Fluoride toothpastes of different concentrations for preventing dental caries.

BACKGROUND: Caries (dental decay) is a disease of the hard tissues of the teeth caused by an imbalance, over time, in the interactions between cariogenic bacteria in dental plaque and fermentable carbohydrates (mainly sugars). Regular toothbrushing with fluoride toothpaste is the principal non-professional intervention to prevent caries, but the caries-preventive effect varies according to different concentrations of fluoride in toothpaste, with higher concentrations associated with increased caries control. Toothpastes with higher fluoride concentration increases the risk of fluorosis (enamel defects) in developing teeth. This is an update of the Cochrane Review first published in 2010. OBJECTIVES: To determine and compare the effects of toothpastes of different fluoride concentrations (parts per million (ppm)) in preventing dental caries in children, adolescents, and adults. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 15 August 2018); the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 7) in the Cochrane Library (searched 15 August 2018); MEDLINE Ovid (1946 to 15 August 2018); and Embase Ovid (1980 to 15 August 2018). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials (15 August 2018). No restrictions were placed on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: Randomised controlled trials that compared toothbrushing with fluoride toothpaste with toothbrushing with a non-fluoride toothpaste or toothpaste of a different fluoride concentration, with a follow-up period of at least 1 year. The primary outcome was caries increment measured by the change from baseline in the decayed, (missing), and filled surfaces or teeth index in all permanent or primary teeth (D(M)FS/T or d(m)fs/t). DATA COLLECTION AND ANALYSIS: Two members of the review team, independently and in duplicate, undertook the selection of studies, data extraction, and risk of bias assessment. We graded the certainty of the evidence through discussion and consensus. The primary effect measure was the mean difference (MD) or standardised mean difference (SMD) caries increment. Where it was appropriate to pool data, we used random-effects pairwise or network meta-analysis. MAIN RESULTS: We included 96 studies published between 1955 and 2014 in this updated review. Seven studies with 11,356 randomised participants (7047 evaluated) reported the effects of fluoride toothpaste up to 1500 ppm on the primary dentition; one study with 2500 randomised participants (2008 evaluated) reported the effects of 1450 ppm fluoride toothpaste on the primary and permanent dentition; 85 studies with 48,804 randomised participants (40,066 evaluated) reported the effects of toothpaste up to 2400 ppm on the immature permanent dentition; and three studies with 2675 randomised participants (2162 evaluated) reported the effects of up to 1100 ppm fluoride toothpaste on the mature permanent dentition. Follow-up in most studies was 36 months.In the primary dentition of young children, 1500 ppm fluoride toothpaste reduces caries increment when compared with non-fluoride toothpaste (MD -1.86 dfs, 95% confidence interval (CI) -2.51 to -1.21; 998 participants, one study, moderate-certainty evidence); the caries-preventive effects for the head-to-head comparison of 1055 ppm versus 550 ppm fluoride toothpaste are similar (MD -0.05, dmfs, 95% CI -0.38 to 0.28; 1958 participants, two studies, moderate-certainty evidence), but toothbrushing with 1450 ppm fluoride toothpaste slightly reduces decayed, missing, filled teeth (dmft) increment when compared with 440 ppm fluoride toothpaste (MD -0.34, dmft, 95%CI -0.59 to -0.09; 2362 participants, one study, moderate-certainty evidence). The certainty of the remaining evidence for this comparison was judged to be low.We included 81 studies in the network meta-analysis of D(M)FS increment in the permanent dentition of children and adolescents. The network included 21 different comparisons of seven fluoride concentrations. The certainty of the evidence was judged to be low with the following exceptions: there was high- and moderate-certainty evidence that 1000 to 1250 ppm or 1450 to 1500 ppm fluoride toothpaste reduces caries increments when compared with non-fluoride toothpaste (SMD -0.28, 95% CI -0.32 to -0.25, 55 studies; and SMD -0.36, 95% CI -0.43 to -0.29, four studies); there was moderate-certainty evidence that 1450 to 1500 ppm fluoride toothpaste slightly reduces caries increments when compared to 1000 to 1250 ppm (SMD -0.08, 95% CI -0.14 to -0.01, 10 studies); and moderate-certainty evidence that the caries increments are similar for 1700 to 2200 ppm and 2400 to 2800 ppm fluoride toothpaste when compared to 1450 to 1500 ppm (SMD 0.04, 95% CI -0.07 to 0.15, indirect evidence only; SMD -0.05, 95% CI -0.14 to 0.05, two studies).In the adult permanent dentition, 1000 or 1100 ppm fluoride toothpaste reduces DMFS increment when compared with non-fluoride toothpaste in adults of all ages (MD -0.53, 95% CI -1.02 to -0.04; 2162 participants, three studies, moderate-certainty evidence). The evidence for DMFT was low certainty.Only a minority of studies assessed adverse effects of toothpaste. When reported, effects such as soft tissue damage and tooth staining were minimal. AUTHORS' CONCLUSIONS: This Cochrane Review supports the benefits of using fluoride toothpaste in preventing caries when compared to non-fluoride toothpaste. Evidence for the effects of different fluoride concentrations is more limited, but a dose-response effect was observed for D(M)FS in children and adolescents. For many comparisons of different concentrations the caries-preventive effects and our confidence in these effect estimates are uncertain and could be challenged by further research. The choice of fluoride toothpaste concentration for young children should be balanced against the risk of fluorosis.

