Cochrane Rev FL Slow Release

Slow-release fluoride devices for the control of dental decay
(Review)
Bonner BC, Clarkson JE, Dobbyn L, Khanna S
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2008, Issue 4
http://www.thecochranelibrary.com
Slow-release fluoride devices for the control of dental decay (Review)

Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
ACKNOWLEDGEMENTS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11
Analysis 1.1. Comparison 1 Slow-release fluoride device versus placebo, Outcome 1 Increase in DMFT at 2 years compared
to baseline. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11
Analysis 1.2. Comparison 1 Slow-release fluoride device versus placebo, Outcome 2 Increase in DMFS at 2 years compared
to baseline. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13
INDEX TERMS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13

[Intervention Review]

Brian C Bonner1 , Jan E Clarkson1 , Lorna Dobbyn2 , Smriti Khanna3
1 Dental
Health Services Research Unit, University of Dundee, Dundee, UK. 2 Dundee Dental School and Hospital, University of
Dundee, Dundee, UK. 3 Sheffield, UK
Contact address: Brian C Bonner, Dental Health Services Research Unit, University of Dundee, The Mackenzie Building, Kirsty Semple
Way, Dundee, Tayside, DD2 4BF, UK. b.c.bonner@dundee.ac.uk.
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: 8 August 2006.
Citation: Bonner BC, Clarkson JE, Dobbyn L, Khanna S. Slow-release fluoride devices for the control of dental decay. Cochrane
Database of Systematic Reviews 2006, Issue 4. Art. No.: CD005101. DOI: 10.1002/14651858.CD005101.pub2.
ABSTRACT
Background
Slow-release fluoride devices have been investigated as a potentially cost-effective method of reducing dental caries in those with high
risk of disease.
Objectives
To evaluate the effectiveness of different types of slow-release fluoride devices on preventing, arresting, or reversing the progression of
carious lesions on all surface types of deciduous and permanent teeth.
Search strategy
We searched (up until February 2005) multiple electronic databases (Cochrane Oral Health Groups Trials Register, CENTRAL,
MEDLINE, EMBASE), bibliographic references of identified randomised controlled trials (RCTs), textbooks, review articles, and
meta-analyses. Letters were sent to authors of identified RCTs asking for clarifications and unpublished or ongoing research. Relevant
journals were handsearched for more recent reports than those obtained from databases.
Selection criteria
Randomised or quasi-randomised controlled trials (RCTs) comparing slow-release fluoride devices with an alternative fluoride treatment,
placebo, or no intervention in all age groups. The main outcomes measures sought were changes in numbers of decayed, missing, and
filled teeth or surfaces (DMFT/DMFS in permanent teeth or dmft/dmfs in primary teeth) and progression of carious lesions through
enamel and into dentine.
Data collection and analysis
Abstracts of all reports identified were considered independently by two review authors and full reports obtained of any potentially
relevant articles to allow further assessment for relevance and validity. Data extraction and quality assessment were conducted independently by two and three review authors respectively, with arbitration by the fourth. Where uncertainty existed, authors were contacted
for additional information.
Main results
Only one trial involving 174 children fully met the criteria for inclusion in this review. Although 132 children were still included in
the trial at the 2-year completion point, examination and statistical analysis was performed on only the 63 children who had retained
the beads. Thirty-one of these were in the intervention group and 32 in the control group.
Amongst these 63 children, caries increment was reported to be statistically significantly lower in the intervention group than in the
placebo group (mean difference: -0.72 DMFT, 95% confidence interval -1.23 to -0.21 and -1.52 DMFS, 95% confidence interval 2.68 to -0.36)
Authors conclusions
There is some evidence of a caries-inhibiting effect of slow-release fluoride glass beads. This evidence is regarded as weak and unreliable
because the results were from participants selected on the basis of bead retention rather than an intention-to-treat analysis.
PLAIN LANGUAGE SUMMARY

Slowly dissolving fluoride-releasing glass beads may help reduce dental decay if retained in the mouth over time, but retention of the
beads is a problem.
This review concludes that slow-release fluoride devices have the potential to protect against tooth decay if they can be kept in place, in
the mouth, for 2 years. The evidence, so far, is considered to be weak and unreliable. In a single study a reduction of 0.72 in mean caries
increment (assessed as decayed, filled, or missing teeth) compared to control was reported (caries increment in the intervention group
was 0.19 versus 0.91 in the control group). However, this analysis excluded 52% of available participants, whose beads had become
dislodged.
BACKGROUND
Dental decay is not distributed evenly amongst the population.
In epidemiological surveys in Scotland, for example, it has been
seen that 50% of the disease can be accounted for by including
only 11% of 5-year-olds and only 6% of 14-year-olds (DHSRU
2003; Pitts 1999). In light of this uneven distribution, it is often
advocated that these small percentages of children may be offered
targeted caries preventive measures to great potential effect, in a
cost effective manner. Some have cautioned, however, that such
targeted interventions may fail to effect real change if they require
the targeted individuals to adopt different social norms from their
peers (Batchelor 2002). Fluoride has been shown to be valuable
not only in the prevention of caries but also in reversal and remineralisation of lesions (Biesbrock 1998). However, this would
appear to be a slow process requiring the presence of fluoride in the
mouth for extended periods of time (Rolla 1990) and the low concentrations found after brushing with fluoride-containing denti-
frice may not be sufficient to significantly reduce the dissolution

