Fluoride mouthrinses for preventing dental caries in children and adolescents.

BACKGROUND: Fluoride mouthrinses have been used extensively as a caries-preventive intervention in school-based programmes and by individuals at home. This is an update of the Cochrane review of fluoride mouthrinses for preventing dental caries in children and adolescents that was first published in 2003. OBJECTIVES: The primary objective is to determine the effectiveness and safety of fluoride mouthrinses in preventing dental caries in the child and adolescent population.The secondary objective is to examine whether the effect of fluoride rinses is influenced by:• initial level of caries severity;• background exposure to fluoride in water (or salt), toothpastes or reported fluoride sources other than the study option(s); or• fluoride concentration (ppm F) or frequency of use (times per year). SEARCH METHODS: We searched the following electronic databases: Cochrane Oral Health's Trials Register (whole database, to 22 April 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2016, Issue 3), MEDLINE Ovid (1946 to 22 April 2016), Embase Ovid (1980 to 22 April 2016), CINAHL EBSCO (the Cumulative Index to Nursing and Allied Health Literature, 1937 to 22 April 2016), LILACS BIREME (Latin American and Caribbean Health Science Information Database, 1982 to 22 April 2016), BBO BIREME (Bibliografia Brasileira de Odontologia; from 1986 to 22 April 2016), Proquest Dissertations and Theses (1861 to 22 April 2016) and Web of Science Conference Proceedings (1990 to 22 April 2016). We undertook a search for ongoing trials on the US National Institutes of Health Trials Register (http://clinicaltrials.gov) and the World Health Organization International Clinical Trials Registry Platform. We placed no restrictions on language or date of publication when searching electronic databases. We also searched reference lists of articles and contacted selected authors and manufacturers. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials where blind outcome assessment was stated or indicated, comparing fluoride mouthrinse with placebo or no treatment in children up to 16 years of age. Study duration had to be at least one year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces in permanent teeth (D(M)FS). DATA COLLECTION AND ANALYSIS: At least two review authors independently performed study selection, data extraction and risk of bias assessment. We contacted study authors for additional information when required. The primary measure of effect was the prevented fraction (PF), that is, the difference in mean caries increments between treatment and control groups expressed as a percentage of the mean increment in the control group. We conducted random-effects meta-analyses where data could be pooled. We examined potential sources of heterogeneity in random-effects metaregression analyses. We collected adverse effects information from the included trials. MAIN RESULTS: In this review, we included 37 trials involving 15,813 children and adolescents. All trials tested supervised use of fluoride mouthrinse in schools, with two studies also including home use. Almost all children received a fluoride rinse formulated with sodium fluoride (NaF), mostly on either a daily or weekly/fortnightly basis and at two main strengths, 230 or 900 ppm F, respectively. Most studies (28) were at high risk of bias, and nine were at unclear risk of bias.From the 35 trials (15,305 participants) that contributed data on permanent tooth surface for meta-analysis, the D(M)FS pooled PF was 27% (95% confidence interval (CI), 23% to 30%; I(2) = 42%) (moderate quality evidence). We found no significant association between estimates of D(M)FS prevented fractions and baseline caries severity, background exposure to fluorides, rinsing frequency or fluoride concentration in metaregression analyses. A funnel plot of the 35 studies in the D(M)FS PF meta-analysis indicated no relationship between prevented fraction and study precision (no evidence of reporting bias). The pooled estimate of D(M)FT PF was 23% (95% CI, 18% to 29%; I² = 54%), from the 13 trials that contributed data for the permanent teeth meta-analysis (moderate quality evidence).We found limited information concerning possible adverse effects or acceptability of the treatment regimen in the included trials. Three trials incompletely reported data on tooth staining, and one trial incompletely reported information on mucosal irritation/allergic reaction. None of the trials reported on acute adverse symptoms during treatment. AUTHORS' CONCLUSIONS: This review found that supervised regular use of fluoride mouthrinse by children and adolescents is associated with a large reduction in caries increment in permanent teeth. We are moderately certain of the size of the effect. Most of the evidence evaluated use of fluoride mouthrinse supervised in a school setting, but the findings may be applicable to children in other settings with supervised or unsupervised rinsing, although the size of the caries-preventive effect is less clear. Any future research on fluoride mouthrinses should focus on head-to-head comparisons between different fluoride rinse features or fluoride rinses against other preventive strategies, and should evaluate adverse effects and acceptability.

