ozone therapy for the treatment of dental caries

Ozone therapy for the treatment of dental caries (Review)

Rickard GD, Richardson RJ, Johnson TM, McColl DC, Hooper L

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library2004, Issue 3

http://www.thecochranelibrary.com

Ozone therapy for the treatment of dental caries (Review)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

http://www.thecochranelibrary.com

T A B L E O F C O N T E N T S

1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iOzone therapy for the treatment of dental caries (Review)


[Intervention Review]

Ozone therapy for the treatment of dental caries

George David Rickard1 , Robin J Richardson2 , Trevor M Johnson3, David C McColl4, Lee Hooper5

1Dorking, UK. 2Sutton Coldfield, UK. 3Yorkshire Area, Faculty of General Dental Practice, York, UK. 4Dental Surgery, Govan Hill

Health Centre, Glasgow, UK. 5School of Medicine, Health Policy & Practice, University of East Anglia, Norwich, UK

Contact address: George David Rickard, Old Sandstone Dental Practice, The Chine, Dorking, Surrey, RH4 1QT, UK.

[email protected].

Editorial group: Cochrane Oral Health Group.

Publication status and date: Edited (no change to conclusions), published in Issue 4, 2008.

Review content assessed as up-to-date: 13 May 2004.

Citation: Rickard GD, Richardson RJ, Johnson TM, McColl DC, Hooper L. Ozone therapy for the treatment of dental caries.

Cochrane Database of Systematic Reviews 2004, Issue 3. Art. No.: CD004153. DOI: 10.1002/14651858.CD004153.pub2.


A B S T R A C T

Background

Dental caries is a bacterially mediated disease characterised by demineralisation of the tooth surface, which may lead to cavitation,

discomfort, pain and eventual tooth loss. Ozone is toxic to certain bacteria in vitro and it has been suggested that delivering ozone

into a carious lesion might reduce the number of cariogenic bacteria. This possibly could arrest the progress of the lesion and may,

in the presence of fluoride, perhaps allow remineralisation to occur. This may in turn delay or prevent the need for traditional dental

conservation by ’drilling and filling’.

Objectives

To assess whether ozone is effective in arresting or reversing the progression of dental caries.

Search methods

We searched the Cochrane Oral Health Group’s Trials Register (to 7 November 2003); Cochrane Central Register of Controlled

Trials (CENTRAL) (The Cochrane Library 2003, Issue 3); MEDLINE and PREMEDLINE (OVID) (1966 to November 2003);

EMBASE (OVID) (1980 to November 2003); CINAHL (OVID) (1982 to November 2003); AMED (OVID) (1985 to November

2003). Quintessence was handsearched through 2002 and KaVo were contacted as manufacturers of the HealOzone apparatus for any

additional published or unpublished trials.

Selection criteria

Inclusion was assessed independently by at least two reviewers. Trials were only included if they met the following criteria: randomisation

in a controlled trial; single surface in vivo carious lesion accessible to ozone application; clear allocation concealment; ozone application

to the lesions in the intervention group; no such application of ozone in the control group; outcomes measured after at least 6 months.

Data collection and analysis

Reviewers independently extracted information in duplicate. A paucity of comparable data did not allow meta-analytic pooling of the

included studies.

1Ozone therapy for the treatment of dental caries (Review)


mailto:[email protected]

Main results

Three trials were included, with a combined total of 432 randomised lesions (137 participants). Forty-two conference papers, abstracts

and posters were excluded (from an unknown number of studies). The risk of bias in all studies appeared high. The analyses of all

three studies were conducted at the level of the lesion, which is not independent of the person, for this reason pooling of data was

not appropriate or attempted. Individual studies showed inconsistent effects of ozone on caries, across different measures of caries

progression or regression. Few secondary outcomes were reported, but one trial reported an absence of adverse events.

Authors’ conclusions

Given the high risk of bias in the available studies and lack of consistency between different outcome measures, there is no reliable

evidence that application of ozone gas to the surface of decayed teeth stops or reverses the decay process. There is a fundamental need

for more evidence of appropriate rigour and quality before the use of ozone can be accepted into mainstream primary dental care or

can be considered a viable alternative to current methods for the management and treatment of dental caries.

P L A I N L A N G U A G E S U M M A R Y

Ozone therapy for the treatment of dental caries

There is no evidence that ozone therapy can reverse or stop tooth decay.

Tooth decay can be painful, is expensive to treat and can lead to the loss of teeth. It has been suggested that treatment of a decayed

tooth with ozone will stop or reverse the decay process. This review of trials found no sound evidence that ozone is capable of reversing

or stopping the progression of tooth decay. High quality research is needed to show whether or not it works. Ozone should not be

considered an alternative to current treatment methods in dental practices.

B A C K G R O U N D

Dental caries is a multifactorial, bacteriologically mediated,

chronic disease that can damage the dentition of both children

and adults. Caries is widespread across all cultural groups and is

one of the most common diseases to affect the world’s population

(WHO 1990). Tooth decay accounts for almost half of all dental

extractions in the UK (NHS CRD 1999). However, patterns of

dental disease in the UK are changing (Kelly 2000), with less decay

being experienced by younger age groups. In the next two decades

there is likely to be a corresponding change in patterns of den-

tal treatment. The demand for traditional restorative treatment

(drilling and filling) may fall if preventive care is embraced or may

increase with the average age of the population as people retain

more disease susceptible teeth into older age. There has already

been a change in treatment philosophy. The emphasis in treatment

planning has shifted from the restoration of carious teeth to the

prevention of decay with minimal intervention. The early cari-

ous lesion is reversible (Silverstone 1983), a dynamic equilibrium

between demineralisation and remineralisation especially in the

presence of fluoride (Marinho 2002A; Marinho 2002B; Marinho

2003). Dental caries should be managed by preventive treatment

to encourage the remineralisation of non-cavitated lesions and the

need for restorative treatment can then be delayed or minimised

(Burke 2003).

Much of the research into dental caries diagnosis and manage-

ment has been inadequate. Current clinical diagnosis of caries in

practice is commonly subjective and new diagnostic tools have

not been widely embraced due to a variety of reasons, cost, lack

of familiarity and training, resistance to change, lack of validity,

specificity and reliability (NIHC statement 2001; Bader 2001).

Recent government policy outlined in ’Modernising NHS Den-

tistry - Options for Change’ (Options for Change) introduced a

mandate to promote novel or innovative methods to treat tooth

decay in the UK population. Drilling has always been associated

with some patient trepidation or fearfulness, but failure to inter-

vene may allow further progression towards the pulp and consid-

erable pain. Secondary dental caries can occur when a restoration

(filling) fails and the decay process reoccurs at the margin of a

restoration. Once restorations are in place they eventually fail and

require repetitive replacement, with further drilling away of tooth

material each time, which may eventually lead to total tooth loss.



Ozone is a naturally occurring compound consisting of three oxy-

gen atoms produced by the ultraviolet conversion of oxygen into

the activated, but unstable and short lived form of oxygen. It is a

very powerful oxidising agent and in high concentrations is toxic

to living systems, causing damage to cell membranes (Timbrell

1987). This toxicity has led ozone to be suggested as an agent for

the disinfecting of dental unit water lines (Pankhurst 1998), but

may also be implicated in causing respiratory symptoms in chil-

dren with asthma (Gent 2003).

It has been suggested (PRWeb 2004; Midentistry 2004) that the

application of ozone to carious dental lesions will arrest or reverse

these lesions and that the use of ozone will provide an alternative

to conventional drilling and filling. Theoretically using ozone to

reduce the bacterial count in active carious lesions may temporarily

arrest progression of caries. This may prevent or delay the need

to restore the tooth surface, which would be of benefit to the

public, healthcare providers and to dentists. This review assesses

the effectiveness of ozone application(s) in the management of

caries in vivo.

O B J E C T I V E S

To assess the effectiveness of ozone in arresting or reversing the

progression of dental caries.

The review tested the null hypothesis that there is no difference in

caries progression following the application of ozone or no such

application/placebo.

M E T H O D S

Criteria for considering studies for this review

Types of studies

Randomised controlled trials, with a follow up of at least 6 months

were considered for inclusion. Split-mouth studies were appropri-

ate for inclusion. We originally intended to only include studies

with masked outcome assessment, however it was difficult to as-

certain whether masking occurred or whether it was adequate, so

a post-hoc decision was made not to exclude on this basis.

Types of participants

People, of any age, with caries (including demineralisation in non-

cavitated carious lesions). The caries may have affected any single

tooth surface accessible to the intervention.