Graphs of study contributions and covariate distributions for network meta-regression.

BACKGROUND: Meta-regression results must be interpreted taking into account the range of covariate values of the contributing studies. Results based on interpolation or extrapolation may be unreliable. In network meta-regression (NMR) models, which include covariates in network meta-analyses, results are estimated using direct and indirect evidence; therefore, it may be unclear which studies and covariate values contribute to which result. We propose graphs to help understand which trials and covariate values contribute to each NMR result and to highlight extrapolation or interpolation. METHODS: We introduce methods to calculate the contribution that each trial and covariate value makes to each result and compare them with existing methods. We show how to construct graphs including a network covariate distribution diagram, covariate-contribution plot, heat plot, contribution-NMR plot, and heat-NMR plot. We demonstrate the methods using a dataset with treatments for malaria using the covariate average age and a dataset of topical fluoride interventions for preventing dental caries using the covariate randomisation year. RESULTS: For the malaria dataset, no contributing trials had an average age between 7-25 years and therefore results were interpolated within this range. For the fluoride dataset, there are no contributing trials randomised between 1954-1959 for most comparisons therefore, within this range, results would be extrapolated. CONCLUSIONS: Even in a fully connected network, an NMR result may be estimated from trials with a narrower covariate range than the range of the whole dataset. Calculating contributions and graphically displaying them aids interpretation of NMR result by highlighting extrapolated or interpolated results.

Atraumatic restorative treatment versus conventional restorative treatment for managing dental caries.