of tooth mineral (ten Cate 1999).
There are a number of ways of delivering supplemental fluoride
including tablets, mouthrinses, fluoridated salt, toothpastes, gels,
and varnishes. Several of these have been the subject of recent
Cochrane reviews (Marinho 2002a; Marinho 2002b; Marinho
2003a; Marinho 2003b). A number of devices have been used
to provide a slowly released, more sustained presence of fluoride
within the buccal cavity showing that it is possible to sustain elevated levels of fluoride within saliva and plaque (Mirth 1982).
Various materials have shown potential for release of fluoride into
the mouth including amalgam (Fazzi 1977), acrylic plates (Harary
1984), cements (Masuhara 1985), resins (Cooley 1988), sealants
(Cooley 1990), fluoride-releasing elastomerics (Banks 2000), and
glass ionomer cements (Hatibovic 1991). In terms of the desired
properties of fluoride-releasing devices (Toumba 2001), from this

list, only glass ionomer cements meet the criterion of long-term

fluoride release of at least 1 year. Two types of intraoral fluoride
slow-release device are currently in use, the copolymer membrane
(Cowsar 1976) and slowly dissolving fluoride glass beads (Toumba
1993). The glass beads, which are 4 mm in diameter, are attached
to the buccal aspect of molar teeth using acid-etch composite. The
percentage of incorporated fluoride can be adjusted to vary the
amount released and have been shown to lead to raised salivary
fluoride levels for up to 2 years (Toumba 1993).
Concerns that accidental swallowing of fluoride-containing devices might lead to gastric irritation or adverse effects following
raised plasma fluoride concentrations were addressed in a study
reported in 1994 (Curzon 2004). Glass beads constituted with
13.3% fluoride (F-) were deliberately swallowed by five adult volunteers and their venous blood was subsequently drawn and analysed at intervals. Plasma fluoride concentration did not rise from
baseline during 2 hours of monitoring in contrast to fluoride
tablets, which gave a detectable increase peaking after 20 to 30
minutes. Based on this finding, they concluded that fluoride released from slow-dissolving glass did not present a health risk.
The purpose of this review was to determine, if possible, the clinical
effectiveness of slow-release fluoride devices for halting, or slowing,
the progression of enamel, dentine, and carious root lesions on
different tooth surfaces of deciduous and permanent teeth. It is
anticipated that if such slow-fluoride releasing devices did prove to
be clinically effective they would primarily be offered to children
regarded as being at high risk of developing dental caries.
OBJECTIVES
Main objective
To evaluate the effectiveness of different types of slow-release fluoride devices on preventing, arresting, or reversing the progression
of carious lesions on all surface types of deciduous and permanent
teeth.
To test the null hypothesis that there is no difference between
the proportion of patients with new, arrested, or reversed lesions
and/or mean number of (new) lesions per patient in patients fitted
with slow-release fluoride devices compared with a group receiving
no intervention/placebo against the alternative hypothesis of a
difference.
To test the null hypothesis that there is no difference between the
mean proportion/number of lesions in patients receiving different
types of slow-release fluoride devices or alternative means of fluoride delivery against the alternative hypothesis of a difference.
Criteria for considering studies for this review
Types of studies
Randomised or quasi-randomised controlled trials (RCTs) in
which slow-release fluoride devices were compared concurrently
to an alternative fluoride treatment, placebo, or no intervention
group. RCTs were considered for inclusion irrespective of publication status, language, or blinding. Split-mouth trials were not
included because the treatment applied to one half may have contaminated the other part of the mouth.
Types of participants
Children or adults.
Types of interventions
Randomised or quasi-randomised controlled trials (RCTs) comparing slow-release fluoride devices with an alternative fluoride
treatment, placebo, or no intervention in all age groups. All types
of slow-release fluoride device were considered. However, currently
the only substances which can release fluoride over a sufficient
period are copolymer acrylic reservoir types and slowly-dissolving
glass beads.
Types of outcome measures
Primary outcomes
(1) The changes in decayed, missing, and filled teeth or surfaces or

both (DMFT/DMFS in permanent teeth - dmft/dmfs in primary
teeth).
(2) Progression of caries lesion through enamel or into dentine.
Secondary outcomes
(1) Time taken to fit slow-release devices.

