Slow-release fluoride devices for the control of dental decay.
Author(s): Chong LY(1), Clarkson JE, Dobbyn-Ross L, Bhakta S.
Affiliation(s): Author information:
(1)UK Cochrane Centre, Oxford, UK.
Publication date & source: 2014, Cochrane Database Syst Rev. , 11:CD005101
BACKGROUND: Slow-release fluoride devices have been investigated as a potentially
cost-effective method of reducing dental caries in people with high risk of
disease.
OBJECTIVES: To evaluate the effectiveness and safety of different types of
slow-release fluoride devices on preventing, arresting, or reversing the
progression of carious lesions on all surface types of primary (deciduous) and
permanent teeth.
SEARCH METHODS: We searched the following electronic databases: the Cochrane Oral
Health Group Trials Register (to 13 August 2014), the Cochrane Central Register
of Controlled Trials (CENTRAL) (2014, Issue 7), MEDLINE via Ovid (1946 to 13
August 2014), and EMBASE via Ovid (1980 to 13 August 2014). We searched the US
National Institutes of Health Trials Register and the World Health Organization
(WHO) International Clinical Trials Registry Platform. We placed no restrictions
on the language or date of publication when searching the electronic databases.We
first published the review in 2006. The update in 2013 found 302 abstracts, but
none of these met the inclusion criteria of the review.
SELECTION CRITERIA: Parallel 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: We conducted data collection and analysis using
standard Cochrane review methods. At least two review authors independently
performed all the key steps in the review such as screening of abstracts,
application of inclusion criteria, data extraction, and risk of bias assessment.
We resolved discrepancies through discussions or arbitration by a third or fourth
review author.
MAIN RESULTS: We found no evidence comparing slow-release fluoride devices
against other types of fluoride therapy.We found only one double-blind RCT
involving 174 children comparing a slow-release fluoride device (glass beads with
fluoride were attached to buccal surfaces of right maxillary first permanent
molar teeth) against control (glass beads without fluoride were attached to
buccal surfaces of right maxillary first permanent molar teeth). This study was
assessed to be at high risk of bias. The study recruited children from seven
schools in an area of deprivation that had low levels of fluoride in the water.
The mean age at the beginning of the study was 8.8 years and at the termination
was 10.9 years. DMFT in permanent teeth or dmft in primary teeth was greater than
one at the start of the study and greater than one million colony-forming units
of Streptococcus mutans per millilitre of saliva.Although 132 children were still
included in the trial at the two-year completion point, examination and
statistical analysis was performed on only the 63 children (31 in intervention
group, 32 in control group) who had retained the beads (retention rate was 47.7%
at two years). Among these 63 children, caries increment was reported to be
statistically significantly lower in the intervention group than in the control
group (DMFT: mean difference -0.72, 95% confidence interval (CI) -1.23 to -0.21;
DMFS: mean difference -1.52, 95% CI -2.68 to -0.36 (very low quality evidence)).
Although this difference was clinically significant, it only holds true for those
children who maintain the fluoride beads; over 50% of children did not retain the
beads.Harms were not reported within the trial report. Evidence for other
outcomes sought in this review (progression to of caries lesion, dental pain,
healthcare utilisation data) were also not reported.
AUTHORS' CONCLUSIONS: There is insufficeint evidence to determine the
caries-inhibiting effect of slow-release fluoride glass beads. The body of
evidence available is of very low quality and there is a potential overestimation
of benefit to the average child. The applicability of the findings to the wider
population is unclear; the study had included children from a deprived area that
had low levels of fluoride in drinking water, and were considered at high risk of
carries. In addition, the evidence was only obtained from children who still had
the bead attached at two years (48% of all available children); children who had
lost their slow-release fluoride devices earlier might not have benefited as much
from the devices.
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