Abstract

The Cochrane Oral Health Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, CINAHL, LILACS and BBO, ProQuest Dissertations and Theses, Web of Science Conference Proceedings and ClinicalTrials.gov databases were searched. Reference lists of identified articles were also scanned for relevant papers. Study authors were contacted for additional information. Randomised or quasi-randomised controlled trials using or indicating blind outcome assessment that compared fluoride varnish to placebo or no treatment for at least one year were included. Risk of bias assessment was undertaken. Study assessment and data extraction was carried out independently by at least two reviewers. The primary measure of effect was the prevented fraction, that is the difference in mean caries increments between the treatment and control groups expressed as a percentage of the mean increment in the control group. The caries increments nearest to three years were used from each included study. Random-effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random-effects meta-regression analyses. Adverse effects information was collected from the included trials. Twenty-two trials (12,455 participants) were included. Thirteen trials were included in the permanent tooth surfaces meta-analysis, the pooled D(M)FS prevented fraction estimate comparing fluoride varnish with placebo or no treatment was 43% (95% confidence interval (CI) 30% to 57%; P < 0.0001). There was substantial heterogeneity, confirmed statistically (P < 0.0001; I(2) = 75%), however this body of evidence was assessed as of moderate quality. Ten trials contributed to the meta-analysis of primary teeth, the pooled d(e/m)fs prevented fraction estimate was 37% (95% CI 24% to 51%; P < 0.0001), there was some heterogeneity (P = 0.009; I(2) = 59%) this evidence was assessed as of moderate quality. No significant associations in either dentitions were found with baseline caries severity, background exposure to fluorides, application features such as prior prophylaxis, concentration of fluoride or frequency of application. There was little information concerning possible adverse effects or acceptability of treatment. The conclusions of this updated review remain the same as when it was first published. The review suggests a substantial caries inhibiting effect of fluoride varnish in both permanent and primary teeth; however the quality of the evidence was assessed as moderate, as it included mainly high risk of bias studies, with considerable heterogeneity.

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