(2) Number of visits to the dentist for attention to or refitting of
slow-release devices.
(3) Cost effectiveness of slow-release devices.
(4) Patient satisfaction.
(5) Harms of slow-release devices.
Search methods for identification of studies

For the identification of the studies included or considered for this
review, search strategies were employed for a number of databases.
Searches were conducted for potential randomised controlled trials
(RCTs) in:
METHODS
the Cochrane Oral Health Groups Trials Register (to

February 2005)
the Cochrane Central Register of Controlled Trials
(CENTRAL) (The Cochrane Library 2005, Issue 1)
MEDLINE (1966 to February 2005)
EMBASE (1980 to February 2005)
Current Controlled Trials (www.controlled-trials.com).
Data extraction
An itemised form was used to ensure consistency of data extraction
between studies and between assessors. The extraction was carried
out, in triplicate, independently by BB, LD, and SK and in case
of discrepancies a consensus was sought by discussion with JC.
Quality assessment
Bibliographic references of identified RCTs, textbooks, review articles, and meta-analyses were also checked. In addition, letters
were sent to authors of identified RCTs or apparent RCTs asking
them for clarifications and other known unpublished or ongoing
research. There was no restriction regarding language or date of
publication or publication status. A sensitive search strategy using
controlled vocabulary and free text terms was developed for each
database around the search strategy included in Appendix 1.
Journals in which the review authors considered trials in this field
were likely to be reported were identified and found to be included
within the Cochrane handsearching scheme. These handsearches
were complete up to various dates between 2000 and 2002. One
author (Brian Bonner (BB)) handsearched more recent issues of
these journals (up to February 2006).
Data collection and analysis

Every step of the review was done in the Review Manager
(RevMan) software provided by The Cochrane Collaboration. The
quality of the studies included was assessed according to the criteria described in the Cochrane Handbook for Systematic Reviews of
Interventions 4.2.5 (Higgins 2005).
Selection of potentially eligible studies

The titles and abstracts of all reports identified by the online
searches were printed out and assessed independently by two review authors (Brian Bonner (BB) and Lorna Dobbyn (LD)) on
the basis of title, keywords, and abstract (when this was available)
to see if the study was likely to be relevant. The full report was obtained of all relevant articles. Where it was not possible to classify
an article, the full article was obtained.
The quality assessment of included trials was undertaken independently, in triplicate, by BB, LD, and Smriti Khanna (SK) as part of
the data extraction process and in accordance with the guidelines
in the Cochrane Handbook for Systematic Reviews of Interventions
4.2.5 (Higgins 2005). Any disagreements were resolved by discussion with JC.
The following were included in the quality assessment:
Randomisation procedure was recorded and allocation concealment was recorded as (A) adequate, (B) unclear, (C) inadequate,
or (D) not used (as described in the Cochrane Handbook for Systematic Reviews of Interventions 4.2.5). Further quality assessment was
carried out to assess blinding of outcome assessment, completeness of follow up (clear explanations for withdrawals, drop outs,
and protocol deviations in intervention and control groups), and
intention-to-treat analysis. Where there was uncertainty over data,
the study author(s) were contacted to seek clarification. Randomisation and allocation measures were clarified with Dr Ida Marini (
Marini 1999), the existence of a pending paper reporting, in more
detail, on the single study included in this review was discovered
after correspondence with Professor Toumba (Toumba 2005), and
an unsuccessful enquiry was made to discover more details about
a study titled Fluoride controlled release systems in prevention of
dental caries apparently conducted in Parma, Italy.
After taking into account any additional information provided
by the authors of the trials, studies were grouped based on the
following categorisation.
(A) Low risk of bias (plausible bias unlikely to seriously affect the
results) if all criteria were met.
(B) Moderate risk of bias (plausible bias which raises some doubt
about the validity of the results) if one or more of the criteria were
partly met (for instance if authors responded that some attempt
was made to conceal the allocation of patients, to blind assessors,
or to give explanations for withdrawals but these attempts were
not judged to be ideal, these criteria were categorised as partly
met).
(C) High risk of bias (plausible bias which seriously weakens confidence in the results) when one or more criteria were not met.
Study inclusion criteria

The review authors were not blinded with respect to report authors, journals, date of publication, sources of financial support,
or results. The inclusion criteria were applied, in duplicate, independently by two review authors (BB and LD) and opinions
compared afterwards in discussion with Jan Clarkson (JC).
Data analysis
Data analysis was guided by the Cochrane Handbook for Systematic
Reviews of Interventions 4.2.5 (Higgins 2005). For the continuous
outcome measures, analysed in this review, means and standard
deviations were used to summarise the data for each group.

