palma E

Ribak J DNA-protein crosslinks and sister chromatidexchanges as biomarkers of exposure to formaldehyde

Inter-national Journal of Occupational Medicine and EnvironmentalHealth

1997

3

95ndash10433 Yager JW Cohn KL Spear RC Fisher JM Morse L Sister-

chromatid exchanges in lymphocytes of anatomy studentsexposed to formaldehyde embalming solution

MutationResearch

1986

174

135ndash13934 Shaham J Gurvich R Kaufman Z Sister chromatid exchange

in pathology staff occupationally exposed to formaldehyde

Mutation Research

2002

15

115ndash12335 Bonassi S Hagmar L Stromberg U

et al

Chromosomal aber-rations in lymphocytes predict human cancer independentlyof exposure to carcinogens European Study Group onCytogenetic Biomarkers and Health

Cancer Research

2000

60

1619ndash162536 Tucker JD Preston RJ Chromosome aberrations micronuclei

aneuploidy sister chromatid exchanges and cancer riskassessment

Mutation Research

1996

365

147ndash15937 Hauptmann M Lubin JH Stewart PA Hayes RB Blair A

Mortality from lymphohematopoietic malignancies amongworkers in formaldehyde industries

Journal of the NationalCancer Institute

2003

95

1615ndash162338 Pinkerton L Hein M Stayner L Mortality among a cohort

of garment workers exposed to formaldehyde an update

Occupational and Environmental Medicine

2004

61

193ndash200

39 Coggon D Harris EC Poole J

et al

Extended follow-up ofa cohort of British chemical workers exposed to formaldehyde

Journal of the National Cancer Institute

2003

21

1608ndash161440 Bertazzi PA Pesatori AC Radice L Zocchetti C Vai T

Exposure to formaldehyde and cancer mortality in a cohortof workers producing resins

Scandinavian Journal of WorkEnvironment and Health

1986

12

461ndash46841 Hauptmann M Lubin JH Stewart PA Hayes RB Blair A

Mortality from solid cancers among workers in formaldehydeindustries

American Journal of Epidemiology

2004

159

1117ndash1130

42 Blair A Stewart P OrsquoBerg M

et al

Mortality among indus-trial workers exposed to formaldehyde

Journal of theNational Cancer Institute

1986

76 1071ndash108443 Gardner MJ Pannett B Winter PD Cruddas AM A cohort

study of workers exposed to formaldehyde in the Britishchemical industry an update British Journal of IndustrialMedicine 1993 50 827ndash834

44 Hayes RB Blair A Stewart PA Herrick RF Mahar HMortality of US embalmers and funeral directors AmericanJournal of Industrial Medicine 1990 18 641ndash652

45 Collins JJ Esmen NA Hall TA A review and meta-analysisof formaldehyde exposure and pancreatic cancer AmericanJournal of Industrial Medicine 2001 39 336ndash345

46 Pashley EL Nelson R Pashley DH Systemic distribution of14C-formaldehyde with formocresol-treated pulpotomy sitesJournal of Dental Research 1980 59 603ndash608

47 Myers DR Shoaf HK Dirksen TR Distribution of 14C-formaldehyde after pulpotomy with formocresol Journal ofthe American Dental Association 1978 96 805ndash813

48 Zarzar PA Rosenblatt A Takahashi CS Takeuchi PL Costa

206 C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

LA Jr Formocresol mutagenicity following primary toothpulp therapy an in vivo study Journal of Dentistry 2003 31479ndash485

49 Messer LB Cline JT Korf NW Long-term effects of primarymolar pulpotomies on succedaneous bicuspids Journal ofDental Research 1980 29 116ndash123

50 Waterhouse PJ A comparison of the relative efficacy offormocresol versus calcium hydroxide as vital pulp therapyagents in primary molars PhD Thesis Newcastle upon TyneUniversity of Newcastle upon Tyne 2000

51 International Agency for Research on Cancer Press releaseno 153 15 June 2004 [WWW document] URL httpwwwiarcfrpagerootPRELEASESpr153ahtml

52 National Pathways Association NPA definition of a pathwayof care NPA Newsletter 1998 Spring 2

53 Currie L Harvey G The Origins and Uses of Care Pathwaysin the USA Australia and the United Kingdom Report No 15London RCN Institute Oxford Centre Royal College ofNursing 1997

54 Hale C Issues in the evaluation of multidisciplinary pathwaysof care In Wilson J (ed) Integrated Care Management The Pathto Success Oxford Butterworth-Heinemann 1987 281ndash296

55 de Luc K Care pathways an evaluation of their effectivenessJournal of Advanced Nursing 2000 32 485ndash496

56 Currie L Care pathways development and implementationNursing Standard 1998 12 35ndash38

57 Goel V Decision analysis applications and limitationsCanadian Medical Association Journal 1992 147 413ndash417

58 Richardson WS Detsky AS Usersrsquo guides to the medicalliterature VII How to use a clinical decision analysis Arethe results of the study valid Journal of the American MedicalAssociation 1995 273 1292ndash1295