Types of interventions

Intervention group: ozone either alone or in combination with

health promotion/oral hygiene plus conventional therapy (when

appropriate).

Control group: no ozone/placebo in combination with health pro-

motion/oral hygiene plus conventional therapy (as in the inter-

vention group).

Types of outcome measures

All outcomes, except for adverse events, were to be assessed at least

6 months from initial treatment.

Primary outcomes

Progression/regression of caries in unrestored cases (assessed clini-

cally or by any other recognised method (Bader 2001) or progres-

sion or regression of secondary caries in restored cases (assessed ra-

diographically against baseline radiograph, pain, failure of restora-

tion assessed clinically or any other method (Bader 2001)).

Secondary outcomes

• Further conventional dental treatment (filling and drilling)

(binary yes/no).

• Time to intervention.

• Pain (assessed by the patient).

• Cost.

• Adverse events.

• Patient satisfaction.

Search methods for identification of studies

The search strategy was developed for MEDLINE on OVID, and

adapted for the other databases. The MEDLINE strategy can be

found in Appendix 1.

The search was run on:

• The Cochrane Oral Health Group’s Trials Register

(November 2003)

• The Cochrane Central Register of Controlled Trials

(CENTRAL) (The Cochrane Library 2003, Issue 3)

• MEDLINE and PREMEDLINE (OVID) (1966 to

November 2003)

• EMBASE (OVID) (1980 to November 2003)

• CINAHL (OVID) (1982 to November 2003)

• AMED (OVID) (1985 to November 2003)

• The internet search engine Google (December 2002).



Handsearching

Quintessence International: preliminary searches suggested that

this journal was a useful source of articles on ozone therapy in

dentistry. Handsearching has been completed by Albert Yeung for

1996 to 2001, the reviewers handsearched 2002.

English and non-English language articles were included and at-

tempts were made to obtain translations of non-English language

articles. Both published and unpublished materials were sought,

unpublished studies and abstracts were only included where they

provided enough methodological detail for them to be appropri-

ately assessed for inclusion.

Experts in the field and manufacturers were contacted in an at-

tempt to find further studies.

Data collection and analysis

Results of all searches were screened by at least two reviewers, inde-

pendently. Full copies of all studies meeting, or potentially meet-

ing, the inclusion criteria were obtained for detailed assessment by

at least two reviewers independently. Where inclusion was unclear

(generally due to randomisation being uncertain) attempts were

made to contact study authors. Where such information was not

obtained, and the original report was in the form of a conference

abstract only, the trial was excluded due to inadequate informa-

tion. Such trials may be included in updates of this review if fur-

ther information becomes available.

Data extraction and validity assessment were conducted inde-

pendently by at least two reviewers. Disagreements were resolved

through discussion by the review team. The authors of included

randomised controlled trials (RCTs) were contacted to ask for

missing information or clarification of data where necessary.

Assessment of validity included the following criteria:

• Randomisation: generation of sequence (yes/no/unclear).

• Allocation concealment (yes/no/unclear).

• Masking of participants/use of placebo (yes/no/unclear).

• Masking of outcome assessors (yes/no/unclear).

• Drop outs accounted for (yes/no/unclear).

• Good measure of interrater reliability reported (yes/no/

unclear).

• Baseline comparability (yes/no/unclear).

• Intention-to-treat analysis used (yes/no/unclear).

It is intended in future updates of this review that the presence

(or otherwise) of commercial sponsorship will be assessed, but this

has not been carried out for this version of the review.

Overall assessment of methodological quality was made on the

following basis: if allocation concealment, masking of outcome

assessors and participants and caries assessment were all adequate,

then the study was considered to be at low risk of bias. If masking

of participants or outcome assessors, or allocation concealment,

was not considered adequate, or was unclear then the study was at

high risk of bias.

Data on all discussed studies were tabulated.

Assessment of heterogeneity

It was planned that a check would be made for clinical heterogene-

ity by examining characteristics in the table of included studies. If

pooling was felt to be reasonable then the random-effects method

would be used, and statistical heterogeneity would be assessed us-

ing Chi2 test (P < 0.1). If heterogeneity existed, this was to be

investigated through subgrouping.

Choice of summary statistic

Binary data were to be presented as risk ratio (RR) with 95%

confidence intervals. Continuous data were presented as weighted

mean differences (WMD).

Combining the trials

Studies with an additional oral hygiene regimen, health promotion

and/or dental health education were to be combined separately

from those using ozone alone.

It was planned that subgroup analyses would be based on the fol-

lowing variables: method of caries assessment; lesion type; baseline

level of caries, plaque or caries risk.

Sensitivity analyses

Sensitivity analyses were to be carried out to assess the sensitivity

of the results to the influence of studies with a high risk of bias.

R E S U L T S

Description of studies

See: Characteristics of included studies; Characteristics of excluded

studies.

Two formally published studies, a large number of conference ab-

stracts, two PhD theses and a submitted manuscript were either

located during the electronic search of databases or the internet,

or provided by Professor E Lynch, a Professor of Restorative Den-

tistry and Gerodontology of the Queen’s University, Belfast, and

were assessed for inclusion. It was unclear from the abstracts how

many potentially relevant randomised trials were in progress, and

clarification of the number of trials was not provided. It may be

that some of these trials will be suitable for inclusion, but this

cannot be assessed until fuller published data become available.

Main reasons for exclusion of the abstracts were: intervention in

extracted teeth rather than people with teeth in situ; randomisa-

tion not stated; less than 6 months data available or supplied; no



relevant outcomes; no further data supplied by the authors within

the time frame of this review.

Three studies were included (Abu-Naba’a 2003; Abu-Naba’a

2003pilot; Baysan 2003) and are described in the table of

Characteristics of included studies.

Abu-Naba’a 2003

Ninety participants with 258 primary occlusal pit and fissure car-

ious lesions were included in this split-mouth study (129 received

ozone, 129 did not but the numbers of ozone and no ozone le-

sions were not necessarily equal in each mouth). Participants were

aged over 12, 88% were under 32 years of age, 39% were male.

They were all attending the Restorative Department of the School

of Dentistry, Queen’s University, Belfast with at least two carious

lesions (accessible to intervention) in their permanent dentition.

Included lesions were assessed and then individually randomised

to either ozone therapy or no ozone groups. Lesions randomised

to receive ozone had 10 seconds of ozone (2100 ppm ozone at

the start of the study, falling to 630 ppm, only 30% of the full

dose, by the end; this reduction in dose was not intended and it

is not clear why it occurred) at baseline, 1, 3, 6 and 9 months.

Lesions randomised to ozone, and to no ozone were sprayed with

a reductant containing fluoride and xylitol at each appointment.

All participants also received a toothbrush, preventive advice and

fluoride containing toothpaste.

Caries progression and regression were measured by change in

clinical severity scores, mean log(e) DIAGNOdent readings and

mean log(e) ECM (electric caries meter) scores at baseline, 1, 3,

6, 9 and 12 months. Patient satisfaction was also assessed.

Abu-Naba’a 2003pilot

Eight participants with 38 primary occlusal pit and fissure carious

lesions were included in the study (19 lesions received ozone, 19

did not). Inclusion criteria were identical to those in Abu-Naba’a

2003.

Included lesions were assessed and then individually randomised

to either ozone therapy or no ozone. Lesions randomised to receive

ozone had 40 seconds of ozone (dose unclear) at baseline, 1, 3 and

6 months. Reductant was sprayed onto ozone and no ozone lesions

(as in the main study). All participants also received a toothbrush,

preventive advice and fluoride toothpaste.

Caries progression and regression were measured by change in

clinical severity scores, mean log(e) DIAGNOdent readings, mean

log(e) ECM scores and other clinical indices (surface destruction,

hardness, visual index, colour of lesion, perceived treatment need,

frostiness of enamel, and enamel undermining) at baseline, 1, 3

and 6 months.

Baysan 2003

Seventy-nine participants with either two or four primary root car-

ious lesions (PRCLs) were randomised to either root sealant or no

root sealant in this split-mouth study. Only the participants ran-

domised to ’no root sealant’ (39 participants) are included in this

review. Lesions of individuals in the ’no root sealant’ group were

randomised to ozone or no ozone, so one lesion received ozone

and one did not, or two received ozone and two did not, within

each individual. Overall, 68 PRCLs received ozone treatment, and

68 PRCLs did not.

The mean age of all 79 participants was 65 years (range 30 to 72),

62% were male (details were not provided separately for partici-

pants not receiving sealant) and all were attending Queen’s Univer-

sity Belfast School of Dentistry. People with advanced periodontal

disease, with active root caries, who were pregnant, had partic-

ipated in another trial within the last 3 months, or had a cross

infection risk were excluded. All included PRCLs were leathery

(severity index two) and accessible to treatment.

