an evaluation of a chemical cautery agent and an anti-inflammatory ointment for the treatment of...

8/13/2019 An Evaluation of a Chemical Cautery Agent and an Anti-Inflammatory Ointment for the Treatment of Recurrent Ap

1/5

Oral edicine

An evaluation of a chemical cautery agent and ananti-inflammatory ointment for the treatment ofrecurrent aphthous stomatitis: A pilot study

Nelson L. Rhodus, D MD , MPH*/Janna Bereuter, BA**

Objective Recunem aphllious siomits is a very common condion, currently treated with anli-iiiflamiita-tory agents, which paltiaie the synipioms. The purpo.te o f this clinical trial was ta compare a medicatiancomm oniy used to treat recurrent aphthous stomatitis, Kenaiog-iii-Orabase. and a newer agent. DebacteroiMethod and materials Sixty patients diagnosed with recurrent aphrhous stomatitis were enrolled in thestudy. Twenty patients were assigned lo euch of the two treatment groups, and 20 age- a nd sex-mulched pa-tienis were assigned to the control group , which received no irealment. After the diagnosis was made, clini-ca l examinations and ulcer measurements were performed and a subjective evaluation of symptoms (00-mm visual analog scale) was completed by each subject. The subjects did not use any other medications.Both agents were applied topically (the frequency varied depending on the group of subjects) at specified in-tervals. Ulcer measurements an d subjective evaluations were made a t days 0. 3, 6, and 10 for all subjects. esults In both treatment groups, by day 10. 00 of the ulcers had clinically healed an d were no longercausing pain. Patients in the Debacteroi group reported a significaniiy greater decrease in painat 3 days (> 70 ) than did subjects in the other groups < 20 ), although the size of the ulcer did notdiffer significantly in any of the groups. After day 6. 80 of the ulcers in the Debacteroi group had clini-cally disappeared and no longer caused symptoms, as compared to about 30 in the other groups.Conclusion Patients su bjectively reported significantly greater relief from symptoms with Debacteroi thanwith Kenalog-in-Orabase or no treatment. The relief of symptoms associated with recurrent aphthous stom-atitis may or may not correspond to clinical improvement an d these tw o topical medications mayaffect signs and symptoms of the lesions differently. (Quintessence Int 1998;29;769-773)

Key words aphthous ulcer, chemical cautery, corticosteroid, lesion , recurrent aphthous stomaitis

Ciinical relevance

This article will help the dental clinician to recog-nize and treat recurren t aphth ous stom atitis, whichis a very common and painful prob lem for whichmany dental patients seek relief.

Recu r r en t ap l i t hous s t o ma t i t i s RAS) i.s the mos tcommon recurrent oral mucosal ulcerat ive condi-

tion in the world. '-^ This condition is characterized bypainfui, pesky, aggravating, oral ulcers, also known ascanker sores. Epidemiologie s tudies have indicated that

Associale Professor and Director. Division of Oral Medicine, Uni-versity of Minnesota. School of Dentistry, Minneapolis. Minnesota.

'Resea rch Coordinator. Minnesola Oral Heallt Research Center. Uni-versity of Minnesota, School of Denlisiry. M inneapolis. Mitiresota.

ReprinI requests Dr Nelson L. Rhodus. Associate Professor and Direc-tor Division of Oral Medicine, University of Minnesota, School of Den-tistry 7-536 Moos Health Sciences Tower, 515 Delaware Slreet SE.Minneapolis. Minnesota 55455. E-mait: [email protected]

as much as 2 5 % of the general pop ulation suffers p eri-odically from this troublesome problem.''^

Recurrent aphthous stomatitis is characterized hy singleor multiple, sometimes coalescing, and always p ainful ul-crations of the oral mucosa. Typically die ulcers are small(2 to 4 mm in diameter, termed minor aphthae) and shallow,have a gray-yellow psuedomembrane, and are surroundedby an erythematous halo. These ulcers appear on the fluc-tuant, nonkeradnized or less keratinized) oral mucosal ds-sues and usually regress spontaneously within 14 days.