Fluoride gels for preventing dental caries in children and adolescents.

BACKGROUND: Topically applied fluoride gels have been widely used as a caries-preventive intervention in dental surgeries and school-based programmes for over three decades. This updates the Cochrane review of fluoride gels for preventing dental caries in children and adolescents that was first published in 2002. OBJECTIVES: The primary objective is to determine the effectiveness and safety of fluoride gels in preventing dental caries in the child and adolescent population.The secondary objectives are to examine whether the effect of fluoride gels is influenced by the following: initial level of caries severity; background exposure to fluoride in water (or salt), toothpastes, or reported fluoride sources other than the study option(s); mode of use (self applied under supervision or operator-applied), and whether there is a differential effect between the tray and toothbrush methods of application; frequency of use (times per year) or fluoride concentration (ppm F). SEARCH METHODS: We searched the Cochrane Oral Health Group Trials Register (to 5 November 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library 2014, Issue 11), MEDLINE via OVID (1946 to 5 November 2014), EMBASE via OVID (1980 to 5 November 2014), CINAHL via EBSCO (1980 to 5 November 2014), LILACS and BBO via the BIREME Virtual Health Library (1980 to 5 November 2014), ProQuest Dissertations and Theses (1861 to 5 November 2014) and Web of Science Conference Proceedings (1945 to 5 November 2014). We undertook a search for ongoing trials on ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform on 5 November 2014. We placed no restrictions on language or date of publication in the search of the electronic databases. We also searched reference lists of articles and contacted selected authors and manufacturers. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials where blind outcome assessment was stated or indicated, comparing topically applied fluoride gel with placebo or no treatment in children up to 16 years. The frequency of application had to be at least once a year, and study duration at least one year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces in both permanent and primary teeth (D(M)FS and d(e/m)fs). DATA COLLECTION AND ANALYSIS: At least two review authors independently performed study selection, data extraction and 'Risk of bias' assessment. We contacted study authors for additional information where required. The primary measure of effect was the prevented fraction (PF), 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. We performed random-effects meta-analyses where we could pool data. We examined potential sources of heterogeneity in random-effects metaregression analyses. We collected adverse effects information from the included trials. MAIN RESULTS: We included 28 trials (3 of which are new trials since the original review), involving 9140 children and adolescents. Most of these trials recruited participants from schools. Most of the studies (20) were at high risk of bias, with 8 at unclear risk of bias.Twenty-five trials (8479 participants) contributed data for meta-analysis on permanent tooth surfaces: the D(M)FS pooled prevented fraction (PF) estimate was 28% (95% confidence intervals (CI) 19% to 36%; P < 0.0001; with substantial heterogeneity (P < 0.0001; I(2) = 82%); moderate quality evidence). Subgroup and metaregression analyses suggested no significant association between estimates of D(M)FS prevented fractions and the prespecified trial characteristics. However, the effect of fluoride gel varied according to the type of control group used, with D(M)FS PF on average being 17% (95% CI 3% to 31%; P = 0.018) higher in non-placebo-controlled trials (the reduction in caries was 38% (95% CI 24% to 52%; P < 0.0001, 2808 participants) for the 10 trials with no treatment as control group, and 21% (95% CI 15% to 28%; P < 0.0001, 5671 participants) for the 15 placebo-controlled trials. A funnel plot of the 25 trials in the D(M)FS PF meta-analysis indicated a relationship between prevented fraction and study precision, with an apparent lack of small studies with statistically significant large effects.The d(e/m)fs pooled prevented fraction estimate for the three trials (1254 participants) that contributed data for the meta-analysis on primary teeth surfaces was 20% (95% CI 1% to 38%; P = 0.04; with no heterogeneity (P = 0.54; I(2) = 0%); low quality evidence).There was limited reporting of adverse events. Only two trials reported information on acute toxicity signs and symptoms during the application of the gel (risk difference 0.01, 95% CI -0.01 to 0.02; P = 0.36; with no heterogeneity (P = 36; I(2) = 0%); 490 participants; very low quality evidence). None of the trials reported information on tooth staining, mucosal irritation or allergic reaction. AUTHORS' CONCLUSIONS: The conclusions of this updated review remain the same as those when it was first published. There is moderate quality evidence of a large caries-inhibiting effect of fluoride gel in the permanent dentition. Information concerning the caries-preventive effect of fluoride gel on the primary dentition, which also shows a large effect, is based on low quality evidence from only three placebo-controlled trials. There is little information on adverse effects or on acceptability of treatment. Future trials should include assessment of potential adverse effects.