Random-effects modelling was to be used in analyses. However,

it was not possible to undertake comparisons between studies as
only a single study was included within the analysis.
In addition, it was not possible to undertake subgroup analysis
between results for different tooth surfaces (enamel, dentine, and
root surface), amount of fluoride released and duration of exposure, adults/children, or length of follow up, as this information
was not available.
The inclusion of a single study precluded sensitivity analysis to
judge whether conclusions would be affected by different inclusion
criteria.
utilised portable dental equipment set up in seven primary schools

in Beeston, Leeds.
Characteristics of the participants

See Characteristics of included studies table for further details.
(Toumba 2005). Participants had a mean age of 8.8 years at the
beginning of the study and 10.9 at the termination. Number of
decayed, missing and filled teeth (DMFT in permanent teeth or
dmft in primary teeth) greater than 1 at the start of the study and
greater than 1 million colony forming units of mutans Streptococci
per ml of saliva.
Improving and updating reviews

The review will be updated every 2 years. Even if no substantial
evidence is found and no amendment is needed, the results of the
last search will be clearly stated.
RESULTS
Characteristics of the interventions

(Toumba 2005). Glass beads were attached to buccal surfaces of
right maxillary first permanent molar teeth. In the intervention
group, glass beads were constituted with fluoride (F-) which was
designed to be released slowly as the glass dissolved in the mouth.
In the control group, the glass was manufactured without F-.
Changes in dmf (DMF)
Description of studies
See: Characteristics of included studies; Characteristics of excluded
studies.
Summary details are provided in the Characteristics of included
studies and Characteristics of excluded studies tables.
(Toumba 2005). Comparisons were made between scores for decayed, missing, and filled teeth and surfaces (dmft/dmfs in primary teeth, DMFT/DMFS in permanent teeth) in intervention
and control groups at baseline, mid-study, and at termination (2
years). At the end of the study period, caries increments were compared separately and combined for decayed, missing, and filled
teeth and surfaces, and also specifically on occlusal surfaces.
Search results, excluded and included studies

Initial searches of all sources yielded a total of 73 titles and abstracts. Following assessment for eligibility, the full texts of six papers were considered potentially relevant to this review. Two of
the six papers described the same study, namely Toumba 2001
and Toumba 2005. One of the authors of these papers, Professor
Toumba, argued that the 2001 paper was not intended to be a
research report and, consequently, only the latter, fuller paper was
included in this review. The other four potentially relevant studies
were excluded on the grounds of not being a randomised controlled trial (RCT) (Aaltonen 2000; De Los Santos 1994), inadequate randomisation (Marini 1999; Trimpeneers 1996), or being
a split-mouth study (Trimpeneers 1996).
Characteristics of the trial and settings of the

investigators
Toumba 2005 was conducted exclusively in an area of deprivation
in an inner-city area of Leeds, UK (postcode LS11). All examinations and placement of devices were by one investigator and
Progression of caries into enamel or dentine

No data presented on this topic.
Patient satisfaction
No data presented on this topic.
Harms
Patient harm was not measured or discussed within the trial report (Toumba 2005). Slowly-dissolving glass beads similar to those
used in the study are used commercially to deliver mineral supplements in livestock. Since the adaptation of these devices for
dental purpose in man, the same authors have tested, in a limited
way, the potential effect of swallowing fluoride containing slowdissolving beads on enteric absorption of fluoride (Curzon 2004).
Plasma fluoride concentration did not rise from baseline during
2 hours of monitoring in contrast to fluoride tablets, which gave
a detectable increase peaking after 20 to 30 minutes. From this

result, they concluded that fluoride released from slow-dissolving

glass does not present a health risk.
Risk of bias in included studies

(Toumba 2005). The methods of randomisation and concealment
of allocation were clearly explained and were adequate to guard
against bias (A). We have been assured that the examiner remained
blinded to the study group until the final examinations had been
carried out.
Of concern was the high level of attrition in participant number.
The acknowledged number of drop outs was a modest 15, however
only 63 of the original 174 participants were included in the final
analysis. Subjects whose beads had dislodged were not assessed for
dental disease within the study. The total loss to follow up was
thus 64%. Although the control (n = 32) and test (n = 31) groups
held similar numbers in the end of study assessment, the review
authors consider that the validity of an extrapolation, from this
trial to any potential use of this technique in the prevention of
caries in practice, requires analysis to be based on all participants.
We therefore consider that there is a high risk of bias (C).
Effects of interventions
DISCUSSION
Although a number of slow-release fluoride devices have been devised, the lack of well controlled studies into the effectiveness of
these is disappointing.
The one study accepted for this review has shown some evidence
for a reduction in dental disease progression in high-risk children.
However, the exclusion of the majority of participants from the
statistical analysis marks the evidence presented as weak and unreliable (Newell 1992).
The study involved a limited number of participants from a defined high-risk population and points the way towards the need
for a larger, more general, trial. The question of retention of the
devices in place also needs to be addressed. For orthodontic brackets, overall bonding failure rate was found to be 8% but three times
greater in children under the age of 12 (Millett 1994). The discussion section of the included study report (Toumba 2005) indicated
there was a particular problem with children deliberately setting
out to dislodge their bonded glass beads, but that improvements
in bonding techniques are already being explored. These include
the factoring of a retention groove around the periphery of the
bead which, it is claimed, improves retention (Welbury 2003)
AUTHORS CONCLUSIONS
Implications for practice
Comparison of slow-release device versus placebo

