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The effects of bioavailable gluconate chelated stannous fluoride dentifrice on gingival bleeding: Meta-analysis of eighteen randomized controlled trials.

ABSTRACT: AIM:To estimate gingivitis effects of a bioavailable gluconate chelated 0.454% stannous fluoride (SnF2 ) family of dentifrices in adult subjects versus positive (triclosan) and negative (NaF or MFP) controls when used ?3 months. MATERIALS AND METHODS:A meta-analysis evaluated bioavailable gluconate chelated SnF2 dentifrices versus a negative or positive control for gingival bleeding. RESULTS:In 18 randomized controlled trials (RCTs) with 2,890 subjects assessing SnF2 paste versus a negative or positive control, the average number of bleeding sites was reduced by 51% and 31%, respectively. The average change (95% CI) in number of bleeding sites was -16.3 (-27.8, -4.9) versus the negative control and -3.6 (-5.4, -1.8) versus the positive control. Subjects with localized or generalized gingivitis had 3.7 times better odds (95% CI [2.8, 5.0]) of shifting to generally healthy using SnF2 versus a negative control and 2.8 times better odds (95% CI [2.1, 3.9]) of shifting to generally healthy using SnF2 versus a positive control. The individual study risk of bias was deemed to be low in all categories of bias. CONCLUSION:This meta-analysis demonstrates significant gingivitis benefits of bioavailable SnF2 dentifrices when used ?3 months versus positive (triclosan) and negative (NaF or MFP) controls.

SUBMITTER: Biesbrock A

PROVIDER: S-EPMC6899529 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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The effects of bioavailable gluconate chelated stannous fluoride dentifrice on gingival bleeding: Meta-analysis of eighteen randomized controlled trials.

Biesbrock Aaron A He Tao T DiGennaro Joe J Zou Yuanshu Y Ramsey Dave D Garcia-Godoy Franklin F

Journal of clinical periodontology 20191201 12

<h4>Aim</h4>To estimate gingivitis effects of a bioavailable gluconate chelated 0.454% stannous fluoride (SnF<sub>2</sub> ) family of dentifrices in adult subjects versus positive (triclosan) and negative (NaF or MFP) controls when used ≤3 months.<h4>Materials and methods</h4>A meta-analysis evaluated bioavailable gluconate chelated SnF<sub>2</sub> dentifrices versus a negative or positive control for gingival bleeding.<h4>Results</h4>In 18 randomized controlled trials (RCTs) with 2,890 subjects ...[more]

PMID: 31562774

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Project description:BackgroundPlaque-induced gingivitis can be prevented and treated with regular effective oral hygiene, principally via mechanical cleaning with regular toothbrushing. To complement the mechanical plaque removal, antimicrobial ingredients can be incorporated into dentifrices to inhibit the growth of plaque. This study aimed to evaluate and compare gingivitis and the proportion of subjects moving between gingivitis severity (< 10, > 10 < 30, > 30% bleeding sites), and plaque reduction, following twice daily use of an experimental non-aqueous 0.454% weight/weight (w/w) stannous fluoride (SnF2) dentifrice, compared to a negative control dentifrice over 12 and 24 weeks.MethodThis was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. At baseline, after abstaining from toothbrushing overnight, subjects underwent MGI (modified gingival index), BI (bleeding index) and PI (plaque index) assessments. Eligible subjects, who met the inclusion/exclusion criteria, were stratified based on gender and baseline mean MGI score (Low ≤2.00 /High > 2.00) and randomized to treatment. Following randomization, subjects underwent a thorough dental prophylaxis and flossing. After 12 and 24 weeks of twice daily brushing with their allocated treatment, subjects returned to the site (with overnight plaque, having abstained from oral hygiene procedures for 8 h prior to visit) for MGI, BI and PI assessments. Treatment effect was evaluated by comparing the MGI, BI and PI scores.ResultsOne hundred and twenty-nine subjects were screened; 98 subjects were randomized and 90 subjects completed the study. Statistically significant differences between treatments, in favour of the 0.454% stannous fluoride dentifrice were observed, compared to the negative control dentifrice, for all outcome measures (MGI, BI, bleeding sites and PI at weeks 12 and 24 p < 0.0001). At 24 weeks, 71% of subjects in the 0.453% SnF2 treatment group demonstrated < 10% of bleeding sites.ConclusionA dentifrice containing 0.454% w/w SnF2 was shown to be superior to a standard dentifrice in controlling gingivitis and supra-gingival plaque, over a 24-week period. Over two thirds of subjects in the 0.454% SnF2 treatment group demonstrated a level of bleeding sites potentially representative of "clinical periodontal health" (< 10%) following a dental prophylaxis and 24 weeks of product use.Trial registrationThis study was retrospectively registered at ClinicalTrials.gov, on 11th Oct. 2019 (NCT04123665).