However, major aphthae, wtiich may approach 8 to 10mm in diameter, may occur and are mu ch mo re painful.'' 'These major aphthae also require a much longer healingperiod. The presence of multiple major aphthae ean benearly debil i ta t ing for affected ind ividu als. In certainpat ients , the ulcers are large and very p ainful, ten d toheal very slowly, and are present almost continuously.This situation, of eourse, results in significant discom-fort, especially during eating, chewing, and speaking.^-'

A third form of RAS is the herpe t i form type , inwhich the lesions are usually multiple, may be coalesc-

ing, and resemb le herpes simp lex viral lesions.'-' 'T h e e t i o i o g y of RAS is u n k n o w n . The l e s i o n s

Quintessence International7 9

OralMedicine

\.$"'-IE-SEEK

An evaluationof a chemicalcauteryagent and an G ? t ianti-inammatory ointmentfor the treatmentofrecurrent aphthous stomatitis:A pilot study E

1 ; -J

2 : 5 M a t i n g ?

Nelson L. Rhodus. DMD. MPH*iJanna Bereuter. BA**

Ohjetivi Reftttteitt aphthaiis stoniatitis is a l ' t t_icoiniitoti condition. t ' . ' t t t t 'iE t i t i_itreated with anti-iitaiiiiiiato- i f - . 'agents. which paiiiate the syiiiptoins. The piir_oa.~ieofthis ciinicai trial was ta compare a itiedicatioiicainnioiiiy used ta treat reciirreiit aphthoiis staniatitis.ifeiiaiag-iii-Urahase. and a neirer agent. Dehacteroi.Method and materials: .S i . i ' t_vpatients diagiio.i 'edwith recurrent aphthoiis stainatitis were enrolled in thesaidy. iii- eiity patients were assigned to each of the two treatnieiit groups. and 20 age- and se.r-matchedpa-tients were assigned to th e raiitroi group. i t-*ii i i1itrer.'eii=edno treaniteiit.tler the rh 'ag iiasi 's was ntade .clini-cai exaiitinatiatts and iiicer rneasiireineittsirere perfoniied. and a siiibjectii-eeiiriiiiatiaii ofsi iiiptoiiis (IOU-rnin visual analog scaiel w as conipieted hr each siihject.Ti - i esiihiectsdid not use a ny other iiiedicatiatis.Both agents were appiied topi'criii_'-.'ithefreatieitey varied depeiiditig an the group afsiihjects,l at spec ied in -tervals. Uicer ineasttrenientsand . ' i i t i?_ii i I i l - evaiaatiaiis w e re m a deat a a _ i sU . 3, ti. a nd i Ufoi"all siihject.r.Results: in hath treatment groups. by day i U . i r II t0=i:~of the tiicers ha d ciiiiicaiiy heated and w ere n olongercatisaig pain. Patients in the Dehacteroi gtattp re_i:iarted asigiiificaiitty greater decrease in painat 3 days i1 1 >i U '5 i :_ lthan did s t i i1_ie t ' . ' t sin the other giotips t < 1Z U C F E - j .aititoiigh the s i _ ' j eof the iticer did notdiffer sigttificattti_i'in tIl 'i_iof the gmttps. After da y t5 . 3 U i- t -of the iiicers in the Dehacterotgrotip had ciini-caiiy disappeareri and no longer caused. i ' _ i= t i t_ i : I ta i i t s .as caiit_nrii'edto about 3Uiin the other grait_ns.Conclusion: Patients stih_iet'tit=eiyreported sigiti-caitti_i=greater i'eiie_f_,'aitisji'iiiptriiit.i'with Dehacteroi thanwith Kenaiag-in-Orahase or no trea tmen t.Th e reii 'efafs_i'niptanisri.i'sot'iatedwith iecitireittaphthatisstain-atitis niajror n t a _ vnot correspondto ciiiiicai ittttifll-'l'ittii,and these two topicai inedicatioiis ma yaect sigiis and svinptoiiis of the iesi'ons diTj f le i e i i t i_ - i~ .{QuintessenceInt l99S:29:?69??3l

Key words: aphthous ulcer. chemical cautery. corticosteroid. lesion. recurrentaphthous stomatitis

Clinical relevance

This article will help the dental clinician to recog-nize and treat recurrentaphthous stomatitis.whichis a very comtnon and painfulproblemfor which

many dentalpatients seek relief.