Lesions randomised to receive ozone were cleaned with a sterile

toothbrush and water, dried with sterile cotton wool and given

ozone for 10 seconds. After removal of the ozone the cup was filled

with reductant (containing xylitol and fluoride) for 5 seconds.

Treatment was repeated at 3 and 6 months (and a further follow-

up appointment with reductant but no ozone was included at 1

month) and the trial was planned to continue to 1 year. At these

appointments the control lesions also received reductant, and did

not receive ozone (it is unclear whether they were cleaned or dried).

All participants were provided with toothpaste (1100 ppm sodium

fluoride), soft toothbrushes, extensive oral hygiene and preventive

dietary advice.

Caries progression or regression was measured by visual inspection

(per cent of lesions becoming hard) and electrically by an electric

caries monitor (ECM) or DIAGNOdent. Number of fillings were

recorded, and pain, adverse events and satisfaction were assessed

by patient questionnaire.

Risk of bias in included studies

The methodological quality of the three studies is detailed in the

table of Characteristics of included studies.

Given that effective masking of outcome assessors was unclear

(as the outcome assessor was also the operator at the same visit),

masking of participants was absent (as no placebo was provided),

and allocation concealment was unclear, all three trials were judged

to be at high risk of bias.

Effects of interventions

The analyses of all three studies were conducted at the level of the

lesion, which is not independent of the person and is therefore an

inappropriate analysis. A correct analysis would take the clustering

of the lesions within an individual into account (Macfarlane 1999).

For this reason pooling was not appropriate or attempted, and

caution should be exercised interpreting what the studies report as

”significant differences” between teeth treated or not treated with

ozone.

Data were not provided by any study on the number of lesions

requiring restorations performed to 6 months or later.



Data for each outcome measure and each study are presented in

Table 1. No consistent trend indicating a healthcare benefit or

harm following the application of ozone to carious teeth was seen

across the outcome measures from any of the three studies.

Secondary outcomes

No data were provided in any of the included trials on the nature or

occurrence of any further conventional treatment or other dental

interventions, time to intervention, pain or costs.

Adverse events

Baysan 2003 stated that no adverse events were reported to 6

months, no information is provided by Abu-Naba’a 2003 or Abu-

Naba’a 2003pilot.

Patient satisfaction

Abu-Naba’a 2003 reports on participants’ state of anxiety, asking

participants to compare ozone treatment to traditional dental in-

terventions including dental injection, drilling, filling and scaling

and polishing. Participants had lesions randomised to both ozone

and no ozone treatments in their mouths but no injections or

drilling and filling occurred (as far as we are aware). No-one was

randomised between ozone or drilling and filling so that the results

of this questionnaire do not provide valid comparative informa-

tion.

D I S C U S S I O N

Three trials were included with a combined total of 137 partic-

ipants, with 432 lesions. The risk of bias in all studies appeared

high. Changes from baseline of clinical severity index, log(e) Elec-

tric Caries Monitor and log(e) DIAGNOdent scores were pro-

vided at 6 and 12 months (or end measurements at 6 months); no

consistent advantage or disadvantage of ozone on caries was seen

across outcome measures in any study. Few secondary outcomes

were reported, but one trial reported an absence of adverse events.

There is no reliable evidence that the application of ozone gas to

the surface of decayed teeth is effective in arresting or reversing the

progress of dental caries. It is as yet unclear whether there is merit

in this avenue of research and the reviewers would like to encour-

age sound research. Any future trials must be of high quality and

capable of withstanding rigorous independent review.

The difficulties of designing studies to investigate experimental

interventions for the management of dental caries are well docu-

mented (Bader 2001), as are the principles underlying a well de-

signed clinical trial (Petrie 2002A; Petrie 2002B). It is important

that the efficacy of experimental interventions be evaluated under

conditions that are replicable by other researchers, easily general-

isable to primary dental care and where threats to internal validity

are known, they are reported in detail and controlled. The diffi-

culties of caries diagnosis and monitoring (Kidd 1984; Elderton

1985), masking (of participants, operators and assessors), pairing

of lesions, appropriate placebo treatment, allocation concealment,

examiner reliability, interrater reliability, attrition (loss of partic-

ipants from follow up), adequate follow up and sufficient power

to detect clinically important differences in outcomes all need to

be addressed in future studies.

Many of these criteria appear essential for strong and reliable data.

Our included studies did not mask participants, did state that out-

come assessors were masked (but this would appear unlikely as

the same individual operator provided treatment and completed

outcome assessments at the same visit), did use several outcome

measures but only used a single outcome assessor and did not in-

clude power calculations. For these reasons the discussed trials’ re-

sults can be considered highly susceptible to bias. Therefore overall

there was no reliable evidence that ozone treatment was superior

to no treatment for management of pit and fissure or root caries.

The early carious lesion is reversible in vivo and the progress of

active lesions is slow. It may take 6 years for the early enamel le-

sion to progress through enamel to dentine, and up to 53% of pit

and fissure lesions remain unchanged or may reverse in a 21 to

41 month period (Elderton 1985). Any new treatment modalities

designed to arrest or reverse the carious process must be shown to

be effective over the lifetime of the lesion. To be considered signif-

icant any change in caries progression should be demonstrated to

be effective over a 2 to 6 year period. The discussed studies were

therefore much too short to appropriately investigate if the appli-

cation of ozone does or does not arrest the progression of dental

caries.

It is known to be difficult to diagnose the presence of caries, and

to assess the progress of the carious lesion objectively (Elderton

1985; Kidd 1984). The carious lesion occurs in a small highly

mineralised structure and can occur in a variety of different sites

each of which has a unique configuration and rate of spread. These

difficulties make it unlikely that any one diagnostic modality will

have adequate sensitivity and specificity for all sites (Bader 2001).

Where studies are being designed to assess the effectiveness of new

treatment modalities for the management of caries any measures

or techniques used to assess the progress of the lesion must be

demonstrated to be reliable, reproducible, sensitive and specific

due to the dynamic nature of the demineralising and remineralis-

ing process within the carious lesion. In the absence of such mea-

sures any change in caries progression must be validated by several

techniques and several examiners in the context of a controlled

trial not in the wider population. Many of the caries diagnostic

methods mentioned here are not used widely in general dental

practice.



The reviewers have some concerns with regard to the data analyses

of all three studies being conducted at the level of the lesion.

This level is not independent of variables relating to the person

and is therefore an inappropriate analysis which may introduce

inaccuracy and bias. A more appropriate level of analysis would

take the clustering of the lesions within an individual into account

(for more detailed discussion see Macfarlane 1999). For this reason

pooling was not appropriate or attempted, and caution should

be exercised interpreting what the studies report as ’significant

differences’ between teeth treated or not treated with ozone which

may be in fact in a small number of individuals.

It has been suggested that the application of ozone to carious den-

tal lesions will reverse these lesions and provide an alternative to

conventional drilling and filling. Ozone may disrupt the dental

bacterial plaque and arrest progression of the lesion however ozone

per se will not reverse the lesion, rather it may produce an envi-

ronment in which arrest of the carious lesion could occur.

In the presence of early carious lesions with no cavitation it has long

been understood that current preventative dental treatments can

be used to reverse or halt the demineralisation process, shifting the

ionic exchange at the tooth surface in favour of remineralisation.

Simple measures involving disruption of the dental plaque, which

have been shown to be effective, include: professional prophylaxis;

restriction of the bacterial substrate by modification of the diet

(DHHS 1999); the use of sugar free chewing gum (Machiulskiene

1999); and use of fluoride toothpaste (Marinho 2003). The use

of self applied fluoride supplements has been shown to be effec-

tive at reducing caries in high risk children who are compliant

(Riordan 1999), as have self applied fluoride rinses in high risk

children, adolescents, adults and the elderly (Davies 2003). The

application of professionally applied fluoride varnishes and gels

has been shown beneficial in high risk children, adolescents and

adults (Davies 2003; Marinho 2002A; Marinho 2002B). There-

fore, on the basis of the research currently available, the applica-

tion of ozone conveys no additional benefit to the preventative

treatments outlined above. Additionally where cavitation has al-

ready occurred conventional treatment will be still be required to

facilitate effect plaque removal .

The reviewers found significant failings in reporting in this review’s

three studies. Firstly no quantification of ozone output from the

HealOzone unit was reported (and appears in one of the included

studies to have failed). Secondly only passing mention was made

of the content of the ’reductant’, a solution applied after ozone

treatment to the carious tooth surface by the single operator in

both the treatment and control groups (in many of the studies).