(Toumba 2005). One hundred and thirty-two out of 174 children
recruited to the study were still included at 2 years, but only 63
children still had beads attached. Those 63 children alone were
included in the comparisons (31 test and 32 control). Caries increment was reported to be significantly lower in the intervention
group than in the placebo group (mean difference: -0.72 decayed,
missing, and filled permanent teeth (DMFT), 95% confidence interval -1.23 to -0.21 and -1.52 decayed, missing, and filled permanent surfaces (DMFS), 95% confidence interval -2.68 to -0.36).
Mean salivary fluoride was significantly higher in those (of the 63)
fitted with the fluoride-releasing beads than placebo when determined at the 1 year mid-point and at the study end-point (1 year,
test 0.15 mg L1 control 0.05 mg L1 ; 2 years, test 0.11 mg L1
control 0.03 mg L1 ).
Clinical assessment of decayed, missing and filled teeth and surfaces in primary teeth (dmft and dmfs) was also reported in this
study (Toumba 2005). However, the data were not considered to
be usable as it was unclear how the quoted mean caries increment
for dmft/dmfs over the 2 years related to the values given at the
three-time points and the study authors were unable to provide
clarification. In addition, information regarding caries experience
of the 52% of participants not included in the analysis could not
be obtained.
We conclude that there is, as yet, only weak and unreliable evidence that slow-release fluoride devices in the mouth may provide a measure of protection against dental disease progression (
Toumba 2005). The generalisability of these findings to routine
dental practice is questioned by the difficulties of retention of the
devices. Clearly, once the beads have been dislodged they are no
longer useful. In addition, the beneficial effects seen might prescribe careful selection of the target recipients to be cost-effective.
Implications for research

Studies identified for this review have not provided reliable evidence to answer the main question of the review. Some limited
evidence was found but weaknesses in this were evident. To remedy these weaknesses, much larger, well-conducted trials should
be carried out. These trials should, perhaps, draw comparisons
between available alternatives such as gels or varnishes and should
provide analysis of results on the basis of intention-to-treat and
consider costs and benefits. One of the authors of the included
study has previously concluded that the use of slow fluoride-releasing glass beads is a cost-effective technique (Toumba 1997).
The included study (Toumba 2005) focused on children from a
poor area. A future trial should include participants from different
risk categories to help to gauge how useful the technique would
be likely to be, generally. It may be of benefit to establish how

much fluoride should be released from the devices for optimum

effect. Different materials and methods used for bonding may influence the efficacy of fluoride release as well as the strength of the
bonding. Future studies might include consideration of bonding
methods and the use of slow-release devices contoured to provide
a better match to that of the tooth surface.
ACKNOWLEDGEMENTS
We wish to acknowledge the help of Sylvia Bickley in the design of
the search strategy and the Cochrane Oral Health Review Group
Editorial Team.
REFERENCES
References to studies included in this review

Toumba 2005 {published data only}
Toumba KJ, Curzon ME. A clinical trial of a slow-releasing fluoride
device in children. Caries Research 2005;39(3):195200. [: DOI:
10.1159/000084798]
References to studies excluded from this review

Aaltonen 2000 {published data only}
Aaltonen AS, Suhonen JT, Tenovuo J, Inkila-Saari I. Efficacy of a
slow-release device containing fluoride, xylitol and sorbitol in
preventing infant caries. Acta Odontologica Scandinavica 2000;58
(6):28592.
De Los Santos 1994 {published data only}
De Los Santos R, Lin YT, Corpron RE, Beltran ED, Strachan DS,
Landry PA. In situ remineralization of root surface lesions using a
fluoride chewing gum or fluoride-releasing device. Caries Research
1994;28(6):4416.
Marini 1999 {published data only}
Marini I, Pelliccioni GA, Vecchiet F, Alessandri Bonetti G, Checchi
L. A retentive system for intra-oral fluoride release during
orthodontic treatment. European Journal of Orthodontics 1999;21
(6):695701.
Trimpeneers 1996 {published data only}
Trimpeneers LM, Dermaut LR. A clinical evaluation of the
effectiveness of a fluoride-releasing visible light-activated bonding
system to reduce demineralization around orthodontic brackets.
American Journal of Orthodontics and Dentofacial Orthopedics 1996;
110(2):21822.
Additional references
Banks 2000
Banks PA, Chadwick SM, Asher-McDade C, Wright JL. Fluoridereleasing elastomerics - a prospective controlled clinical trial.
European Journal of Orthodontics 2000;22(4):4017.
Batchelor 2002
Batchelor P, Sheiham A. The limitations of a high risk approach
for the prevention of dental caries. Community Dentistry and Oral
Epidemiology 2002;30(4):30212.
Biesbrock 1998
Biesbrock AR, Faller RV, Bartizek RD, Court LK, McClanahan SF.
Reversal of incipient and radiographic caries through the use of
sodium and stannous fluoride dentifrices in a clinical trial. Journal
of Clinical Dentistry 1998;9(1):510.
Cooley 1988
Cooley RL, Sandoval VA, Barnwell SE. Fluoride release and color
stability of a fluoride-containing composite resin. Quintessence
International 1988;19(12):899904.
Cooley 1990
Cooley RL, McCourt JW, Huddleston AM, Casmedes HP.
Evaluation of a fluoride-containing sealant by SEM, microleakage,
and fluoride release. Pediatric Dentistry 1990;12(1):3842.
Cowsar 1976
Cowsar D, Tarwater O, Tanquary A. Controlled release of fluoride
from hydrogels for dental applications. Andrade JD, editor(s).
Hydrogels for medical and related applications. Vol. 31, Washington,
USA: American Chemical Society, 1976:18097.
Curzon 2004
Curzon ME, Toumba KJ. In vitro and in vivo assessment of a glass
slow fluoride releasing device: a pilot study. British Dental Journal
2004;196(9):5436.
DHSRU 2003
Dental Health Services Research Unit. Scotlands National Dental
Inspection Programme 2003.
Fazzi 1977
Fazzi R, Vieira DF, Zucas SM. Fluoride release and physical
properties of a fluoride-containing amalgam. Journal of Prosthetic
Dentistry 1977;38(5):52631.
Harary 1984
Harary D, Friedman M. Enhancement of fluoride concentration in
saliva after topical application of fluoride sustained-release dosage