Recurrent aphthous stomatitis {RASJ is the mostcommon recurrent oral mucosa] uicerative condi-

tion in the worid.'"3This condition is characterizedbypainful. pesky. aggravating,oral ulcers. also known ascanirerso-res. Epidemiologic studies have indicatedthat

*etssociate Professor and Director.Divisionof U ra l M e dic in e. U ni-versityof Minnesota.School of Dentistry. Minneapolis.Minnesota-

esearch Coordinator. MinnesotaOral Health Research Center. Uni-versityof Minnesota.School of Dentistry. Minneapolis.I t l1HE5iJ1 i1-

Reprint requests: Dr Nelson L.Rhodus. Associate Professorand Direc-tor. Divisionof OralMedicine. Universityof Minnesota. Schoolof Den-tistry ?-536 Moos Health Sciences Tower. 51 5 Delaware StreetSE .MinneapolisMinnesota55455.E-mail:[email protected]

QuintessenceInternational

as much a s 25 % of the g en er alpopulation suffers peri-odically from this troublesomeproblem.-3

Recurrentaphthous stornatitisis characterizedby singleor multiple.sometimes coalescing.and alwayspainfulul-cerationsof the oral mucosa. Typicallythe ulcers are stnall(2 to 4 mm indiameter. termediniiiar aphthae)and shaow.have a gray-yellowpsuedomembrarie.and are surroundedby an eryilietnatoushalo. These ulcers appear on the uc-tuant. nonkera tin ized lorless keratinizedji oralmucosa] tis-sues atid usuallyregress spontaneouslywithin1 4 days.

However.major aphthae. whichmay approach 8 to 10mm in d iamete r. mayoccur and are much more painful.-5These major aphthae also require a much l onger hea lingperiod. The presence of multiple major aphthae can benearly debilitating for affected individuals. In certainpatients. the ulcers are la rg e a nd very painful. tend toheal very slowly. and are present almost continuously.This situation. of course. results in signicant discom-fort.especiallyduringeating.chewing.and speaking?-i

A third form of RAS is the herpetiform type. inwhich the lesions are usually multiple. may be coalesc-itig. and resemble herpes simplexviral lesions?"i

The etiology of Rt-XS is unknown. The lesions

? E i 9


2/5

Rhodus/Bereuter

demonstrate characteristics of an altered imtnunologic(T-cell lytnphocyte) response. Associations with sys-temic disease such as diabetes mellitus, inatnmatorybowel disease or other gastrointestinal disturbances,anemia, and immttnosuppression have beeti reported.Precipitating factors include stress, trauma, allergies,

hormonal alterations, nutritional inadequacies, and in-fectious agents (eg, human immunodeficiency virus).-^The treatment for RAS historically has been palliative

and relatively unsuccessful, usually only partially reliev-ing the symptoms.*-'-' Other than topical anesthetics, suchas benzoca ine. anti-inflammatory ointments, applied tothe oral mucosa much the same as on skin, are used topalliate the pain and reduce symptoms. Probably themost widely recommended agents have been preparationsof hydrocortisone and triamcinolone acenotinide 0.1%(Kenalog, Apothecon), which are applied top ica lly.' '''

The puipose of this clinical trial was to compare amedication commonly used for RAS treatment, Kena-log-in-Orabasc and Debacterol (Northern ResearchLaboratories). Debacterol is a commercially availablechemical cautery agent, consisting of 50% sulfuric acidand 28% sulfonated phenolics in aqueous solution. Therationale for use of this agent is that it cauterizes the ep-ithelial tissue affected by the immune response.

Method and materials

For this sttidy, a subject population of 60 individuals wasenrolled. There were 20 patients (16 female and fourmale) in each of three groups (Debacterol [D] treatment;Kenalog-in-Orabase [KO] treatment; and control [C],which was no treatment). The mean age was 37.3 years.

A definitive diagnosis of RAS was made by a singleexperienced, calibrated clinician based on the classicclinical presentation of RAS (ie, a relatively shallow,p s eu dome m bran ou s, gray-yellow ulcer with a surround-ing erythematous halo, found on the less kcratinized ornonkeratinized mucous membranes of the oral cavity).

For the patient to be enrolled in the study, the RASulcer had to be less than 48 hours old (that is, from thetime the subject had first noticed it).

The subjects were generally healthy adult volunteerswith no major medical diagnoses and who had not beenmedicated with antibiotics, anti-inammatory agents, oranalgesics within 2 weeks of the study. Smokers wereexcluded from participation.

Clinical assessments of all subjects were made at days0, 3, 6, and 10. The maximum diameter of the ulcer andthe erythematous halo was measured with a periodontalprobe (Fig 1}. These m easurements were made by thesame experienced, calibrated clinician at days 0, 3, 6, and10, or until the ulcer had clinically healed.

Subjective evaluation of the subject's symptoms wasalso made at days 0, 3, 6, and 10. The subject's percep-tion of pain from the ulcer was recorded on a iOO-tnmvisual analog scale (VAS) in which 0 represented nopain and 100 represented the worst pain imag inable.