On clarification from the manufacturers, KaVo, reductant was

identified as a 2% solution of sodium fluoride and 5% xylitol.

Given the evidence above the reporting of the use of the reductant

lacked detail particularly in the control groups. The reviewers felt

it would be far more enlightening to compare the use of ozone/

placebo in masked groups with/without fluoride reductant in a

well designed and conducted trial minimising bias to elucidate the

efficacy of ozone gas application as a treatment for dental caries.

Additionally the interaction between ozone and topical fluoride is

unknown and needs to be investigated. It was felt a very detailed

level of reporting would be helpful to determine the role of the

reductant solution, pre or post treatment oral hygiene instruction

and the use and application of fluoride containing dentifrice at

home on the outcomes measured.

The application of topical fluoride is cheap, simple and effective.

The clinical effectiveness, cost effectiveness and ease of application

of ozone need to be elucidated and may by comparison be much

more expensive. Abu Naba’a (Abu-Naba’a 2003) suggests that the

application of ozone is most effective following three applications

in 3 months, that with less frequent application it becomes less

effective and that poor compliance in terms of attendance reduces

effectiveness. If this is shown to be the case, the acceptability to

patients of such frequent attendance, and the cost implications,

need to be investigated. A recent paper (Holmes 2003E) suggested

that a single tooth ozone treatment should be costed at £68 in

the UK (equivalent to 122 US dollars or 101 Euros), and a full

mouth ozone treatment at UK £245 (equivalent to US$438 or

365 Euros). This will put this treatment modality out of reach of

a substantial percentage of the population at risk including those

in high risk groups, such as the socially deprived.

The clinical effectiveness and cost effectiveness of ozone applica-

tion is unknown. It is not known what the optimal concentration

of ozone might be, how long it should be applied for, how long

any effects might last, how deep into the lesion it might penetrate,

or whether ozone has any other effects. Further research is needed

to answer these questions, but it must be of adequate quality to

provide good evidence. Presently there is no good evidence that

the application of ozone gas to the surface of decayed teeth is effec-

tive in arresting or reversing the progression of dental caries, and

ozone should not be considered an alternative to current methods

for the management and treatment of dental caries.

The reviewers felt it would have been more appropriate to compare

anxiety levels with preventive dental procedures such as topical flu-

oride application, fissure sealing or placement of preventive resin

restorations within a study. The comparison with more invasive

restorative procedures such as injection and drilling is irrelevant.

In summary

Overall this systematic review of all relevant randomised controlled

trials found no good evidence that ozone treatment was superior

to no treatment for management of pit and fissure or root caries.

Across the results of the three trials included in this review there

is no consistent pattern of efficacy of ozone. There is no good ev-

idence that the application of ozone gas to the surface of decayed

teeth is effective in arresting or reversing the progression of dental



caries. The available studies investigating the effectiveness of ozone

in management of dental decay appear to be at high risk of bias.

There is no evidence to disprove the null hypothesis that there

is no difference in caries progression following the application of

ozone. There is a fundamental need for more evidence of appro-

priate rigour and quality before the use of ozone can be accepted

into mainstream primary dental care or can be considered a viable

alternative to current methods for the management and treatment

of dental caries.

A U T H O R S ’ C O N C L U S I O N S

Implications for practice• There is no good evidence that ozone application is

effective in arresting or reversing the progression of dental caries.

• There is no good evidence to support the use of ozone in a

primary care setting.

• Evidence of appropriate rigour and quality must become

available before ozone can be widely accepted. Ozone therapy

should not gain acceptance nor be used in general practice unless

valid evidence of its clinical effectiveness and (ideally) cost

effectiveness becomes available.

• Dental care providers or users of dental services should not

advocate the use of ozone gas on the sole basis of high patient

acceptability or desirability as compared to less attractive

conventional dental injection local anaesthesia, filling and

drilling.

• This group of reviewers wish to encourage an evidence-

based approach to the management of dental caries particularly

in the primary care setting of general dental practice despite the

barriers to its use such as lack of available clinical time and

financial constraints (Iqbal 2002).

Implications for research

There are currently no peer reviewed trials or papers published in

journals of repute on the efficacy of the use of ozone in dentistry.

There appear to be several longitudinal RCTs in progress but their

quality is unknown at the time of this review. A substantive update

of this review will be carried out when a body of published peer

reviewed data becomes available.

There is a need for well-conducted, valid studies to assess the

effectiveness of ozone in the management of dental caries. The

following issues will need to be addressed in future trials of ozone

for caries management:

• New treatments designed to arrest or reverse the carious

process must ideally be shown to be effective over the lifetime of

the lesion. To be considered significant any change in caries

progression should be demonstrated to be effective over at least a

2 to 6 year period.

• The development and use of a standard set of valid criteria

for the diagnosis and the assessment of progression of early

carious lesions would be desirable. Where studies are being

designed to assess the effectiveness of new treatments for the

management of caries any measures or techniques used to assess

the progress of the lesion must be demonstrated to be reliable,

reproducible, sensitive and specific. In the absence of such

measures any change in caries progression must be validated by

several techniques and several examiners (Bader 2001; Cohen

1968; Streiner 1990).

• Use of sample size calculations, to ensure that studies are

adequately powered to show clinically relevant effects if they

exist, should be encouraged.

• Allocation concealment should be adequate (Schulz 1995).

• Lesions should be randomised so that equal numbers of

intervention and placebo lesions exist in each mouth, and

analyses should provide outcome data per person rather than per

tooth (Macfarlane 1999).

• Robust masking of participants (using an appropriate

placebo treatment), operators and outcome assessors is essential

(Everitt 1995; Fyffe 2000).

• Assessment of examiner reliability and interrater reliability,

with the use of several masked assessors, is necessary in high

quality trials (Tranaeus 2002).

• Better reporting of adverse events, for example asthma

incidents, is required.

• The availability of new funding in the primary care setting

may in future need to be linked to quality assurance in research

design.

A C K N O W L E D G E M E N T S

This review came about as a direct result of a small number of

general dental practitioners and members of the Dental Defence

Agency enrolling on the inaugural Evidence Base for Effective

Clinical Practice Module of the recently developed pathway to the

Fellowship of the Faculty of General Dental Practitioners (UK)

by assessment. Thank you to the Faculty, in particular Malcolm

Pendlebury and 3M/ESPE for their support, vision and develop-

ment of this initiative in continuing professional development and

lifelong learning for general dental practitioners. Our thanks go to

the conveners of the course, Dr Jan Clarkson for her skills of per-

suasion and leadership, Professor Helen Worthington for her en-

lightenment on statistics, and Anne-Marie Glenny for her course



contribution and literature searching skills. We would also like to

thank course-member Anita Davies who first posed the question

about the effectiveness of ozone and the following researchers who

replied to our requests for additional information about their tri-

als: Professor E Lynch, Dr Layla Abu-Naba’a, Dr Aylin Baysan and

Mr P Stinson. Thanks also for the handsearching skills of Albert

Yeung.

R E F E R E N C E S

References to studies included in this review

Abu-Naba’a 2003 {published and unpublished data}

Abu-Naba’a L. Management of Primary Occlusal Pit and

Fissure Caries Using Ozone. Report by RKS Consultancy,

PO Box 81, 1250 AB Laren NH, The Netherlands 32.

Abu-Naba’a L, Al Shorman H, Lynch E. Ozone management

of occlusal pit and fissure caries (PFC): 12-month review

[abstract]. Provided by Prof E Lynch, source unclear

undated. [: Abst]

Abu-Naba’a L, Al Shorman H, Lynch E. Ozone Treatment

of Primary Occlusal Pit and Fissure Caries: 12-month ECM

Results and Clinical Implications [abstract]. Presented at

the 50th Annual Congress of European Organization for

Caries Research. Konstanz, Germany, 2–6 July 2003. [:

AbstORCAkonstanz2]

Abu-Naba’a L, Al Shorman H, Stevenson M, Lynch E.

Ozone Treatment of Pit and Fissure Caries: 6-month

Results [abstract]. Presented at the AADR meeting. San

Antonio, USA, March 2003.∗ Abu-Naba’a LA. Management of primary occlusal pit and

fissure caries using ozone [PhD Thesis]. Belfast, UK: Faculty

of Medicine and Health Sciences, Queen’s University, 2003.

Abu-Naba’a 2003pilot {published data only}

Abu-Naba’a LA. Management of primary occlusal pit and

fissure caries using ozone [PhD Thesis]. Belfast, UK: Faculty

of Medicine and Health Sciences, Queen’s University, 2003.