form on orthodontic plates. Journal of Pharmocological Science

1984;73(1):1356.
Hatibovic 1991
Hatibovic-Kofman S, Koch G. Fluoride release from glass ionomer
cement in vivo and in vitro. Swedish Dental Journal 1991;15(6):
2538.
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Higgins JPT, Green S, editors. Cochrane Handbook for Systematic
Reviews of Interventions 4.2.5 [updated May 2005]. The Cochrane
Library, Issue 3 2005. Chichester, UK: John Wiley & Sons, Ltd.
Marinho 2002a
Marinho VCC, Higgins JPT, Logan S, Sheiham A. Fluoride gels for
preventing dental caries in children and adolescents. Cochrane
Database of Systematic Reviews 2002, Issue 1. [Art. No.:
CD002280. DOI: 10.1002/14651858.CD002280]
Marinho 2002b
Marinho VCC, Higgins JPT, Logan S, Sheiham A. Fluoride
varnishes for preventing dental caries in children and adolescents.
Cochrane Database of Systematic Reviews 2002, Issue 1. [Art. No.:
CD002279. DOI: 10.1002/14651858.CD002279]
Marinho 2003a
toothpastes for preventing dental caries in children and adolescents.
Cochrane Database of Systematic Reviews 2003, Issue 1. [Art. No.:
CD002278. DOI: 10.1002/14651858.CD002278]
Marinho 2003b
mouthrinses for preventing dental caries in children and
adolescents. Cochrane Database of Systematic Reviews 2003, Issue 3.
[Art. No.: CD002284. DOI: 10.1002/14651858.CD002284]
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Masuhara E, Kadoma Y, Fujisawa S. Current status of release of
fluoride ions and other bioactive agents from dental materials:
prospects for controlled release. Critical Reviews in Therapeutic
Drug Carrier Systems 1985;1(2):91119.
Millett 1994
Millett DT, Gordon PH. A 5-year clinical review of bond failure
with a no-mix adhesive (Right on). The European Journal of
Orthodontics 1994;16(3):20311.
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Mirth DB, Shern RJ, Emilson CG, Adderly DD, Li SH, Gomez
IM, et al.Clinical evaluation of an intraoral device for the controlled
release of fluoride. Journal of the American Dental Association 1982;
105(5):7917.
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Newell DJ. Intention-to-treat analysis: implications for quantitative
and qualitative research. International Journal of Epidemiology 1992;
21(5):83741.
Pitts 1999
Pitts NB, Nugent ZJ, Smith PA. The Scottish Health Boards Dental
Epidemiological Programme Report of the 1998/1999 survey of 14year-old children. Dundee, UK: University of Dundee, 1999.
Rolla 1990
Rolla G, Saxegaard E. Critical evaluation of the composition and
use of topical fluorides, with emphasis on the role of calcium
fluoride in caries inhibition. Journal of Dental Research 1990;69
(Spec No):7805.
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ten Cate JM. Current concepts on the theories of the mechanism of
action of fluoride. Acta Odontologica Scandinavica 1999;57(6):
3259.
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Toumba KJ, Curzon ME. Slow-release fluoride. Caries Research
1993;27 Suppl 1:436.
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Toumba KJ, Curzon ME. Cost-effectiveness and benefit-cost of a
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Toumba KJ. Slow-release devices for fluoride delivery to high-risk
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(May-June):189.
Indicates the major publication for the study

CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]