Mandibular advancement splint (MAS) therapy for obstructive sleep apnoea--an overview and quality assessment of systematic reviews.

BACKGROUND: To conduct an overview of existing systematic reviews concerning management of obstructive sleep apnoea-hypopnoea syndrome (OSAHS) with mandibular advancement splint (MAS) and assess their methodological quality. METHOD: PubMed and relevant Cochrane Library databases (CDSR, DARE, HTA) searches were performed (09.13) to identify systematic reviews investigating the response of adults with OSAHS to MAS therapy. The methodological quality of the included systematic reviews was assessed using AMSTAR, a validated tool for assessing quality. RESULTS: Eight systematic reviews, four incorporating meta-analyses, were identified evaluating both objective and subjective outcome measures. The effectiveness of MAS therapy was compared to no treatment (n = 1), non-active appliance (n = 6), continuous positive airway pressure (CPAP; n = 5), surgical intervention (n = 3) and a different MAS intervention (n = 4). The quality of the reviews was variable (median = 7, range = 3 to 11), with only two of higher quality (AMSTAR scores >10), one of them a Cochrane review. In this high quality and current review, the overall (pooled) effects for comparison of MAS therapy with inactive appliances, revealed significant benefits of MAS therapy in terms of both daytime sleepiness and objective apnoea-hypopnoea index (AHI) outcomes. CONCLUSION: In general, the results from the higher quality reviews concerning the effectiveness of MAS therapy for OSAHS highlight the ability of the intervention to improve OSAHS. Current reporting guidelines for systematic reviews (e.g. PRISMA) and sources of high-quality existing reviews should be closely followed to enhance the validity and relevance of future reviews.

Maternal Smokeless Tobacco Use in Pregnancy and Adverse Health Outcomes in Newborns: A Systematic Review.

BACKGROUND: Perinatal morbidity and mortality are important indicators of maternal health and the future health of the child. Smokeless tobacco (ST) use during pregnancy is associated with low birth weight (LBW), preterm births, stillbirths, and small for gestation age (SGA). This study systematically reviews and summarizes evidence on the association of maternal ST use with these adverse health outcomes in newborns. METHODS: Electronic databases (Medline, Embase, Lilacs) were searched in July 2013 using appropriate keywords complemented with reference list searching. Observational studies of maternal ST use and these outcomes were considered; LBW, preterm, stillbirth, SGA. A comprehensive assessment of quality and risk of bias in all included studies was performed. RevMan software was used for data analysis. Results are expressed as crude odds ratios with 95% confidence intervals. Chi-square and I(2) tests checked for heterogeneity and quantified inconsistency between results. RESULTS: There were 9 studies (16 reports) included (7 cohort-studies, 1 case-control study, and 1 cross-sectional study). They were clinically and methodologically diverse. Significant associations with ST use were seen in 5/7 studies for LBW, in 3/6 studies for preterm, in all 4 studies for stillbirth and in 1/2 studies assessing SGA. Heterogeneity between results was moderate for LBW (I(2) = 44%) and stillbirth (I(2) = 52%), and high for preterm (I(2) = 87%) and SGA (I(2) = 65%). Meta-analysis was considered inappropriate due to risk of bias and confounding. CONCLUSIONS: Although most studies show an association between ST use in pregnancy and adverse health effects in newborns, these results may be limited by confounding and bias. Quality observational studies are needed to strengthen this evidence base.

Fluoride varnishes for preventing dental caries in children and adolescents.