Baysan 2003 {published and unpublished data}

Baysan A. Management of primary root caries using ozone

therapies [PhD Thesis]. London: Department of Adult Oral

Health, Bart’s and The London Queen Mary’s School of

Medicine and Dentistry, 2003.

Baysan A, Lynch E. Clinical reversal of root caries using

ozone [abstract]. AADR Conference Abstracts 2002:

http://iadr.confex.com/iadr/2002SanDiego/techprogram/

(accessed Feb 2002).∗ Baysan A, Lynch E. Management of root caries using

ozone. American Journal of Dentistry [submitted]. [:

electronic ABO3CariesRes]

References to studies excluded from this review

Abu-Naba’a 2001 {published data only}

Abu-Naba’a L, Lynch E, Jonavonski V, Zou L, Cunnigham

L. Fissure Sealant Quantification by 3-D C0-Ordinate

Analysis [abstract]. Presentation at the 48th Annual

Scientific Meeting of the Irish and British divisions of

IADR. 9–12 April 2001.

Abu-Naba’a 2002A {published data only}

Abu-Naba’a L, Al Shorman H, Lynch E. In-vivo treatment

of occlusal caries with ozone: immediate effect and

correlation of diagnostic methods [abstract]. Presented at

the 49th Annual Congress of the European Organization

for Caries Research. Naantali, Finland, 3–6 July 2002.

Abu-Naba’a 2002B {published data only}

Abu-Naba’a L, Al Shorman H, Lynch E. Efficacy of ozone in

the treatment of pit and fissure caries [abstract]. Presented at

the 19th Annual Scientific Meeting. IADR, Irish Division.

Cork, Ireland, 25–26 January 2002.

Abu-Naba’a 2002C {published data only}

Abu-Naba’a L, Al Shorman H, Lynch E. Ozone efficacy in

the treatment of pit and fissure caries [abstract]. The First

Pan European Festival of Oral Sciences. Cardiff, UK, 2002.

Abu-Naba’a 2002D {published data only}

Abu-Naba’a L, Al Shorman H, Lynch E. The effect of

ozone application on fissure caries QLF readings [abstract].

AADR Conference Abstracts. San Diego: AADR, 2002:

http://iadr.confex.com/iadr/2002SanDiego/techprogram/

abstract_20059 (accessed March 2003).

Abu-Naba’a 2003A {published data only}

Abu-Naba’a L, Al Shorman H, Lynch E. Clinical indices

changes in ozone treatment of pit and fissure caries

[abstract]. AADR Conference Abstracts. 2003:http:

//iadr.confex.com/iadr/2003SanAnton/techprogram/

abstract_27273.htm (accessed February 2003). [: 1173]

Abu-Naba’a 2003B {published data only}

Abu-Naba’a L, Al Shorman H, Lynch E. 6-month Clinical

Indices Changes after Ozone Treatment of Pit and Fissure

Caries (PFC) [abstract]. Presented at the Annual Scientific

Meeting of IADR. Goteborg, Sweden, June 2003.

Abu-Salem undated {published data only}

Abu-Salem OT, Marashdeh MM, Lynch E. Ozone Efficacy

in Treatment of Occlusal Caries in Primary Teeth [abstract].

Oral Health Care research Center, Queen Elisabeth

University, Belfast, Northern Ireland. undated, source

unclear, provided by Prof. E Lynch.

Al Shorman 2002 {published data only}

Al Shorman H, Abu-Naba’a L, Lynch E. Patients’ Attitude to

Treatment of Pit and Fissure Caries with Ozone [abstract].



Presented at the 49th Annual Congress of European

Organization for Caries Research. Naantali, Finland, 3–6

July 2002.

Al Shorman undated {published data only}

Al Shorman H, Abu-Naba’a L, Coulter WA, Lynch E.

Primary Colonization of DUWL by P. aeruginosa and

its Eradication by Ozone [abstract]. Provided by Prof E

Lynch, Queen’s University Belfast, United Kindom, source

unknown Undated.

Baysan 2000 {published data only}

Baysan A, Whiley RA, Lynch E. Antimicrobial effect

of a novel ozone-generating device on micro-organisms

associated with primary root carious lesions in vitro. Caries

Research 2000;34(6):498–501.

Baysan 2001 {published data only}

Baysan A, Lynch E. Management of primary root carious

lesions using ozone in vivo. Journal of Dental Research.

2001; Vol. 80, issue AADR Abstract:37.

Baysan 2003A {published data only}

Baysan A, Lynch E. Effect of ozone on the oral microbiota

and clinical severity of primary root caries. American

Journal of Dentistry 2003 [in press].

Cardon 2002 {published data only}

Cardon BE, Eleazer PD, Miller RD, Staat RH. Low

concentration ozone treatment insufficient to control

DUWL biofilm [abstract]. AADR Conference Abstracts.

2002:http://iadr.confex.com/iadr/2002SanDiego/

techprogram/ (accessed Feb 2003).

Chang undated {published data only}

Chang HH, Fulton C, Lynch E. Antimcirobial efficacy of

ozone on enterococcus faecalis [abstract]. Provided by Prof

E Lynch, source unknown Undated. [: 36760]

Claxson 2002 {published data only}

Claxson A, Smith C, Turner M, Silwood C, Lynch

E, Grootveld M. Oxidative Modification of Salivary

Biomolecules with Therapeutic Levels of Ozone [abstract].

AADR Conference Abstracts. 2002:http://iadr.confex.com/

iadr/2002SanDiego/techprogram/ (accessed Feb 2003).

Clifford undated {published data only}

Clifford C. Successful use of Airbrasion in Conjunction

with Ozone Treatment [abstract]. Provided by Prof E

Lynch, source unknown Undated.

Daly 2003 {published data only}

Daly T, Lynch E. Reversal of Occlusal Pit and Fissure Caries

by Ozone [abstract]. AADR Conference Abstracts. 2003:

http://iadr.confex.com/iadr/2003SanAnton/techprogram/

abstract_27531.htm (accessed Feb 2003).

Daly undated {published data only}

Daley T, Lynch E. Reversal of Occlusal Pit and Fissure

Caries by Ozone. Private Practice, Harwich. United

Kindom. Undated, source unknown, provided by Prof E

Lynch.

Domingo 2002 {published data only}

Domingo H, Abu-Naba’a L, Al Shoreham H, Holmes J,

Marashdeh MM, Abu-Salem OT, et al.Reducing barriers

to care in patients managed with ozone [abstract]. IADR

Electronic Abstract Submission Form. Cardiff: IADR,

2002.

Domingo 2003 {published data only}

Domingo H, Abu-Naba’a L, Al Shorman H, Holmes

J, Marashdeh M, Abu-Salem O. Reducing Barriers to

Care in Patients Managed with Ozone [abstract]. AADR

Conference Abstracts. 2003:http://iadr.confex.com/iadr/

2003SanAnton/techprogram/abstract_27392.htm (accessed

Feb 2003).

Holmes 2003A {published data only}

Holmes J, Lynch E. Arresting Occlusal Fissure Caries using

Ozone [abstract]. AADR Conference Abstracts. 2003:


abstract_27455.htm (accessed Feb 2003). [: 0678]

Holmes 2003B {published data only}

Holmes J, Grootveld M, Smith C, Claxson A, Lynch

E. Bleaching of Components Responsible for Extrinsic

Tooth Discoloration by Ozone [abstract]. AADR


2003SanAnton/techprogram/abstract_27410 (accessed

February 2003).

Holmes undated {published data only}

Holmes J. Clinical Reversal of Primary Occlusal Fissure

Carious Lesions (POFCLs) Using Ozone in General Dental

Practice. Web site: http://www.the-o-zone.cc/research/

fsd02.doc (undated) (accessed October 2003).

Jackson 2003 {published data only}

Jackson P, Lynch E. Healing of Pit and Fissure Caries after

Using Ozone [abstract]. AADR Conference Abstracts.

2003:http://iadr.confex.com/iadr/2003SanAnton/

techprogram/abstract_28324.htm (accessed Feb 2003). [:

1174]

Johnson 2003A {published data only}

Johnson N, Johnson J, Johnson K, Abu-Naba’a L, Al

Shorman H, Freeman R, et al.Patients’ Attitudes to Dental

Treatment using Ozone vs. Conventional Treatment




Johnson 2003B {published data only}

Johnson N, Johnson J, Lynch E. Cost Benefit Assessment

of a Novel Ozone Delivery System vs. Conventional

Treatment [abstract]. AADR Conference Abstracts. 2003:



Johnson 2003C {published data only}

Johnson N, Johnson J, Johnson K, Lynch E. Effective

Treatment of Occlusal Fissure Caries Using Ozone



abstract_27377.htm (accessed Feb 2003). [: 0676]

Johnson 2003D {published data only}

Johnson N, Johnson J, Domingo H, Lynch E. Comparison

of Conventional Treatment vs Ozone for Occusal Caries

with Ozone Therapy [abstract]. Proceedings of the Annual



Scientific Meeting of IADR. Goteborg, Sweden: http://

iadr.confex.com/iadr/2003Goteborg/techprogram/abstract_

36903.htm, 25–28 June 2003.