Toumba 2005
Methods
Participants in control and test groups were fitted with glass bead devices of identical appearance which
either did or did not release fluoride ions into the saliva. Glass beads were in containers coded by a third
party (using a random numbers table) and neither the investigator nor the participants were aware of
which type were fitted to each individual. 1 spare device was provided in each container and replacement
was permitted, in the case of dislodgment, for up to 4 months from the start of the study.
All examinations and device placement was by 1 investigator who demonstrated his reliability of assessments (Kappa 0.86 for caries and 0.76 for periodontal indices) on a group of 25 children.
Participants
174 children selected from a defined population attending 1 of 7 schools, residing in postcode LS11
(inner city, Leeds), being born in 1983, having dmft or DMFT greater than 1 and greater than 1 million
Streptococcus mutans (cfu) per ml of saliva, and not having medical contra-indications.
132 children were still in the trial at the 2-year completion point. However, the statistical analysis was
performed on outcomes from the 63 children, 31 intervention and 32 control, who had retained the fitted
glass beads to the study end-point.
Interventions
Glass beads were attached to buccal surfaces of right maxillary first permanent molar. The tooth surface
was cleaned with fluoride-free paste (washed and dried), the cleaned surface etched with 40% phosphoric
acid gel (washed and dried), and Scotchbond, light-cure bonding agent was applied thinly to both tooth
surface and bead. The glass device was then attached to the tooth using Herculite, universal shade, lightcuring composite resin.
In the intervention group, glass beads were constituted with F- which was designed to be released slowly
as the glass dissolved in the mouth.
In the control group, the glass was manufactured without F-.
Outcomes
Dental caries was assessed at baseline, at 1 year, and at 2 years.

Gingival health was measured as periodontal health, cleanliness, and presence of calculus.
Streptococcus mutans counts were determined at baseline, at 1 year, and at 2 years.
Unstimulated whole mixed saliva, taken 2 hours post-prandial, was collected at the time of dental examination and analysed for fluoride concentration at baseline, at 1 year, and at 2 years.
Notes
Study area was one of social deprivation and low level of dental care. The tap water in area had less than
0.1 mg of F- per litre and dental caries was amongst highest in UK.
Examinations and device fitment was carried out on school premises using portable dental equipment.
The trial was supported by a grant from the Wolfston Foundation.
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Yes
A - Adequate
dmft = decayed, missing, and filled primary teeth

DMFT = decayed, missing, and filled permanent teeth
F- = fluoride
Characteristics of excluded studies [ordered by study ID]
Aaltonen 2000
Extremely confused study in which patients were re-assigned to control or test during the study. Randomisation,
allocation concealment, and blinding were all inadequate.
De Los Santos 1994
Although this was a study of a fluoride-releasing device, it was not an RCT but a very short-time study
involving 6 subjects only fitted with prepared third-molar extracts restrained by using acrylic holders.
Marini 1999
Randomisation and allocation measures were inadequate. There appeared to have been a single operator who
was also the single outcome assessor. As control subjects were not fitted with a dummy device it was hard to
see how the assessment could have been unbiased. Author classifies the study as double-blind but has failed to
show any evidence of blinding.
Trimpeneers 1996
This was a split-mouth study. All subjects received both treatments at the same time.
RCT = randomised controlled trial

10
DATA AND ANALYSES
Comparison 1. Slow-release fluoride device versus placebo
Outcome or subgroup title

1 Increase in DMFT at 2 years
compared to baseline
2 Increase in DMFS at 2 years
compared to baseline
No. of
studies
No. of
participants
63
Mean Difference (IV, Random, 95% CI)
-0.72 [-1.23, -0.21]
63
Mean Difference (IV, Random, 95% CI)
-1.52 [-2.68, -0.36]
Statistical method
Effect size
Analysis 1.1. Comparison 1 Slow-release fluoride device versus placebo, Outcome 1 Increase in DMFT at 2
years compared to baseline.
Review:
Comparison: 1 Slow-release fluoride device versus placebo

Outcome: 1 Increase in DMFT at 2 years compared to baseline
Study or subgroup
Fluoride
Placebo
Mean Difference
Mean(SD)
Mean(SD)
Toumba 2005
31
0.19 (0.56)
32
0.91 (1.36)
Total (95% CI)
31
Weight
IV,Random,95% CI
Mean Difference
IV,Random,95% CI
32
100.0 %
-0.72 [ -1.23, -0.21 ]
100.0 %
-0.72 [ -1.23, -0.21 ]
Heterogeneity: not applicable

Test for overall effect: Z = 2.76 (P = 0.0057)
-4
-2
Favours flouride

Favours placebo
11
Analysis 1.2. Comparison 1 Slow-release fluoride device versus placebo, Outcome 2 Increase in DMFS at 2
years compared to baseline.
Review:
Comparison: 1 Slow-release fluoride device versus placebo

Outcome: 2 Increase in DMFS at 2 years compared to baseline
Study or subgroup
Fluoride
Placebo
Mean Difference
Mean(SD)
Mean(SD)
Toumba 2005
31
0.29 (0.72)
32
1.81 (3.28)
Total (95% CI)
31
Weight
IV,Random,95% CI
Mean Difference
IV,Random,95% CI
32
100.0 %
-1.52 [ -2.68, -0.36 ]
100.0 %
-1.52 [ -2.68, -0.36 ]
Heterogeneity: not applicable

