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.

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.

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.