The test agents were applied topically to the lesions

at specified intervals. After the surface of the lesion wasdried thoroughly, Debacterol was applied to the ulcer-ated mucosa, a single time, directly over the margins(including the halo) of the ulcer for a period of exactly10 seconds (Figs 2 and 3). The area was then thoroughlyflushed with water and dried thoroughly with a cotton-tipped applicator Kenalog-in-Orabase was applied liber-ally over the ulcer three times every day by the subject.Subjects were instructed in the proper use of KO.

The control subjects were evaluated precisely in thesame manner but received no treatment.

The subjects did not use any other medications dur-ing the study period.

Results

Figures 4 to 8 indicate the degree of healing and reep-ithelialization of representative aphthae after treatmentwith Debacterol.

The size of the ulcers had not changed significantlyin any of the groups by day 3 (Table and Fig 9). How-ever, a significant decrease in the VAS (Table 2 and Fig

10) in the D group at day 3 indicated a significant im-provement in pain (> 70%) compared to the KO group(< 20%) and the C group (> 30%).

By day 6, 70% of the ulcers had clinically disap-peared, and there was resolution of symptoms in 100% ofthe subjects in the D group. Only 30% of the lesions haddisappeared in the KO and C groups. In a few individualsin the KO group, there was a significantly greater de-crease in the clinical measurement (ulcer size) over the Dand C groups, but the VAS revealed no significant changein the perception of pain among these patients.

By day 10, 100% of the ulcers had clinically healedand were causing no pain in both treatment groups (Dand KO). At day 10, 10% of the control group still hadclinical ulcers present, with an average VAS of 18 mm.

iscussion

Treatment for recurrent aphthous stomatitis has tradi-tionally been palliative and/or has involved anti-infiam-matory agents. Topical steroids and chemical cauteryagents have been used previously to treat oral mucosaldisorders, such as RAS, with limited success. At thepresent time, the treatments available have been largelyunsuccessful.

77 0 Volume 29 Number 12

.._ _ _ __

Flhodustdereuter

demonstrate characteristicsof a n altered immunologictT-cell lymphocyte} response. Associations with sys-temic disease such as diabetes inellitus. inammatorybowel disease D 1 other gastrointestinal disturbances.aneiti ia.and imnuinosuppression have been reported.Prccipitatiiig factors include stress. t rauma. allergies.

hormonal alterations. iititritional inadequacies.and in -fectious a g e iits le g . h um a nimmunodeciency virusirlr

The treatment for RAS historically has been palliativeand relativelyunsuccessful.usually on ly par tia l lyreliev-in g the symptoms.*"-Otherthan topicalanesthetics. suchas benzocaine.anti-inflaniinatory ointinents.applied tothe oral mucosa much the same as on skin. a re use d topalliate the pain and redtice symptoms. Probably themost widely recommendedagents have been preparationsof hydrocortisone and triamcinolone acenotinide (1.1%llienalog. Apothccon}.which are appliedtopicallj-ll-1"

The puipose of this clinical trial w as to compare amedication commonly used for RAS treatment. Rena-log-in-Orabasc a nd Debacterol (Northern Re-searchLaboratories]. Debacterol is a commercially availablechemica l cau te iyagent. consisting of 50% stilfuric acidand 28 % sulfonatedphenolics in aqueous solution. Therationalefor use of this agent is that it cautcrizesthe e p-ithelial t issuc affectedby the imtnune response.

Method and materials

For th is study. a subject poptilation of 60 individualswasenrolled. There were 2 0 p a tie n ts (lo female and fourmale] in each of three groups [Debacterol[D] treatment;Kenalog-in-Orabase [KO] treatment; and control [C].which was no t rea tment} . Themean age was 313 years.

A denitive diagnosis of RAS w as m ade by a singleexperienced. calibrated clinician based on the classicclinical presentation of RAS tie. a relatively shallow.pseudomembranous.gray-yellow ulcer with a sttrround-ing erythematous halo. found oi t the le ss kcratinixedornonkerat inizcdmucous membranes of the oral cavity].

For the patient to be enrolled in th e s tud y. the RASulcer ha d to be less than 4 8 hours old (that is. from thetime the subject ha d rst noticed it).

The subjects were general lyhealthy adult volunteerswith no major medicaldiagnoses and w ho ha d not beenmedicated with antibiotics. anti-inflammatory agents. oranalgesics within2 weeks of the study. Smokerswereexcludedfrom participation.