Test for overall effect: Z = 2.56 (P = 0.011)
-4
-2
Favours fluoride
Favours placebo
APPENDICES
Appendix 1. CENTRAL search strategy
#1. TOOTH DEMINERALIZATION single term (MeSH)
#2. DENTAL CARIES ACTIVITY TESTS single term (MeSH)
#3. DENTAL CARIES SUSCEPTIBILITY single term (MeSH)
#4. DENTAL ENAMEL SOLUBILITY single term (MeSH)
#5. (caries or carious or decay* or cavit*)
#6. ((slow* near releas*) and (dental or caries or fluoride))
#7. ((deminerali* or reminerali*) and (tooth or teeth or enamel or dentin* or root*))
#8. (#1 or #2 or #3 or #4 or #5 or #6 or #7)
#9. FLUORIDES single term (MeSH)
#10. fluoride*
#11. ((slow* near release*) or (slow* near dissolv*) or (copolymer next membrane) or (control* next releas*) or (delay* next action))
#12. ((#9 or #10) and #11)
#13. (#8 and #12)
#14. osteo*
#15. (#13 and (not #14))

12
WHATS NEW
Last assessed as up-to-date: 8 August 2006.
1 August 2008
Amended
Converted to new review format.
HISTORY
Protocol first published: Issue 1, 2005
Review first published: Issue 4, 2006
CONTRIBUTIONS OF AUTHORS
Literature searching was performed by Brian Bonner (BB). Potentially eligible studies were selected by BB and Lorna Dobbyn (LD)
and quality assessment was carried out by BB, LD, and Smriti Khanna (SK). In each case results were revealed and conflicts resolved
by discussion with Janc Clarkson (JC). All authors contributed to the script of the review.
DECLARATIONS OF INTEREST
None known.
SOURCES OF SUPPORT
Internal sources
Scottish Executive Chief Scientist Office, UK.
External sources
No sources of support supplied
INDEX TERMS

13
Medical Subject Headings (MeSH)

Cariostatic Agents [ administration & dosage]; Delayed-Action Preparations [administration & dosage]; Dental Caries [ prevention
& control]; Fluorides [ administration & dosage]
MeSH check words

Child; Humans

14

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Slow-release fluoride devices for the control of dental decay

Slow-release fluoride devices for the control of dental decay (Review)

Slow-release fluoride devices for the control of dental decay (Review)

Slow-release fluoride devices for the control of dental decay

Editorial group: Cochrane Oral Health Group.

PLAIN LANGUAGE SUMMARY

frice may not be sufficient to significantly reduce the dissolution

Slow-release fluoride devices for the control of dental decay (Review)

list, only glass ionomer cements meet the criterion of long-term

Criteria for considering studies for this review

(1) The changes in decayed, missing, and filled teeth or surfaces or

(1) Time taken to fit slow-release devices.

Search methods for identification of studies

the Cochrane Oral Health Groups Trials Register (to

Data collection and analysis

Selection of potentially eligible studies

Study inclusion criteria

Slow-release fluoride devices for the control of dental decay (Review)

Random-effects modelling was to be used in analyses. However,

utilised portable dental equipment set up in seven primary schools

Characteristics of the participants

Improving and updating reviews

Characteristics of the interventions

Changes in dmf (DMF)

Search results, excluded and included studies

Characteristics of the trial and settings of the

Progression of caries into enamel or dentine

Slow-release fluoride devices for the control of dental decay (Review)

result, they concluded that fluoride released from slow-dissolving

Risk of bias in included studies

Comparison of slow-release device versus placebo

Implications for research

Slow-release fluoride devices for the control of dental decay (Review)

much fluoride should be released from the devices for optimum

References to studies included in this review

References to studies excluded from this review

Slow-release fluoride devices for the control of dental decay (Review)

form on orthodontic plates. Journal of Pharmocological Science

Indicates the major publication for the study

Slow-release fluoride devices for the control of dental decay (Review)

Characteristics of included studies [ordered by study ID]

Dental caries was assessed at baseline, at 1 year, and at 2 years.

dmft = decayed, missing, and filled primary teeth

Characteristics of excluded studies [ordered by study ID]

De Los Santos 1994

RCT = randomised controlled trial

Slow-release fluoride devices for the control of dental decay (Review)

DATA AND ANALYSES

Comparison 1. Slow-release fluoride device versus placebo

Outcome or subgroup title

Mean Difference (IV, Random, 95% CI)

-0.72 [-1.23, -0.21]

Mean Difference (IV, Random, 95% CI)

-1.52 [-2.68, -0.36]

Slow-release fluoride devices for the control of dental decay

Comparison: 1 Slow-release fluoride device versus placebo

Total (95% CI)

-0.72 [ -1.23, -0.21 ]

-0.72 [ -1.23, -0.21 ]

Heterogeneity: not applicable

Slow-release fluoride devices for the control of dental decay (Review)

Slow-release fluoride devices for the control of dental decay

Comparison: 1 Slow-release fluoride device versus placebo