59 Ibricevic H Al-Jame Q Ferric sulfate as pulpotomy agent inprimary teeth twenty month clinical follow-up PediatricDentistry 2000 24 269ndash272

60 Ibricevic H Al-Jame Q Ferric sulphate and formocresol inpulpotomy of primary molars long term follow-up studyEuropean Journal of Paediatric Dentistry 2003 4 28ndash32

61 Casas MJ Kenny DJ Johnston DH Judd PJ Long-term out-comes of primary molar ferric sulfate pulpotomy and rootcanal therapy Pediatric Dentistry 2004 26 44ndash48

62 Papagiannoulis L Clinical studies on ferric sulphate as apulpotomy medicament in primary teeth European Journalof Paediatric Dentistry 2002 3 126ndash132

63 Salako N Joseph B Ritwik P Salonen J John P Junaid TAComparison of bioactive glass mineral trioxide aggregateferric sulphate and formocresol as pulpotomy agents in ratmolar Dental Traumatology 2003 19 314ndash320

64 Casas MJ Kenny DJ Johnston DH Judd PL Layug MAOutcomes of vital primary incisor ferric sulphate pulpotomyand root canal therapy Journal of the Canadian Dental Asso-ciation 2004 70 34ndash38

65 Casas MJ Layug MA Kenny DJ Johnston DH Judd PLTwo-year outcomes of primary molar ferric sulphate pulpot-omy and root canal therapy Pediatric Dentistry 2003 25 97ndash102

66 Cleaton-Jones P Duggal M Parak M Williams S Setze SFerric sulphate and formocresol pulpotomies in baboonprimary molars histological responses European Journal ofPaediatric Dentistry 2002 3 121ndash125

67 Dominguez MS Witherspoon DE Gutmann JL OppermanLA Histological and scanning electron microscopy assess-ment of various vital pulp-therapy materials Journal of Endo-dontics 2003 29 324ndash333

68 Waterhouse PJ Whitworth JM Nunn JH Development of amethod to detect and quantify Prostaglandin E2 in pulpalblood from cariously exposed vital primary molar teethInternational Endodontic Journal 1999 32 381ndash387

69 Waterhouse PJ Nunn JH Whitworth JM Prostaglandin E2and treatment outcome in pulp therapy of primary molarswith carious exposures International Journal of PaediatricDentistry 2002 12 116ndash123

70 Tickle M Milsom K King D Kearney-Mitchell P BlinkhornA The fate of the carious primary teeth of children whoregularly attend the general dental service British DentalJournal 2002 192 219ndash223

71 Milsom K Tickle M King D Does the dental professionknow how to care for the primary dentition British DentalJournal 2003 195 301ndash303

72 Pendlebury ME Horner K Eaton KA (eds) Selection Criteriafor Dental Radiography 2nd edn London Faculty of GeneralDental Practitioners (UK) The Royal College of Surgeons ofEngland 2004

73 Fuks AB Bimstein E Kelin H Assessment of a 2 percentbuffered glutaraldehyde solution in pulpotomized primaryteeth of school children a preliminary report Journal ofPedodontics 1986 10 323ndash330

74 Mack RB Dean JA Electrosurgical pulpotomy a retrospec-tive human study Journal of Dentistry for Children 1993 60107ndash114

75 Agamy HA Bakry NS Mounir MMF Avery DR Comparisonof mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth PediatricDentistry 2004 26 302ndash309

76 Elliot RD Roberts MW Burkes J Phillips C Evaluation ofthe carbon dioxide laser on vital human primary pulp tissuePaediatric Dentistry 1999 21 327ndash331

77 Al-Zayer MA Straffon LH Feigal RJ Welch KB Indirectpulp treatment of primary posterior teeth a retrospectivestudy Pediatric Dentistry 2003 25 29ndash36

78 Hansen HP Ravn JJ Ulrich D Vital pulpotomy in primarymolars A clinical and histological investigation of the effectof zinc-oxide eugenol cement and Ledermix ScandinavialJournal of Dental Research 1971 79 13ndash23

206 C L Patchett V Srinivasan amp P J Waterhouse

copy 2006 BSPD and IAPD

LA Jr Formocresol mutagenicity following primary toothpulp therapy an in vivo study Journal of Dentistry 2003 31479ndash485

49 Messer LB Cline JT Korf NW Long-term effects of primarymolar pulpotomies on succedaneous bicuspids Journal ofDental Research 1980 29 116ndash123

50 Waterhouse PJ A comparison of the relative efficacy offormocresol versus calcium hydroxide as vital pulp therapyagents in primary molars PhD Thesis Newcastle upon TyneUniversity of Newcastle upon Tyne 2000

51 International Agency for Research on Cancer Press releaseno 153 15 June 2004 [WWW document] URL httpwwwiarcfrpagerootPRELEASESpr153ahtml