Lynch 2003 {published data only}

Lynch E, Johnson N, Johnson J, Johnson K. Effective

Treatment of Occlusal Fissure Caries Using Ozone

[abstract]. Proceedings of the Annual Scientific Meeting of

IADR. Goteborg, Sweden, 25–28 June 2003. [: 36975]

Lynch undated {published data only}

Lynch E, Baysan A, Silwood CJ, Mills B, Grootveld M.

Oxidation of root caries biomolecules by an anti-bacterial

ozone-generating device [abstract]. Source unclear, provided

by Prof E Lynch, December 2002.

Marashdeh 2003 {published data only}

Marashdeh M, Abu-Salem O, Lynch E. Ozone Treatment

of Occlusal Caries in Primary Teeth: Immediate Effects

and Correlation of Diagnostic Methods [abstract]. AADR



Feb 2003). [: 0683]

Megighian 2003A {published data only}

Megighian GD, Bertolini L. Invivo Treatment of Occlusal

Caries with Ozone: One and Two Months’ Effect with

Light-induced Fluorescence (QLF) as Diagnostic Methods

[abstract]. Proceedings of the Annual Scientific Meeting of

IADR. Goteborg, Sweden, 25–28 June 2003. [: Abstract

ID 36918]

Megighian 2003B {published data only}

Megighian GD, Dal Vera MV. Patients’ Attitudes toward

and Satisfaction with Managing Caries with Ozone as a

Routine Treatment in Dental Private Practice [abstract].

Proceedings of the Annual Scientific Meeting of IADR.

Goteborg, Sweden, 25–28 June 2003. [: 36937]

Morrison 2003A {published data only}

Morrison R, Lynch E. Remineralization of Occlusal Pit

and Fissure Caries After Using Ozone [abstract]. AADR



February 2003). [: 0680]

Morrison 2003B {published data only}

Morrison R. Clinical reversal of occlusal pit and fissure

caries after using ozone [abstract]. Proceedings of the

Annual Scientific Meeting of IADR. Goteborg, Sweden,

25–28 June 2003.

Reaney 2003 {published data only}

Reaney D, Lynch E. Clinical Reversal of Pit and Fissure

Caries After Using Ozone [abstract]. AADR Conference

Abstracts 2003:http://iadr.confex.com/iadr/2003SanAnton/

techprogram/abstract_27352.htm (accessed Feb 2003).

Reaney undated {published data only}

Reaney D, Lynch E. Clinical Reversal of Pit and Fissure

Caries After Using Ozone. PowerPoint slide GKT, King’s

College Dental Institute, London, England undated.

Sandhaus 1965 {published data only}

Sandhaus S. Ozone therapy in odontstomatology, especially

in treatments of infected root canals [L’Ozonetherapie en

odontostomatologie particulierement dans les traitments

des canaux radiculaires infectes]. Revue Belge de Medecine

Dentaire 1965;20(6):633–46.

Stinson 2003A {published data only}

Stinson P, Al Shorman H, Abu-Naba’a L, Lynch E. Clinical

Reversal of Occlusal Pit and Fissure Caries After Using

Ozone [abstract]. AADR Conference Abstracts. 2003:



Stinson 2003B {published data only}

Stinson P. Clinical Reversal of Occlusal Pit and Fissure

Caries After Using Ozone [abstract]. Proceedings of the

Annual Scientific meeting of IADR. Goteborg, Sweden,

25– 28 June 2003.

Stinson undated {published data only}

Stinson P, Al Shorman H, Abu-Naba’a L, Lynch E. Clinical

Reversal of Occlusal Pit and Fissure Caries after Using

Ozone. PowerPoint slide, submitted by Prof E Lynch.

Queen’s University, Belfast, UK undated.

References to studies awaiting assessment

Abu-Salem 2003 {published data only}

Abu-Salem O, Lynch E. Ozone Efficacy in Treatment of

Occlusal Caries in Primary Teeth [abstract]. 81st General

Session of the International Association for Dental Research.

Goteborg, Sweden, 2003.

Abu-Salem O, Marashdeh M, Lynch E. Ozone efficacy in

treatment of occlusal caries in primary teeth [abstract].

AADR Conference Abstracts. 2003:http://iadr.confex.com/

iadr/2003SanAnton/techprogram/abstract_27686.htm

(accessed Feb 2003).

Al Shorman 2003 {published data only}

Al Shorman H, Abu-Naba’a L, Coulter WA, Lynch E.

Primary colonization of DUWL by P.aeruginosa and its

eradication by ozone [abstract]. 81st General Session of the

International Association of Dental Research. Goteborg,

Sweden, 2003.

Chang 2003 {published data only}

Chang HH, Fulton C, Lynch E. Antimicrobial efficacy of

ozone on enterococcus faecalis [abstract]. 81st General

Session of the International Association of Dental Research.

Goteborg, Sweden, 2003.

Clifford 2003 {published data only}

Clifford C. Successful use of airbrasion in conjunction with

ozone treatment [abstract]. 81st General Session of the


Sweden, 2003.

Cronshaw 2003 {published data only}

Cronshaw MA. Treatment of primary occlusal pit and

fissure caries with ozone: six month results [abstract]. 81st

General Session of the International Association of Dental

Research. Goteborg, Sweden, 2003.



Hamid 2004 {published data only}

Hamid A. Clinical reversal of occlusal pit and fissure caries

using ozone. 82nd General Session of IADR/AADR/

CADR. Hawaii, 2004.

Holmes 2003C {published data only}

Holmes J. Clinical reversal of occlusal pit and fissure

caries using ozone [abstract]. 81st General Session of the


Sweden, 2003. [: 36308]

Holmes 2003E {published data only}

Holmes J. Clinical reversal of root caries using ozone,

double-blind, randomised, controlled 18-month trial.

Gerodontology 2003;20(2):106–14.

Lynch 2003b {published data only}

Lynch E, Silwood C, Smith C, Grootveld M. Oxidising

actions of an anti-bacterial ozone-generating device towards

root caries biomolecules [abstract]. 81st General Session of

the International Association of Dental Research. Goteborg,

Sweden, 2003.

Morrison 2003C {published data only}

Morrisson R, Lynch E. Efficacy of ozone to reverse occlusal

caries [abstract]. 81st General Session of the International

Association of Dental Research. Goteborg, Sweden, 2003.

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World Health Organisation: Geneva 1990.∗ Indicates the major publication for the study



C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Abu-Naba’a 2003

Methods Study type: RCT, lesions individually randomised to either ozone therapy or no ozone groups according to

computer generated random sampling digit tables (exact method unclear). Teeth were allocated to ’ozone’

and to ’no ozone’ in every mouth, though not always in equal numbers. In some participants teeth were

also allocated to ’ozone plus sealant’ or ’no ozone plus sealant’ (results in these teeth are not reported in

this systematic review).

Allocation concealment: stated as concealed but appears to use an open random number table.

Masking of patient and/or parent: not done, no placebo ozone treatment was given.

Masking of outcome assessors: unclear. While the authors state that outcome assessment was masked it is

unclear how effective this was, given that the assessor was also the operator at the same visit.

Interrater reliability: not done, single operator/ assessor.

Groups comparable at baseline: no, differences exist in clinical severity scores at baseline (50% scored 1

in the ozone group, 62% in the no ozone group).

Drop outs: 58 of 90 participants attended all visits, one subject missed all visits after the initial visit (and

was excluded from the study). 25 participants missed one visit, four missed two and two missed three

visits.

ITT: no (those without readings at a visit were excluded from analysis).

Other treatments equivalent: yes.

Participants Inclusion criteria: attending School of Dentistry, Queen’s University, Belfast. Male or female aged over

12 years, with at least two primary pit or fissure lesions (without cavitation) in permanent posterior teeth

accessible to diagnostic procedures (ECM and DIAGNOdent). Clinical severity scores were 1 to 3 and

DIAGNOdent readings = 10. Participants were considered reliable attenders and available for the duration

of the study.