Clinical assessments of a ll subjects weremade at daysU . 3 . 6 .and 1 0 .The maximumdiameterof t h e ulcer andthe erythematous halow a s m ea sur ed with a periodontalprobe [Fig 1}. These measurements w ere made by thesame experienced.calibratedclinician at days U .3 . 6. and10. or until the ulcer ha d clinically healed.

TFO

Subjective evaluationof the subjects S}* '1Tip l i -its W 3 5also made at days O . 3 . 6. and 10. The subjects i J ' ~ 1 T ' 3tion of pain from t h e ulcer was recorded on a IUU-Illmvisual analog scale WAS} in which 0 represented nopain and IOUrepresentedthe worstpain imaginable .

The test agents were applied topically to th e le sion sat specied intervals .After the surface of the lesion wasdried thoroughly.Debactcrolwas a p plie d to the ulcer-ated mucosa. a single t ime. directly over th e m a rg in s(including the halo}of the ulcer for a period of exactly10 seconds [Figs 1 1and 3 }.The area was then thoroughlyflushed with water and dried thoroughlywith a cotton-t ipped appl icator.Kenalog-in-Orabasewas applied liber-ally over the ulcer three times e ve ry d ayby the subject.Subjec ts wereinstructed in the proper use of KO .

The control subjects were evaluated p re c is e ly inthesame mannerbtit receivedno treatment.

The subjects did not use any other medica tionsdur-in g the study period.

Results

Figures = 1to 8 indicate the degree of healing a nd re ep-ithelialiration of representativeaphthae after treatmentwith Debacterol.

The size of the ulcers ha d not changed signicantlyin any of the groups by day 3 {Table l and Fig 9}. H o w -ever. a signicant decrease in the MAS {Table2 and Fig

10} in the D grotip at day 3 indicateda significant im-provement in pain t> ' iU%)compared to the KO group(_ 30%) .

By da y 6. toss of the ulcers ha d clinically disap-peared. and there was resolutionof symptoms in lUU%ofthe subjects in the D group. Only 3 0% of the lesions ha ddisappearedin the KO and C groups. In a fe w individualsin the KO group. there was a signicantly greater de -crease in the clinical measurement(ulcersize] over the Dand C groups . but the VAS revealedno signicantchangein the perceptionof pa in a m on gthese patients.

By day IO . l0-0% of the ulcers had clinically healedand w e re c ausin gno pain in b oth tr ea tm e n tgroups [Dand KO}.At day IO . 10% of the control group still ha dclinical ulcers present. with an average VAS of 18 mm.

Discussion

Treatment for recurrent aphthous stomatitis ha s tradi-tionally been palliative andiorha s involvedanti-inflam-matory agents. Topical steroids and chemical cauterya ge nts ha ve b ee n usedpreviously to tr ea t or al m uc osa ldisorders. such as RAS. with limited success. At thepresent time. the treatments availablehave been largelyunsuccessful.

volume 29. Number 1 .2 . 1 *-3 9 5


3/5

Rhodus/Bereute

ig Aphthous ulcer prior to treatment withDebacterol. A periodontal probe is used tomeasure ulcer size by 1) maximai diameter,including the erythematous haic zone and 2)perpendicular to maximai diameter

ig 2 Aphthous ulcer being dried with a ig 3 Aphtho us ulcer being treated withcotton-tipped applicator Debacteroi, applied for 10 seconds. After

application, the area is thoroughly rinsedwith water and dried.

Fig 4 Aphtho us ulcer immed iately after ig S Aph thcus ulcer treated with De-treatment with Debacterol Note the zone of bacterok Day 1. Healing is evidenced by ini-epithelial cauteriza tion. tial reepitheliaiization

ig 6 Aphthous ulcer treated with De-bacteroi Day 2. Healing is evidenced by

progressing reepitheliaiization.

ig 7 Aph thous ulcer treated withDebacterol: Day 3. Healing is evidenced byprogressingreepithelialization.

Quintessence International771

F l h c d u a f E i e r e u t e r

Fig 1 Aphthous ulcer priorto trea tment wi thDebacterol.A per iodonta l probeis use d tomeasure ulcer siz e bv (U maximal diameter,includingthe erythematoushalo zone and {2}perpendicularto maximal diameter.

Fig ll aphthous ulcer immediatclv aftert rea tment wi thDebacterol. Note the z on e ofepithelialcauterization.

Fig 2 aphthous ulcer being dried with acotton-tippedapplicator.

Fig 5 aphthous ulcer treated with De -bactercl:Da v t. Heeling is evidenced b v in i-tial reepithelializaticn.