52 National Pathways Association NPA definition of a pathwayof care NPA Newsletter 1998 Spring 2

53 Currie L Harvey G The Origins and Uses of Care Pathwaysin the USA Australia and the United Kingdom Report No 15London RCN Institute Oxford Centre Royal College ofNursing 1997

54 Hale C Issues in the evaluation of multidisciplinary pathwaysof care In Wilson J (ed) Integrated Care Management The Pathto Success Oxford Butterworth-Heinemann 1987 281ndash296

55 de Luc K Care pathways an evaluation of their effectivenessJournal of Advanced Nursing 2000 32 485ndash496

56 Currie L Care pathways development and implementationNursing Standard 1998 12 35ndash38

57 Goel V Decision analysis applications and limitationsCanadian Medical Association Journal 1992 147 413ndash417

58 Richardson WS Detsky AS Usersrsquo guides to the medicalliterature VII How to use a clinical decision analysis Arethe results of the study valid Journal of the American MedicalAssociation 1995 273 1292ndash1295

59 Ibricevic H Al-Jame Q Ferric sulfate as pulpotomy agent inprimary teeth twenty month clinical follow-up PediatricDentistry 2000 24 269ndash272

60 Ibricevic H Al-Jame Q Ferric sulphate and formocresol inpulpotomy of primary molars long term follow-up studyEuropean Journal of Paediatric Dentistry 2003 4 28ndash32

61 Casas MJ Kenny DJ Johnston DH Judd PJ Long-term out-comes of primary molar ferric sulfate pulpotomy and rootcanal therapy Pediatric Dentistry 2004 26 44ndash48

62 Papagiannoulis L Clinical studies on ferric sulphate as apulpotomy medicament in primary teeth European Journalof Paediatric Dentistry 2002 3 126ndash132

63 Salako N Joseph B Ritwik P Salonen J John P Junaid TAComparison of bioactive glass mineral trioxide aggregateferric sulphate and formocresol as pulpotomy agents in ratmolar Dental Traumatology 2003 19 314ndash320

64 Casas MJ Kenny DJ Johnston DH Judd PL Layug MAOutcomes of vital primary incisor ferric sulphate pulpotomyand root canal therapy Journal of the Canadian Dental Asso-ciation 2004 70 34ndash38

65 Casas MJ Layug MA Kenny DJ Johnston DH Judd PLTwo-year outcomes of primary molar ferric sulphate pulpot-omy and root canal therapy Pediatric Dentistry 2003 25 97ndash102

66 Cleaton-Jones P Duggal M Parak M Williams S Setze SFerric sulphate and formocresol pulpotomies in baboonprimary molars histological responses European Journal ofPaediatric Dentistry 2002 3 121ndash125

67 Dominguez MS Witherspoon DE Gutmann JL OppermanLA Histological and scanning electron microscopy assess-ment of various vital pulp-therapy materials Journal of Endo-dontics 2003 29 324ndash333

68 Waterhouse PJ Whitworth JM Nunn JH Development of amethod to detect and quantify Prostaglandin E2 in pulpalblood from cariously exposed vital primary molar teethInternational Endodontic Journal 1999 32 381ndash387

69 Waterhouse PJ Nunn JH Whitworth JM Prostaglandin E2and treatment outcome in pulp therapy of primary molarswith carious exposures International Journal of PaediatricDentistry 2002 12 116ndash123

70 Tickle M Milsom K King D Kearney-Mitchell P BlinkhornA The fate of the carious primary teeth of children whoregularly attend the general dental service British DentalJournal 2002 192 219ndash223

71 Milsom K Tickle M King D Does the dental professionknow how to care for the primary dentition British DentalJournal 2003 195 301ndash303

72 Pendlebury ME Horner K Eaton KA (eds) Selection Criteriafor Dental Radiography 2nd edn London Faculty of GeneralDental Practitioners (UK) The Royal College of Surgeons ofEngland 2004

73 Fuks AB Bimstein E Kelin H Assessment of a 2 percentbuffered glutaraldehyde solution in pulpotomized primaryteeth of school children a preliminary report Journal ofPedodontics 1986 10 323ndash330

74 Mack RB Dean JA Electrosurgical pulpotomy a retrospec-tive human study Journal of Dentistry for Children 1993 60107ndash114

75 Agamy HA Bakry NS Mounir MMF Avery DR Comparisonof mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth PediatricDentistry 2004 26 302ndash309

76 Elliot RD Roberts MW Burkes J Phillips C Evaluation ofthe carbon dioxide laser on vital human primary pulp tissuePaediatric Dentistry 1999 21 327ndash331

77 Al-Zayer MA Straffon LH Feigal RJ Welch KB Indirectpulp treatment of primary posterior teeth a retrospectivestudy Pediatric Dentistry 2003 25 29ndash36

78 Hansen HP Ravn JJ Ulrich D Vital pulpotomy in primarymolars A clinical and histological investigation of the effectof zinc-oxide eugenol cement and Ledermix ScandinavialJournal of Dental Research 1971 79 13ndash23