BACKGROUND: Dental caries is a sugar-dependent disease that damages tooth structure and, due to loss of mineral components, may eventually lead to cavitation. Dental caries is the most prevalent disease worldwide and is considered the most important burden of oral health. Conventional treatment methods (drill and fill) involve the use of rotary burs under local anaesthesia. The need for an electricity supply, expensive handpieces and highly trained dental health personnel may limit access to dental treatment, especially in underdeveloped regions.To overcome the limitations of conventional restorative treatment, the Atraumatic Restorative Treatment (ART) was developed, mainly for treating caries in children living in under-served areas of the world where resources and facilities such as electricity and trained manpower are limited. ART is a minimally invasive approach which involves removal of decayed tissue using hand instruments alone, usually without use of anaesthesia and electrically driven equipment, and restoration of the dental cavity with an adhesive material (glass ionomer cement (GIC), composite resins, resin-modified glass-ionomer cement (RM-GICs) and compomers). OBJECTIVES: To assess the effects of Atraumatic Restorative Treatment (ART) compared with conventional treatment for managing dental caries lesions in the primary and permanent teeth of children and adults. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 22 February 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 1), MEDLINE Ovid (1946 to 22 February 2017), Embase Ovid (1980 to 22 February 2017), LILACS BIREME Virtual Health Library (Latin American and Caribbean Health Science Information database; 1982 to 22 February 2017) and BBO BIREME Virtual Health Library (Bibliografia Brasileira de Odontologia; 1986 to 22 February 2017). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: We included randomised controlled trials (RCTs) with at least six months' follow-up that compared the effects of ART with a conventional restorative approach using the same or different restorative dental materials to treat caries lesions. DATA COLLECTION AND ANALYSIS: Two review authors independently screened search results, extracted data from included studies and assessed the risk of bias in those studies. We used standard methodological procedures expected by Cochrane to evaluate risk of bias and synthesise data. Where pooling was appropriate we conducted meta-analyses using the random-effects model. We assessed the quality of the evidence using GRADE criteria. MAIN RESULTS: We included a total of 15 eligible studies randomising 3760 participants in this review. The age of participants across the studies ranged from 3 to 101 years, with a mean of 25.42 years. 48% of participants were male. All included studies were published between 2002 and 2016. Two of the 15 studies declared that the financial support was from companies that manufacture restorative material. Five studies were individually randomised parallel-group studies; six were cluster-randomised parallel-group studies; and four were randomised studies that used a split-mouth design. Eleven studies evaluated the effects of ART on primary teeth only, and four on permanent teeth. The follow-up period of the included studies ranged from 6 months to 36 months. We judged all studies to be at high risk of bias.For the main comparison of ART compared to conventional treatment using the same material: all but two studies used high-viscosity glass ionomer (H-GIC) as the restorative material; one study used a composite material; and one study used resin-modified glass ionomer cement (RM-GIC)).Compared to conventional treatment using H-GIC, ART may increase the risk of restoration failure in the primary dentition, over a follow-up period from 12 to 24 months (OR 1.60, 95% CI 1.13 to 2.27, five studies; 643 participants analysed; low-quality evidence). Our confidence in this effect estimate is limited due to serious concerns over risk of performance and attrition bias. For this comparison, ART may reduce pain during procedure compared with conventional treatment (MD -0.65, 95% CI -1.38 to 0.07; 40 participants analysed; low-quality evidence)Comparisons of ART to conventional treatment using composite or RM-GIC were downgraded to very low quality due to indirectness, imprecision and high risk of performance and attrition bias. Given the very low quality of the evidence from single studies, we are uncertain about the restoration failure of ART compared with conventional treatment using composite over a 24-month follow-up period (OR 1.11, 95% CI 0.54 to 2.29; one study; 57 participants) and ART using RM-GIC in the permanent teeth of older adults with root caries lesions over a six-month follow-up period (OR 2.71, 95% CI 0.94 to 7.81; one study; 64 participants).No studies reported on adverse events or costs. AUTHORS' CONCLUSIONS: Low-quality evidence suggests that ART using H-GIC may have a higher risk of restoration failure than conventional treatment for caries lesions in primary teeth. The effects of ART using composite and RM-GIC are uncertain due to the very low quality of the evidence and we cannot rely on the findings. Most studies evaluated the effects of ART on the primary dentition.Well-designed RCTs are required that report on restoration failure at clinically meaningful time points, as well as participant-reported outcomes such as pain and discomfort. Due to the potential confounding effects from the use of different dental materials, a robust body of evidence on the effects of ART compared with conventional treatment using the same restoration material is necessary. We identified four ongoing trials that could provide further insights into this area.

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.

Comparison of maxillary arch dimensional changes with passive and active self-ligation and conventional brackets in the permanent dentition: a multicenter, randomized controlled trial.

INTRODUCTION: The purpose of this study was to compare maxillary arch dimensional and inclination changes during alignment with conventional brackets and self-ligation. METHODS: Ninety-six patients, ages 16 years and above, were included in this multicenter, 3-group parallel randomized trial. The main outcome measures were changes in maxillary intercanine, interpremolar, and intermolar dimensions, and molar and incisor inclination changes. The patients were randomly allocated in permuted blocks of 12 subjects into 3 equal groups with the allocations concealed in opaque sealed envelopes. Each participant underwent alignment with a standard Damon Q (Ormco, Orange, Calif) wire sequence for a minimum of 34 weeks. Blinding of clinicians and patients was not possible. Data were analyzed on a per-protocol basis, since losses to follow-up were minimal. RESULTS: Complete data were obtained from 87 subjects. Bracket type had no significant effect on any of the transverse dimensional changes. No difference in molar inclination was found between passive self-ligation and conventional brackets (0.67°; 95% CI, -2.24, 3.58; P = 0.65) or active self-ligation (0.91°; 95% CI, -1.95, 3.78; P = 0.53). Similarly, incisor inclination changes with the Damon Q could not be differentiated from those developing with either conventional system (0.44°; 95% CI, -1.93, 2.8; P = 0.71) or In-Ovation C (-0.22°; 95% CI, -2.58, 2.14; P = 0.85). No harms were encountered. CONCLUSIONS: No difference in the arch dimensional or inclination changes during alignment can be expected between conventional brackets and either active or passive self-ligation.

