Assessment Of Potential Adverse Effects Research Articles

A substantial caries-inhibiting effect of fluoride varnish is suggested

Question: In children under 16 is fluoride varnish effective in preventing caries? Objective To determine the effectiveness and safety of fluoride varnishes in the prevention of dental caries in children and to examine factors potentially modifying their effect.Data sources The reviewers attempted to identify all relevant studies irrespective of language, from 1965 onwards. Multiple electronic database were searched together with reference lists of articles, prospective hand searches of the journals identified as publishing the most eligible trials, and searches for selected authors and manufacturers.Study selection Randomised or quasi-randomised controlled trials were included if they had blind outcome assessment and compared fluoride varnish with placebo or no treatment in children up to 16 years old for at least 1 year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (DMFS).Data extraction and synthesis Inclusion decisions, quality assessment and data extraction were duplicated in a random sample of one third of studies, and consensus was achieved by discussion with a third party. Study authors were contacted for missing data. The primary measure of effect was the prevented fraction (PF), that is, the difference in caries increments between the treatment and control groups expressed as a proportion of the increment in the control group. Random effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random-effects meta-regression analyses.Results Nine studies were included, involving 2709 children. Seven contributed data for the main meta-analysis. There was substantial heterogeneity. The estimated pooled prevented fraction for permanent teeth was 46% (95% CI 30–63) and 33% (95% CI 19–48) for deciduous teeth. No significant association between estimates of dfs, DMFS, PF and baseline caries severity or background exposure to fluorides was found in meta-regression, and a funnel plot of the seven studies indicated no relationship between PF and study precision. In both methods, power is limited when only a few trials are included.Conclusions The review suggests a substantial caries-inhibiting effect of fluoride varnish in both the permanent and the deciduous dentitions based largely on trials that had no treatment controls. There is little information concerning acceptability of treatment or possible side-effects in the trials included. Given the relatively poor quality of most of the studies and the wide confidence intervals around the estimates of effect, there remains a need for further trials of high quality that include assessment of potential adverse effects.

Fluoride varnishes for preventing dental caries in children and adolescents.

Topically applied fluoride varnishes have been used extensively as an operator-applied caries-preventive intervention for over two decades. To determine the effectiveness and safety of fluoride varnishes in the prevention of dental caries in children and to examine factors potentially modifying their effect. Multiple electronic database searches, reference lists of articles, journal handsearch, selected authors and manufacturers. Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride varnish with placebo or no treatment in children up to 16 years during at least one year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS). Inclusion decisions, quality assessment and data extraction were duplicated in a random sample of one third of studies, and consensus achieved by discussion or a third party. Study authors were contacted for missing data. The primary measure of effect was the prevented fraction (PF), that is the difference in caries increments between the treatment and control groups expressed as a percentage of the increment in the control group. Random effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random effects meta-regression analyses. Nine studies were included, involving 2709 children. For the seven that contributed data for the main meta-analysis, the D(M)FS pooled prevented fraction estimate was 46% (95% CI, 30% to 63%; p<0.0001). There was substantial heterogeneity, confirmed statistically (p<0.0001). The pooled d(e/m)fs prevented fraction estimate was 33% (95% CI, 19% to 48%; p<0.0001). No significant association between estimates of D(M)FS prevented fractions and baseline caries severity or background exposure to fluorides was found in meta-regression, and a funnel plot of the seven studies indicated no relationship between prevented fraction and study precision. In both methods, power is limited when only a few trials are included. The review suggests a substantial caries-inhibiting effect of fluoride varnish in both the permanent and the deciduous dentitions based largely on trials with no treatment controls. There is little information concerning acceptability of treatment or possible side effects in the included trials. Given the relatively poor quality of most of the included studies and the wide confidence intervals around the estimates of effect, there remains a need for further trials. It is important that these trials should be of high quality and include assessment of potential adverse effects.

Fluoride gels for preventing dental caries in children and adolescents.

Topically applied fluoride gels have been widely used as a caries-preventive intervention in dental surgeries and school-based programs for over two decades. To determine the effectiveness and safety of fluoride gels in the prevention of dental caries in children and to examine factors potentially modifying their effect. Multiple electronic database searches, reference lists of articles, journal handsearch, selected authors and manufacturers. Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride gel with placebo or no treatment in children up to 16 years during at least one year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS). Inclusion decisions, quality assessment and data extraction were duplicated in a random sample of one third of studies, and consensus achieved by discussion or a third party. Study authors were contacted for missing data. The primary outcome measure was the prevented fraction (PF), that is the caries increment in the treatment group expressed as a percentage of the control group. Random effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random effects meta-regression analyses. Twenty-five studies were included, involving 7747 children. For the 23 that contributed data for meta-analysis, the D(M)FS pooled prevented fraction estimate was 28% (95% CI, 19% to 37%; p<0.0001). There was clear heterogeneity, confirmed statistically (p<0.0001). The effect of fluoride gel varied according to type of control group used, with D(M)FS PF on average being 19% (95% CI, 5% to 33%; p<0.009) higher in non-placebo controlled trials. A funnel plot of the 23 studies indicated a relationship between prevented fraction and study precision. Only two trials reported on adverse events. There is clear evidence of a caries-inhibiting effect of fluoride gel. The best estimate of the magnitude of this effect, based on the 14 placebo-controlled trials, is a 21% reduction (95% CI, 14 to 28%) in D(M)FS. This corresponds to an NNT of 2 (95% CI, 1 to 3) to avoid 1 D(M)FS in a population with a caries increment of 2.2 D(M)FS/year, or an NNT of 24 (95% CI, 18 to 36) based on an increment of 0.2 D(M)FS/year. There is little information concerning deciduous dentition, on adverse effects or on acceptability of treatment. Future trials should include assessment of potential adverse effects.