Fig ? aphthous ulc er tr ea te d withDebacterol:Da v 3 . Healingis evidenced bvprogressing reepithelializatic-n.

Fig 3 P-tpltthous ulcer being treated withDebacterol, applied for 10 seconds. Alte rapplication,th e area is thoroughlvrinsedwi th wa te rand dried.

Fig -E aphthous ulcer treated w ith De-bactercl: Da v 2. Heal ing is evidenced byprogressingreepitheltalization.

DuintessenceInternationalT/ '?1


4/5

Rhod US/Bereuter

TA B L E 1 Changes in ulcer size in subject groups(maximum diameter break in mm x 10)

Day Ulcer size-D56.9 16.t46.5 7.8

7.8 4.7Healed

Ulcer size-KO42.8 18.433.9 14.324.8+ 8.2

Healed

tjioer size-C59.1 15.649.9 18 8

28.4 1437.6 3.3

SigniticanceNSN S

P c 0 . 0 0 1

P < 0 . 0 0 1 -

D = De bac e rol; KO = Ka na og-in-Ora base; C = control (no ireatmert).'Signifie a nee, by Sluderl's (test , ot Debacteiol oveiKenalog-in-Orabase and no treatment."Significance, by SiLdenl's Itest, of Debacterol and Kena og-in-Orabase over no freatrrent.

TABLE 2 Cbanges in pain symptoms in subject groups, using tbe 100-mmvisual analog scaie (VAS)

D ay VAS-D56.4 18.111.4 7.8No painNo pain

VAS-KO52.2 18.437.9 14.320.8 8.3t o pain

VAS-C58 9 18.639 7 15.823.4 12.3

3.6 1.3

SignificanceN S

P< 0.001 'P < 0.001 *P< 0.001"

D = Debaclerol; KO = Kenalog-in-Orabase: C = ccntroi (no trealmenl).'Signiticance, by Student's (test, of Debacteroi orerKenalog-in-Oratiase and no treatment."Significance, by Sludent's Itest, of Debacleroi ancf Kenalog-in-Orabase over no freafmert.

Fig 9 Objective measurement of RAS ulcer size by day followingtreatment. Scores are reported in mm -10 (eg. 4.4 mrn ulcer 44). By day 6. ttie Debacterol group ulcer size iiacJ been reducedto approiimateiy one tiiird compared to ttie Kenalog and controlgroups. By day 10, the ulcers in botii the Debacteroi and Kenaioggroups had completely heaied, unlike those in the control group.

Fig 10 Subjective euaiuation of RAS uicer pain with a visual ana-log scaie score by day Icilcwing treatment. Scores are reported inmm (maximum = 100 mm). By day 6, ttie subjects in the De-bacteroi group had no pain, m contrast to patients in the Kenalogand control groups.

Recently. BJnnie et al'-^ published the results of threemulticentered ciitiical trials demotistratitig the efficacy ofAphthasol (Block Dnig) (5 atnlexanox) paste. In thatparticular study, after 3 days of treatment with the 5Aml exa nox , 2 1 of the RAS lesions had clinica llyhealed and 44 of the subjects had resolution of paitifulsymptoms In the present pilot .study of Debacterol (whichhad a much smaller number of subjects), aer 3 days oftreatment, approximately the same number of RAS le-

sions had completely healed, but the VAS indicated thatthere was more thati 70 resolution of pain. Likewise,after 6 days of treattnent, more than 70 of the lesionstreated with Debacterol had completely healed, and reliefof pain was complete in 100 of the subjects. This can becompared with the results with 5 Amlexanox pastewhere after 6 days, approximately the same percentageof RAS lesions had healed, but there was complete reso-lution of pain in only 68 of the subjec ts. ''

772 Volume 29, Number 12,

F 1h o d 1 . 1 s r ' E 1 e r e u t e | '

Da y UlcersizeD Ulcersizel < 1 U 'teg. rte-mm ulcer =- 11 : 11 .By day 6. the Debacterol groupulcer S I Z E ha d been reducedto approximatelyon e third comparesto the K en alog a nd c on tr olgroups Hy day 1 D , tne utcers in both the Debac te rol andr


5/5

Rhoous B ereuter

The study of 5 Amlexanox was indeed muchlarger; it reported results of 1,124 stabjects. comparedwith only 60 patients in the presetit study. The results olthe present pilot study mtist be interpreted in that coti-text. This clinical trial, in a small tittmber of subjects,demonstrated the effectiveness of a chemical cauteryagent. Debacterol, in relieving the symptoms of and ex-pediting healing in RAS lesions. Compared with otheragents presently available for the treatment of RAS,Debacterol shows promise in expediting the healing ofthe RAS ulcer.