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.

Socioeconomic status and self-reported oral health in Iranian adolescents: the role of selected oral health behaviors and psychological factors.

OBJECTIVES: This study investigated health inequality for self-reported oral health outcomes among adolescents. The role of oral health behaviors and psychological factors in explaining oral health inequality was investigated using the hypothesis of mediation. METHODS: This was a cross-sectional study that used self-completed questionnaires. This study sampled 639 (315 male and 324 female) 15- to 17-year-old adolescents (second and third grade high school students) of both sexes in the city of Sanandaj in the province of Kurdistan, western Iran. Socioeconomic indicators of the study were subjective socioeconomic status, wealth index, and parental education. Oral health behaviors were measured as toothbrushing frequency, dental flossing frequency, and dental visits. Psychological factors were self-esteem, anxiety, and depression. Self-reported oral health outcomes were single item self-rated oral health and the experience of dental pain. Regression analysis was used to test four conditions for the hypothesis of mediation. RESULTS: The results showed that the inequality is present in oral health for some pairs of relationships between socioeconomic status and oral health outcomes. Adjustment for oral health behaviors and psychological factors, individually and simultaneously, led to loss of statistical significance for some pairs of the relationships. However, adjustment for oral health behaviors and psychological factors led to only small changes in the associations between socioeconomic status and self-reported oral health outcomes. CONCLUSIONS: This study found a graded oral health inequality, but no strong evidence to support the hypothesis that oral health behaviors and psychological factors mediate oral health inequality for self-reported oral health outcomes.

Quality of cluster randomized controlled trials in oral health: a systematic review of reports published between 2005 and 2009.

OBJECTIVES: To assess the quality of methods and reporting of recently published cluster randomized trials (CRTs) in oral health. METHODS: We searched PubMed for CRTs that included at least one oral health-related outcome and were published from 2005 to 2009 inclusive. We developed a list of criteria for assessing trial quality and reporting. This was influenced largely by the extended CONSORT statement for CRTs but also included criteria suggested by other authors. We examined the extent to which trials were consistent with these criteria. RESULTS: Twenty-three trials were included in the review. In 15 (65%) trials, clustering had been accounted for in sample size calculations, and in 18 (78%) authors had accounted for clustering in analysis. Intraclass correlation coefficients (ICCs) were reported for eight (35%) trials; the outcome assessor was reported as having been blinded to allocation in 12 (52%) trials; 17 (74%) described eligibility criteria at individual level, but only nine (39%) described such criteria at cluster level. Sixteen of 20 trials (80%), in which individuals were recruited, reported that individual informed consent was obtained. CONCLUSIONS: These results suggest that the quality of recent CRTs in oral health is relatively high and appears to compare favourably with other fields. However, there remains room for improvement. Authors of future trials should endeavour to ensure sample size calculations and analyses properly account for clustering (and are reported as such), consider the potential for recruitment/identification bias at the design stage, describe the steps taken to avoid this in the final report and report observed ICCs and cluster-level eligibility criteria.

Topical fluoride as a cause of dental fluorosis in children.