BACKGROUND: Topically-applied fluoride varnishes have been used extensively as an operator-applied caries-preventive intervention for over three decades. This review updates the first Cochrane review of fluoride varnishes for preventing dental caries in children and adolescents, which was first published in 2002. OBJECTIVES: To determine the effectiveness and safety of fluoride varnishes in preventing dental caries in children and adolescents, and to examine factors potentially modifying their effect. SEARCH METHODS: We searched the Cochrane Oral Health Group's Trials Register (to 13 May 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 4), MEDLINE via OVID (1946 to 13 May 2013), EMBASE via OVID (1980 to 13 May 2013), CINAHL via EBSCO (1980 to 13 May 2013), LILACS and BBO via the BIREME Virtual Health Library (1980 to 13 May 2013), ProQuest Dissertations and Theses (1861 to 13 May 2013), and Web of Science Conference Proceedings (1945 to 13 May 2013). A search for ongoing trials was undertaken on ClinicalTrials.gov on 13 May 2013. There were no restrictions on language or date of publication in the search of the electronic databases. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials with blind outcome assessment used or indicated, comparing topically-applied 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 in both permanent (D(M)FS) and primary (d(e/m)fs) teeth. DATA COLLECTION AND ANALYSIS: At least two review authors assessed all search results, extracted data and undertook risk of bias independently. Study authors were contacted for additional information. 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. MAIN RESULTS: Twenty-two trials with 12,455 participants randomised (9595 used in analyses) were included. For the 13 that contributed data for 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. The pooled d(e/m)fs prevented fraction estimate was 37% (95% CI 24% to 51%; P < 0.0001) for the 10 trials that contributed data for the primary tooth surfaces meta-analysis, also with some heterogeneity (P = 0.009; I(2) = 59%). Once again this body of evidence was assessed as of moderate quality. No significant association between estimates of D(M)FS or d(e/m)fs prevented fractions and the pre-specified factors of baseline caries severity, background exposure to fluorides, application features such as prior prophylaxis, concentration of fluoride, frequency of application were found. There was also no significant association between estimates of D(M)FS or d(e/m)fs prevented fractions and the post hoc factors: whether a placebo or no treatment control was used, length of follow-up, or whether individual or cluster randomisation was used, in the meta-regression models. A funnel plot of the trials in the main meta-analyses indicated no clear relationship between prevented fraction and study precision. In both methods, power is limited when few trials are included. There was little information concerning possible adverse effects or acceptability of treatment. AUTHORS' CONCLUSIONS: The conclusions of this updated review remain the same as those 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.

Systematic review of controlled trials on the effectiveness of fluoride gels for the prevention of dental caries in children.

Fluoride gels have been widely used since the 1970s. The aim of this review was to assess the effectiveness and safety of fluoride gels in the prevention of dental caries in children and to examine factors potentially modifying their effectiveness. Relevant randomized or quasi-randomized trials were identified without language restrictions by searching multiple databases, reference lists of articles, and journals and by contacting selected authors and manufacturers. Trials with blind outcome assessment comparing fluoride gel with placebo or no treatment for at least one year and involving children under seventeen years of age were selected. Inclusion decisions, quality assessment, and data extraction were duplicated in a random sample of one third of studies, and consensus was achieved by discussion or a third party. Random effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random effects meta-regression analyses. The main outcome was caries increment measured by the change in decayed, missing, and filled permanent tooth surfaces (D(M)FS). The primary measure of effect was the prevented fraction (PF) that is the difference in mean caries increment between the treatment and control groups expressed as a percentage of the mean increment in the control group. Potential adverse effects and unacceptability of treatment were also recorded. Twenty-five studies were included, involving 7,747 children. For the twenty-three that contributed data for meta-analysis, the D(M)FS pooled prevented fraction estimate was 28 percent (95 percent CI, 19 percent to 37 percent; 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 percent (95 percent CI, 5 percent to 33 percent; p < 0.009) higher in non-placebo controlled trials. 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 fourteen placebo-controlled trials, is a 21 percent reduction (95 percent CI, 14 to 28 percent) in D(M)FS. This corresponds to an NNT of two (95 percent CI, 1 to 3) to avoid one D(M)FS in a population with a caries increment of 2.2 D(M)FS/year, or an NNT of twenty-four (95 percent CI, 18 to 36) based on an increment of 0.2 D(M)FS/year. However, further work is needed to identify and quantify potential harmful effects of fluoride gels.