onclusion

The results itidicated that immediate and significantrelief of the pain accompanying RAS was achieved in alarge majority of subjects with RAS through the use ofDebacterol as compared to Kenalog-in-Orabase or notreatment. The clitiical healing of the RAS ulcers wasalso expedited with the use of Debacterol as comparedto Kenalog-in-Orabase or no treatment, although thisdifference was not quite as dramatic as the symptomaticr li f The results indicated that relief of the symptomsaccompanying RAS may or may not correspond to clin-ical improvement and that these two topieal medicationsmay affect signs and symptoms of R S differently.

Further research is presently being conducted tohistologically investigate the epithelial wound-healing

process (of rabbit mucosa) after treatment with De-bacterol and Kenalog-in-Orabase.

eferences

1. Kleinman DV, Swango PA. Niessen LC. Epidemioiogic studiesof oral mucosa conditions: Methodoiogic issues. CommunityDent Orai Epidemiol 1991 ;19 :i2 9-l4 0.

2. Ship 11, Morris AL. Du rocher RT, Burket WL. Recurrent aph-thous uicerations in a profes.sional school student population.Oral Surg Oral Med Oral Pathol i96i:i4:30-39.

3. Ship II. Epidem iologie aspects of recurrent aphthous ulcrations.Oral Surg Oral Med Oral Pathoi 1972;33:4011-106.

4. Wray D. Graykowski EA, Notkins AL. Role o f mucosal injury inini t iat ing recurren t aphth ous s toma ti t is Br Med J 1981;283:1569-1570.

5. Ship J. Recurreni aphthous stom atitis. An update. Oral Surg OralMed Oral Pathol 1996;81:i41-146.

6. Scully C, Porter SR. Recurrent aphthous stomatitis: Current con-cepLs of etiology, pathogcnesis and management. J Oral PatholMedl989; l8 :21-27 .

7. MacPha il LA, Greenspan D, Greenspan JS. Recurrent aphthousulcers in association with HIV infections: Diagnosis and treat-ment. OrdI Surg Oral Med Oral Pathol 1992:73:283-288.

8. Lozada -Nur F. Huang M Z, Zhou G. Open preliminary clinicaltrial of clobetasol propionate ointment in adhesive paste fortreatment of chronic oral vesiculoerosive diseases. Oral SurgOral Med Oral Pathol 1991,71:283-287.

9. Brown RS . Bottomley W K. Com bination i m munosup pressantand topical steroid therapy for treatment of recurrent major aph-thae. Oral Surg Oral Med Oral Pathol 1990;69:42^l4.

10. Rattan J, Schneider M, Arber N, Gorsky M, Dayan D. Sucralfatcsuspension as a treatment of recurrent aphthous stomatitis.J Intem Med 1994:236:341-343.

11. Taylor LJ. Walker DM, Bag J. A clinical trial of prostaglandinE2 in recurrent aphthous ulcrat ion. Br Dent J 1993;I75:123-129

12. Meiller TR Kutcher MJ, Overhosler CD. Niehaus C, DePaoiaLG. Siegel MA. Effect of an antimicrobial mouth rinse on recur-rent aphthous ulcrations. Oral Surg Oral Med Oral Pathol 1991;72 :425^29 .

13. Vincent SD. Lilly GE. Clinical historic and therapeutic featuresof aphthous stomatitis. Oral Surg Oral Med Oral Pathol 1992:74:79-86.

14. Santis HR. Aphthous stomatitis and its management. Curr OpinDent 1991:1:763-768-

15. Binnie WH, Curro FA. Kliandwala A. Van Inwegen R. Amle-sanox oral pasle: A novel treatment that accelerates the healingof aphthous ulcers . Compend Contin Educ Dent 1997:18:1116-1126.

Quintessencelnternational77

Hl1oousj'Bereuter

The study of 5% Amlexanox w a s indeed touchlarger : it reported results of 1.124 sub jec ts . comparedwith only 60 patients in the present s tudy.The resu ltsofthe present pilot s tud y m us t be interpretedin that con-text. This clinical trial. in a sm a ll n um be rof subjects.demonstrated the effectivenessof a chemical cauteryagent. Debacterol.in relieving the symptoms of and ex-p ed itin g h ea lin g inRAS lesions. Compared with otheragents presently available for the t reatment of RAS.Debacterolshows promise in e xp e ditin gthe healing ofthe RAS nicer.