BACKGROUND: For many years, topical use of fluorides has gained greater popularity than systemic use of fluorides. A possible adverse effect associated with the use of topical fluoride is the development of dental fluorosis due to the ingestion of excessive fluoride by young children with developing teeth. OBJECTIVES: To describe the relationship between the use of topical fluorides in young children and the risk of developing dental fluorosis. SEARCH STRATEGY: Electronic search of the Cochrane Oral Health Group Trials Register, CENTRAL, MEDLINE, EMBASE, BIOSIS, Dissertation Abstracts and LILACS/BBO. Reference lists from relevant articles were searched. Date of the most recent searches: 9th March 09. SELECTION CRITERIA: Randomised controlled trials (RCTs), quasi-RCTs, cohort studies, case-control studies and cross-sectional surveys, in which fluoride toothpastes, mouthrinses, gels, foams, paint-on solutions, and varnishes were compared to an alternative fluoride treatment, placebo or no intervention group. Children under the age of 6 years at the time topical fluorides were used. DATA COLLECTION AND ANALYSIS: Data from all included studies were extracted by two review authors. Risk ratios for controlled, prospective studies and odds ratios for case-control studies or cross-sectional surveys were extracted or calculated. Where both adjusted and unadjusted risk ratios or odds ratios were presented, the adjusted value was included in the meta-analysis. MAIN RESULTS: 25 studies were included: 2 RCTs, 1 cohort study, 6 case-control studies and 16 cross-sectional surveys. Only one RCT was judged to be at low risk of bias. The other RCT and all observational studies were judged to be at moderate to high risk of bias. Studies were included in four intervention/exposure comparisons. A statistically significant reduction in fluorosis was found if brushing of a child's teeth with fluoride toothpaste commenced after the age of 12 months odds ratio 0.70 (random-effects: 95% confidence interval 0.57 to 0.88) (data from observational studies). Inconsistent statistically significant associations were found between starting using fluoride toothpaste/toothbrushing before or after the age of 24 months and fluorosis (data from observational studies). From the RCTs, use of higher level of fluoride was associated with an increased risk of fluorosis. No significant association between the frequency of toothbrushing or the amount of fluoride toothpaste used and fluorosis was found. AUTHORS' CONCLUSIONS: There should be a balanced consideration between the benefits of topical fluorides in caries prevention and the risk of the development of fluorosis. Most of the available evidence focuses on mild fluorosis. There is weak unreliable evidence that starting the use of fluoride toothpaste in children under 12 months of age may be associated with an increased risk of fluorosis. The evidence for its use between the age of 12 and 24 months is equivocal. If the risk of fluorosis is of concern, the fluoride level of toothpaste for young children (under 6 years of age) is recommended to be lower than 1000 parts per million (ppm).More evidence with low risk of bias is needed. Future trials assessing the effectiveness of different types of topical fluorides (including toothpastes, gels, varnishes and mouthrinses) or different concentrations or both should ensure that they include an adequate follow-up period in order to collect data on potential fluorosis. As it is unethical to propose RCTs to assess fluorosis itself, it is acknowledged that further observational studies will be undertaken in this area. However, attention needs to be given to the choice of study design, bearing in mind that prospective, controlled studies will be less susceptible to bias than retrospective and/or uncontrolled studies.

Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents.

BACKGROUND: Caries (dental decay) is a disease of the hard tissues of the teeth caused by an imbalance, over time, in the interactions between cariogenic bacteria in dental plaque and fermentable carbohydrates (mainly sugars). The use of fluoride toothpaste is the primary intervention for the prevention of caries. OBJECTIVES: To determine the relative effectiveness of fluoride toothpastes of different concentrations in preventing dental caries in children and adolescents, and to examine the potentially modifying effects of baseline caries level and supervised toothbrushing. SEARCH STRATEGY: A search was undertaken on Cochrane Oral Health Group's Trials Register, CENTRAL, MEDLINE and several other databases. Reference lists of articles were also searched. Date of the most recent searches: 8 June 2009. SELECTION CRITERIA: Randomised controlled trials and cluster-randomised controlled trials comparing fluoride toothpaste with placebo or fluoride toothpaste of a different concentration in children up to 16 years of age with a follow-up period of at least 1 year. The primary outcome was caries increment in the permanent or deciduous dentition as measured by the change in decayed, (missing), filled tooth surfaces (D(M)FS/d(m)fs) from baseline. DATA COLLECTION AND ANALYSIS: Inclusion of studies, data extraction and quality assessment were undertaken independently and in duplicate by two members of the review team. Disagreements were resolved by discussion and consensus or by a third party. The primary effect measure was the prevented fraction (PF), the caries increment of the control group minus the caries increment of the treatment group, expressed as a proportion of the caries increment in the control group. Where it was appropriate to pool data, network meta-analysis, network meta-regression or meta-analysis models were used. Potential sources of heterogeneity were specified a priori and examined through random-effects meta-regression analysis where appropriate. MAIN RESULTS: 75 studies were included, of which 71 studies comprising 79 trials contributed data to the network meta-analysis, network meta-regression or meta-analysis.For the 66 studies (74 trials) that contributed to the network meta-analysis of D(M)FS in the mixed or permanent dentition, the caries preventive effect of fluoride toothpaste increased significantly with higher fluoride concentrations (D(M)FS PF compared to placebo was 23% (95% credible interval (CrI) 19% to 27%) for 1000/1055/1100/1250 parts per million (ppm) concentrations rising to 36% (95% CrI 27% to 44%) for toothpastes with a concentration of 2400/2500/2800 ppm), but concentrations of 440/500/550 ppm and below showed no statistically significant effect when compared to placebo. There is some evidence of a dose response relationship in that the PF increased as the fluoride concentration increased from the baseline although this was not always statistically significant. The effect of fluoride toothpaste also increased with baseline level of D(M)FS and supervised brushing, though this did not reach statistical significance. Six studies assessed the effects of fluoride concentrations on the deciduous dentition with equivocal results dependent upon the fluoride concentrations compared and the outcome measure. Compliance with treatment regimen and unwanted effects was assessed in only a minority of studies. When reported, no differential compliance was observed and unwanted effects such as soft tissue damage and tooth staining were minimal. AUTHORS' CONCLUSIONS: This review confirms the benefits of using fluoride toothpaste in preventing caries in children and adolescents when compared to placebo, but only significantly for fluoride concentrations of 1000 ppm and above. The relative caries preventive effects of fluoride toothpastes of different concentrations increase with higher fluoride concentration. The decision of what fluoride levels to use for children under 6 years should be balanced with the risk of fluorosis.