Exclusion criteria: where participants had an odd number of lesions suitable for inclusion the lesion with

the lowest DIAGNOdent reading was excluded from randomisation. Participants were excluded for the

presence of advanced periodontal disease, participation in another study in past month or any condition

that in the opinion of the investigator would preclude participation by the subject (e.g. cross infection

risk).

Randomised: 90 participants, 258 lesions (129 in the ozone group, 129 in the no ozone group), 61%

female.

Mean age: not stated. Most were teenagers and young adults. Five subjects were aged 12 to 15, 74 were

aged 15 to 31, 11 were older than 31 years.

Baseline level of caries: clinical severity averaged 1.6 in the ozone treated lesions, 1.4 in the no ozone

lesions. ECM scores averaged 11.6 in the ozone treated lesions, 15.2 in the no ozone lesions. Participants

had 2 to 14 included lesions, often with numerous filled teeth and some decayed beyond the inclusion

criteria.

Caries risk assessment: not stated.

Interventions Intervention lesions: at 0, 1, 3, 6 and 9 months the lesions were disclosed, cleaned with an air abrasion

system (PROPHYflex), outcomes assessed, ozone applied for 10 seconds, then reductant sprayed on. At

the 12 month final visit no ozone was applied.

Control lesions: at 0, 1, 3, 6, 9 and 12 months the lesions were disclosed, cleaned with an air abrasion

system (PROPHYflex), outcomes assessed, then reductant sprayed on.

All participants: extensive oral hygiene and dietary advice was provided, a toothbrush and toothpaste (1,



Abu-Naba’a 2003 (Continued)

100 ppm fluoride) were provided at each appointment.

Operator: single operator/assessor (Layla Abu-Naba’a).

Outcomes Caries progression or regression measured by clinical severity index, ECM, and DIAGNOdent. Anxiety

assessed

Notes Reductant (containing xylitol at = 5% by weight and fluoride at 1100 ppm, as well as other compounds)

was used for each lesion at each visit (0, 1, 3, 6 and 9 months).

This study also randomised lesions in some participants to receive the interventions above plus a sealant,

these lesions have been excluded from the current analysis.

The authors stated in correspondence that blinded outcome assessment occurred, however a single operator

was responsible for both outcome assessment and ozone delivery to appropriate lesions at 0, 1, 3, 6 and

9 months.

The actual level of ozone delivered was correct at the start of this study, but very much lower than expected

at the end. It is unclear how many full strength doses were actually delivered

Risk of bias

Item Authors’ judgement Description

Allocation concealment? Unclear B - Unclear

Abu-Naba’a 2003pilot

Methods Study type: RCT, lesions individually randomised to either ozone therapy or no ozone groups according to

computer generated random sampling digit tables (exact method unclear). Teeth were allocated to ’ozone’

and to ’no ozone’ in every mouth, though not always in equal numbers.

Allocation concealment: unclear.

Masking of patient and/or parent: not done, no placebo ozone treatment was given.



Interrater reliability: not done, single operator/assessor.

Groups comparable at baseline: no, differences exist in clinical severity scores at baseline (21% scored 1,

42% scored 2 in the ozone group, 21% scored 1 and 58% scored 2 in the no ozone group).

Drop outs: 13 of 19 lesions randomised to ’ozone’ and 12 of the 19 lesions randomised to ’no ozone’

attended the 6 month follow up.

ITT: no (those without readings at a visit were excluded from analysis).

Other treatments equivalent: yes.

Participants Inclusion criteria: attending School of Dentistry, Queen’s University, Belfast. Male or female aged over 12

years, with at least two primary pit or fissure caries (including cavitated lesions) in permanent posterior

teeth accessible to diagnostic procedures (ECM and DIAGNOdent). Clinical severity scores were 1 to

3 and DIAGNOdent readings = 10. Participants were considered reliable attenders and available for the

duration of the study.

Exclusion criteria: where participants had an odd number of lesions suitable for inclusion the lesion with

the lowest DIAGNOdent reading was excluded from randomisation. Participants were excluded for the

presence of advanced periodontal disease, participation in another study in past month or any condition

that in the opinion of the investigator would preclude participation by the subject (e.g. cross infection



Abu-Naba’a 2003pilot (Continued)

risk).

Randomised: 8 participants, 38 lesions (19 in the ozone group, 19 in the no ozone group).

Mean age: not stated.

Baseline level of caries: (See under comparability at baseline).


Interventions Intervention lesions: at 0, 1, 3 and 6 months the lesions were cleaned, outcomes assessed, ozone applied

for 40 seconds, then reductant sprayed on.

Control lesions: at 0, 1, 3, and 6 months the lesions were cleaned, outcomes assessed, then reductant

sprayed on.

All participants: preventive advice was provided, as were a toothbrush and toothpaste (1100 ppm fluoride)

.

Operator: single operator/assessor (Layla Abu-Naba’a).

Outcomes Caries progression or regression measured by clinical severity index, ECM, DIAGNOdent and other

clinical indices (surface destruction, hardness, visual index, colour of lesion, perceived treatment need,

frostiness of enamel, enamel undermining). Anxiety assessed, but not as part of the randomised trial


was used for each lesion at each visit.

The authors stated in correspondence that blinded outcome assessment occurred, however a single operator

was responsible for both outcome assessment and ozone delivery to appropriate lesions at 0, 1, 3 and 6

months.

The actual level of ozone delivered was unclear (see notes under main study)

Risk of bias





Baysan 2003

Methods Study type: RCT, sequence generated by statistitian at Queen’s University, 2 or 4 primary root carious

lesions randomised, with equal numbers to intervention and control, in each mouth.

Allocation concealment: stated as concealed by author (however sequence presented in thesis as an open

list).

Masking of patient and/or parent: not done.



Interrater reliability: not done (single operator).

Groups comparable at baseline: unclear.

Drop outs: 4 people dropped out by 3 months, unclear how many lesions this represents, or number of

drop outs at 6 months.

ITT analysis: unclear.

Other treatment equivalent: unclear. The submitted paper suggests that the teeth receiving ozone were

cleaned before ozone and the reductant were applied, but the teeth not receiving ozone were not cleaned

before the reductant was applied. However, the PhD implies that in control group the teeth were cleaned

before caries measurements were taken, and so were cleaned before the reductant was applied

Participants Inclusion criteria: male and female at least 18 years old, with leathery root carious lesions (severity index 2)

on at least two surfaces and accessible for diagnostic procedure (electronic caries meter and Diagnodent).

Exclusion criteria: participants with advanced periodontal disease, who had participated in another dental

study in past 3 months, were pregnant or had any condition precluding participation (e.g. cross infection

risk).

Randomised: 39 participants, 68 teeth in intervention, 68 in control group, each participant had equal

numbers of intervention and control lesions (2 or 4 in total).

Mean age: unclear.

Baseline level of caries: not stated.


Interventions Intervention lesions: at initial visit tooth surface cleaned with sterile toothbrush and water, dried, ozone

applied for 10 seconds into cup, suction applied for 10 seconds, reductant applied for 5 seconds. Repeated

at 1 month (with no ozone), 3 months and 6 months (both with ozone for 10 seconds).

Control lesions: at initial visit no ozone (or placebo) applied, and no cleaning occurred, but reductant

applied for 5 seconds. Repeated at 1, 3 and 6 months.

All participants: standard dentifrice (1100 ppm sodium fluoride) and soft toothbrushes were provided to

all participants during the study.

Duration of follow up: 12 months stated intent, but results found for 6 months maximum.

Operator: Aylin Baysan, single operator.

Outcomes Caries progression or regression (’% lesions becoming hard’, Electric Caries Meter and DIAGNOdent

readings). It was stated that further dental interventions, pain, patient satisfaction and adverse events were

recorded, but these have not been reported at 6 months or later


was used at each visit (0, 1, 3 and 6 months).

Protocol states that if participants present with discomfort the primary root carious lesions would be

immediately treated by drilling and filling.

The same study also randomised participants to receive the interventions above plus a sealant, these

participants have been excluded from the current analysis.

Study included as authors stated in correspondence that blinded outcome assessment occurred, however



Baysan 2003 (Continued)

a single operator was responsible for outcome assessment and ozone delivery to appropriate lesions at 0,

3 and 6 months

Risk of bias



Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Abu-Naba’a 2001 In vitro study.

Abu-Naba’a 2002A Less than 6 months follow up.

Abu-Naba’a 2002B Less than 6 months follow up.

Abu-Naba’a 2002C Less than 6 months follow up.

Abu-Naba’a 2002D In vitro study.

Abu-Naba’a 2003A Not a randomised controlled trial.

Abu-Naba’a 2003B Not a randomised controlled trial.

Abu-Salem undated Less than 6 months follow up.