Conclusion

The results indicated that immediate and significantrelief of the p a in a c com pa n yin g R ASwas achieved in alarge majority of subjects with R AS th ro ug hthe use of

Debacterolas

compared to Kenalog-in-Orabaseor notreatment.The clinical healing of the RAS ulcers wasalso expedited with the use of Debacterolas comparedto Kenalog-in-Orabase or no treatment. although thisdifferencew as not quite as dramat ica s the symptomaticrelief.The results indicatedthat relief of the symptomsaccompanyingRAS may or ma y not correspond to clin-ieal improvementand that these tw o topicalmedicationsmay affect signs and symptoms of RAS differently.

Further research is presently being conducted tohistologically investigate the epithelial wound-healing

process {of rabbit mucosa} after treatment with De-bacteroland Kenalog- in-Orabase .

References

1 . KleinmanD v ' .Swango PA. Hiessen LC . Epidemiologicstudiesof oral mucosa conditions: fvlethodologicissues. CommunityDent OralEpidemiol1 9 9 1:l9:1'~. 9|-if].

DuintessenceInternational

"1

3.

- '1 .

5.

1 .

T .

S .

9.

Ill

I1

12

1 3

14

15

Ship ll. MorrisAL. Durocher RT. BurltetW L. Recurrentaph-thotts ulcerations in a professional school s tudentpopulation.UralSurg ClralMed Oral Pathol 1 9 6 1: 1 - 1 : 3 11 - 3 9 .Ship ll. Epiderniologicaspects of recurrentaphthous ulcerations.Ora lSurg CtralMed Oral Pathol 19?1:3?-:4llil-41115.Wr a yD. C i r a y l- z o w s l - tiE A. NotltinsAL . Role of mucosal injuryininitiating recurrent aphthous stomatitis. Br M ed 1981:23311559-l5r ll.

Ship J . Recurrentaphthous stotnatitis. Anupdate. Ural Surg CtralMed Ural Pathol l99t3;Sl:l41-I415.ScullyC. Porter SR. Recurrentaphthous stomatitis: Currentcon-cepts of etiology.pathogenesis and management. 1 Ural PatholMed l9E19;1E:2l-21.MacPhailL. - t .Greenspan D. GreenspanJ S . Recurrent aphthousulcers in association with Hl"vinfections: Diagnosis an d treat-ment. Ctral Surg C t r a l l' v 1 e 1 : lOralPatltol 1992;13:233-233.Ltncada-blurF . Huang M2. Zhou G . Open preliminary cl in ica ltrial of clobetasol propionateointment in adhesive paste fortreatmentof chronic oral vesiculoerosivediseases. Ural SurgUral lvled Ural Pathol I991 ;T"1:2S32S'i'.

Brown RS. EottomleyW K.Combinationirnrnunosuppressantan d topicalsteroid therapy for treatntentof recun'ent majoraph-thae. Dral Burg DralM ed O ra lPathol l99fl:Et9:-l-'1-'1-l.Rattan J . SchneiderM . Arber ls l .G Dl 'S l '-1}M . Dayan D. Sucralfatcsuspension a s a treatment of recurrentaphthous stomatitis.Jlntern M ed 1 9 9 - l . 3 3 t 5 : 3 - l1 3 4 3 .Taylor L.l. W allterDM . Ba g 1 . A clinicaltrial of prostagiandinE2 in recurrent aphthous ulceration. Br Dent .1 l99T1;l'r5:l2.1l29.

MeillerTF. Kutcher M]. CtverhoslerCD. Niehaus C. lJePaolaLG .Siegel l t v 1 A .Effectof a n antimicrobialmottth rinse on recur-rent aphthous ulcerations.DralSurg ClralMed Ural Pathol 1991;11:425-129.VincentSD. Lilly G E . Clinicalhistoric an d therapeuticfeaturesof aphthous stomatitis. Ctral Surg Clral Med ClralPathol 1992;1 - l i 'r ' l ' S f 1 .

S an tis H R .aphthous stornatitisa nd its tnattagement.Curr DpinDent l99l'.l:?63TeS.EiinnieW11. Curro FA. KhandwalaA. Va n lnwegen R. armle-xanox oral paste: A novel treatmentthat accelerates the healingof aphthous ulcers .Compenr lContin Educ Dent 1991118:I 1115-11213.

T73

an evaluation of a chemical cautery agent and an anti-inflammatory ointment for the treatment of...

Documents