A case study of multiple-treatments meta-analysis demonstrates that covariates should be considered.

OBJECTIVE: To illustrate the potential and challenges of the simultaneous analysis of a network of trials, using as a case study the investigation of the relative effectiveness of four topical fluoride treatments and two control interventions (placebo and no treatment) in preventing dental caries in children. STUDY DESIGN AND SETTING: We performed multiple-treatments meta-analysis within a Bayesian framework by synthesizing six Cochrane reviews. We explored the compatibility between direct and indirect evidence and adjusted the results using a meta-regression model to take into account differences in the year of randomization across studies. RESULTS: The validity of our conclusions for the superiority of fluoride toothpaste as indicated from the initial network analysis using Bayesian methods was challenged when we adjusted for possible confounders. The network was dominated by studies comparing placebo with toothpaste, which were older and had been carried out in populations with higher baseline risk than studies involving other fluoride modalities. CONCLUSION: After adjusting for possible differences across studies, we did not find clear evidence that any topical fluoride modality is more effective than any other. Multiple-treatments meta-analysis methods allow for more detailed investigations than naïve methods in the analysis of indirect evidence on treatment effects.

Prognostic factors in the treatment of generalized aggressive periodontitis: I. Clinical features and initial outcome.

AIMS: The aims of this study were to investigate prognostic factors for initial response to non-surgical periodontal treatment for generalized aggressive periodontitis. METHODS: Seventy-nine patients with generalized aggressive periodontitis were included in this prospective follow-up intervention study. Patients' clinical and demographic parameters were collected at baseline and 10 weeks following a standard course of treatment (four visits of non-surgical root surface debridement together with OHI as required). The relationship between clinical variables and treatment outcome were analysed at site-specific level by chi(2) analysis and for patient-specific variables by logistic regression. RESULTS: In general, there was a good response to the treatment provided. In deep sites the mean pocket depth reduction was 2.11+/-2.01 mm. Site-specific analysis showed that the presence of plaque had a small but significant predictive effect on outcome (odds ratio 1.4). Sites on teeth with grade II/III mobility showed a significantly reduced response to treatment. Twenty-five patients were classified as "non-responders". Current smoking was strongly associated with non-responding patients (odds ratio 3.8) in a logistic regression model; plaque, baseline bleeding and initial pocket depth were not significantly associated with treatment outcomes. CONCLUSIONS: Overall, the results emphasize the importance of smoking as a negative prognostic factor, and suggest that treatment outcomes may be determined by a wide range of different determinants requiring further study.

Diferenças de pressão arterial sono-vigília e sua associação com a medida da obesidade abdominal em hipertensos / The relationship between the decrease of blood pressure during sleep-wake period and the abdominal fat measurement in hypertensive individuals

Trata-se de um estudo de delinamento transversal que busca investigar a relação entre a queda da pressão arterial no período vigília-sono e medida da gordura corpoaral em hipertensos...