Al Shorman 2002 Primary outcome not assessed.

Al Shorman undated No relevant outcome measured (study in water lines, not teeth)

Baysan 2000 In vitro study.

Baysan 2001 No control group (all lesions given ozone).

Baysan 2003A No control group (all lesions given ozone), less than 6 months follow up

Cardon 2002 Not assessing effect of ozone on caries (in dental unit water lines)

Chang undated No teeth or caries involved, in vitro.

Claxson 2002 In vitro study.



(Continued)

Clifford undated No assessment of the effect of ozone on caries, no control group

Daly 2003 Less than 6 months follow up.

Daly undated Less than 6 months follow up.

Domingo 2002 Not 6 months follow up (immediate effects only).

Domingo 2003 Not a randomised controlled trial.

Holmes 2003A Follow up less than 6 months.

Holmes 2003B Did not assess the effect of ozone on caries (nor on teeth).

Holmes undated No control group, follow up less than 6 months.

Jackson 2003 Less than 6 months follow up.

Johnson 2003A Not a randomised controlled trial.

Johnson 2003B Cost benefit study, less than 6 months follow up.

Johnson 2003C Less than 6 months follow up.

Johnson 2003D Time expenditure study, not a controlled trial.

Lynch 2003 Less than 6 months follow up.

Lynch undated No assessment of effect of ozone on caries.

Marashdeh 2003 Less than 6 months follow up.

Megighian 2003A Less than 6 months follow up.

Megighian 2003B Attitude and satisfaction survey, no randomisation.

Morrison 2003A Less than 6 months follow up.

Morrison 2003B Less than 6 months follow up.

Reaney 2003 Less than 6 months follow up.

Reaney undated Less than 6 months follow up.

Sandhaus 1965 Not a randomised trial.

Stinson 2003A Less than 6 months follow up.



(Continued)

Stinson 2003B Less than 6 months follow up.

Stinson undated Less than 6 months follow up.



D A T A A N D A N A L Y S E S

This review has no analyses.

A D D I T I O N A L T A B L E S

Table 1. Results of the included studies, caries regression and progression

Study Measure Ozone N, mean (SD) Control N, mean (SD)

Abu-Naba’a 2003 main Clinical severity index*, change

from baseline, 6 months follow up

102, 0.22 (0.65) 102, 0.29 (0.68)

Abu-Naba’a 2003 main Log(e) ECM score*, change from

baseline, 6 month follow up

104, 0.29 (1.55) 104, -0.23 (1.45)

Abu-Naba’a 2003 main Log

(e) DIAGNOdent score*, change

from baseline, 6 month follow up

100, 0.05 (0.44) 103, 0.09 (0.50)

Abu-Naba’a 2003 main Clinical severity index*, change

from baseline, 12 months follow

up

106, 0.28 (0.64) 106, 0.44 (0.74)

Abu-Naba’a 2003 main Log(e) ECM score*, change from


109, 0.02 (1.40) 109, 0.07 (1.61)

Abu-Naba’a 2003 main Log(e) DIAGNOdent score*,

change from baseline, 12 month

follow up

105, 0.10 (0.58) 107, 0.08 (0.54)

Abu-Naba’a 2003 pilot Clinical severity score* Baseline: 19, 2.2 (0.76) 6 months:

13, 2 neg ranks, 0 pos ranks, 11

ties

Baseline: 19, 2.0 (0.67) 6 months:

12, 5 neg ranks, 0 pos ranks, 7 ties

Abu-Naba’a 2003 pilot Log

(e) DIAGNOdent score*, change

from baseline, 6 month follow up

Baseline: 19, 3.2 (0.92) Change to

6 months: 12, 0.1, 0.28


6 months: 11, -0.05, 0.27

Abu-Naba’a 2003 pilot Log(e) ECM score*, change from



6 months: 12, 0.3, 1.39


6 months: 11, 0.4, 0.63

Abu-Naba’a 2003 pilot Visual index, (1 = sound, 2 = car-

ious, 3 = arrested)

6 months: 13, 0 neg ranks, 8 pos

ranks, 5 ties


ranks, 11 ties

Abu-Naba’a 2003 pilot Colour of lesion (1 = yellow, 2 =

light brown, 3 = grey, 4 = dark

brown, 5 = black)


ranks, 8 ties


ranks, 4 ties



Table 1. Results of the included studies, caries regression and progression (Continued)

Abu-Naba’a 2003 pilot Cavitation index (after further

plaque removal by probe and dry-

ing, 1 = no cavitation, 2 = micro-

cavitation, 3 = frank cavitation)


ranks, 7 ties


ranks, 7 ties

Abu-Naba’a 2003 pilot Hardness index (1 = hard as adja-

cent sound pit or fissure, 2 = leath-

ery, 3 = soft)


ranks, 2 ties


ranks, 7 ties

Abu-Naba’a 2003 pilot Perceived treatment need index

(1 = definitely requires drilling

and filling [D&F], 2 = possi-

bly requires D&F or preventive

resin restoration [PRR], 3 = re-

quires pharmaceutical approach

(not D&F or PRR), 4 = requires

no intervention)


ranks, 2 ties


ranks, 2 ties

Abu-Naba’a 2003 pilot Frostiness of enamel at margins

(mm)

Unclear Unclear

Abu-Naba’a 2003 pilot Enamel undermining shade (mm) Unclear Unclear

Baysan 2003 ECM measurement**, final read-

ing, 6 month follow up

?, 5.62 (0.12) ?, 4.92 (0.21)

Baysan 2003 DIAGNOdent measurement*, fi-

nal reading, 6 month follow up

?, 10.9 (2.4) ?, 46.4 (2.2)

* Lower readings or negative changes imply remineralisation, or protection from caries

** Higher readings imply remineralisation, or more protection from caries



A P P E N D I C E S

Appendix 1. MEDLINE (OVID) search strategy

1 ozone$.mp.

2 exp OZONE/

3 O3.mp.

4 (curozone$ or healozone$).mp.

5 1 or 2 or 3 or 4

6 exp Tooth Demineralization/

7 (caries or carious or deminerali$ or de-minerali$).mp

8 exp Dentistry, Operative/

9 ((teeth or tooth or dental or enamel or dentin$) and (caries or carious or decay$ or lesion$ or deminerali$ or reminerali$ or white

spot lesion$)).mp

10 ((caries or “dental caries” or decay or enamel) and (prevent$ or control$ or reminerali$ or arrest$)).mp

11 exp Dental Caries Activity Tests/

12 exp Dental Caries Susceptibility/

13 exp Dental Enamel Solubility/

14 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13

15 5 and 14

W H A T ’ S N E W

Last assessed as up-to-date: 13 May 2004.

Date Event Description

12 August 2008 Amended Converted to new review format.

H I S T O R Y

Protocol first published: Issue 2, 2003

Review first published: Issue 3, 2004

C O N T R I B U T I O N S O F A U T H O R S

George David Rickard (GDR), Robin Richardson (RR), Trevor Johnson(TJ), David McColl (DM) and Lee Hooper (LH) designed

the review and wrote the protocol with Anne-Marie Glenny (AMG) and Jan Clarkson. GDR co-ordinated the review. LH and AMG

developed the search strategy and undertook searches. GDR, RR, TJ, DM and LH screened the search results. LH organised retrieval

of papers. GDR, RR, TJ, DM and LH screened retrieved papers against inclusion criteria. GDR, RR, TJ, and LH appraised study

quality and extracted data from included papers. GDR, RR, and LH wrote to authors for additional information. GDR managed the

review data. GDR, RR and LH wrote the body of the review, and interpreted the data. GDR, RR, TJ and DM wrote the discussion.



D E C L A R A T I O N S O F I N T E R E S T

None known. None of the authors has ever acted as a consultant for, or been funded in any way by Kavo Dental GmbH & Co. KG the

company that manufactures the ozone delivery equipment. The faculty course was sponsored by 3M/ESPE (who have had no input

into or influence on, this review).

S O U R C E S O F S U P P O R T

Internal sources

• Cochrane Oral Health Group, UK.

• University of Manchester, UK.

• Central Manchester and Manchester Children’s University Hospitals NHS Trust, UK.

External sources

• 3M sponsored several places on the course that lead to this systematic review being developed, UK.

I N D E X T E R M S

Medical Subject Headings (MeSH)

Cariostatic Agents [∗therapeutic use]; Dental Caries [∗drug therapy]; Dental Fissures [drug therapy]; Ozone [∗therapeutic use]; Ran-

domized Controlled Trials as Topic

MeSH check words

Humans



ozone therapy for the treatment of dental caries

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