Project description:Numerous studies have investigated the effects of stannous ions on specific microbes and their efficacy in reducing dental plaque. Nonetheless, our understanding of their impact on the oral microbiome is still a subject of ongoing exploration. Therefore, this study sought to evaluate the effects of a stannous-containing sodium fluoride dentifrice in comparison to a zinc-containing sodium fluoride dentifrice and a control group on intact, healthy oral biofilms. Utilizing the novel 2bRAD-M approach for species-resolved metagenomics, and FISH/CLSM with probes targeting periodontal and caries associated species alongside Sn2+ and Zn2+ ions, we collected and analyzed in situ biofilms from 15 generally healthy individuals with measurable dental plaque and treated the biofilms with dentifrices to elucidate variations in microbial distribution. Although significant shifts in the microbiome upon treatment were not observed, the use of a stannous-containing sodium fluoride dentifrice primarily led to an increase in health-associated commensal species and decrease in pathogenic species. Notably, FISH/CLSM analysis highlighted a marked reduction in representative species associated with periodontitis and caries following treatment with the use of a stannous-containing sodium fluoride dentifrice, as opposed to a zinc-containing sodium fluoride dentifrice and the control group. Additionally, Sn2+ specific intracellular imaging reflected the colocalization of Sn2+ ions with P. gingivalis but not with other species. In contrast, Zn2+ ions exhibited non-specific binding, thus suggesting that Sn2+ could exhibit selective binding toward pathogenic species. Altogether, our results demonstrate that stannous ions could help to maintain a healthy oral microbiome by preferentially targeting certain pathogenic bacteria to reverse dysbiosis and underscores the importance of the continual usage of such products as a preventive measure for oral diseases and the maintenance of health.

Project description:ObjectivesTo compare the effectiveness of using a 0.454% stannous fluoride-containing dentifrice twice daily in relieving dentinal hypersensitivity (DH) in a Chinese population.Materials and methodsThis was a single-centre, randomized, controlled, examiner-blind, three-treatment-arm, parallel-group study in participants with clinically diagnosed DH. Subjects who met inclusion criteria (n = 197) were randomly allocated into 3 groups: test group (n = 66)-using a 0.454% stannous fluoride-containing dentifrice twice daily; positive control group (n = 64)-using a 5.0% calcium sodium phosphosilicate-containing dentifrice twice daily; negative control group (n = 67)-using a 1150 ppm of NaF dentifrice twice daily. Status of DH was assessed at week 4 and week 8 by the same independent examiner. Changes from baseline in Schiff sensitivity score, tactile threshold and Dentine Hypersensitivity Experience Questionnaire (DHEQ) score were analysed using analysis of covariance models. The DHEQ evaluated subject-perceived oral health-related quality of life (OHRQoL).ResultsStatistically significant improvements in mean Schiff scores (p < 0.0001 for all products at Weeks 4 and 8), tactile threshold (p < 0.0001 for test and negative control at Weeks 4 and 8: Week 4 p = 0.0040 and Week 8 p < 0.0001 for positive control) and all DHEQ scores (p < 0.01 for all groups) were observed. No statistically significant differences were observed in the adjusted mean between all dentifrices at both timepoints, potentially driven by a placebo effect. Forty-two treatment-emergent adverse events (TEAEs) were reported (n = 32 subjects), with 2 serious AEs (n = 1) in the test group. TEAEs were not considered treatment-related.ConclusionsAll groups demonstrated statistically significant improvements in Schiff score, tactile threshold and OHRQoL. However, due to a possible placebo effect in the negative control, there were no statistically significant differences between the dentifrices.Clinical relevanceThis study adds to the growing research exploring why the placebo effect is a common phenomenon in DH studies.Trial registrationClinicalTrials.gov Identifier: NCT04950465.

Project description:BackgroundThis examiner-blind, stratified, parallel study aimed to evaluate the anti-gingivitis efficacy of a non-aqueous (anhydrous) 0.454% w/w stannous fluoride toothpaste ('Test') versus a sodium monofluorophosphate toothpaste ('Control') in people with clinically-confirmed mild-moderate gingivitis. Plaque-induced gingivitis can progress to irreversible periodontitis if left untreated. This can be controlled by an effective oral hygiene regimen such as one including toothbrushing with a toothpaste containing the chemotherapeutic agent stannous fluoride. Long-term studies over 4-12 weeks have shown the efficacy of stannous fluoride; however, shorter term studies are needed to examine if the effects on measures of gingivitis and plaque control occur sooner.MethodsEligible participants were randomised to 3 weeks' twice-daily brushing (for 1 min) with Test or Control toothpastes. The primary efficacy variable was between-treatment difference in Bleeding Index (BI) at 3 weeks; secondary variables were between-treatment differences in number of bleeding sites, modified Gingival Index (MGI), and Turesky modification of the Quigley-Hein Plaque Index (TPI) at Weeks 2 and 3.ResultsA statistically significant (p < 0.0001) lower BI score was reported for Test (n = 65) versus Control (n = 65) groups at Week 2 (mean difference: - 0.07 [95% CI - 0.9, - 0.05]; 32.7% difference) and Week 3 (mean difference: - 0.06 [95% CI - 0.8, - 0.04]; 29.2% difference). The Test group also demonstrated statistically significant lower (all p < 0.0001 versus Control) number of bleeding sites (Weeks 2/3 mean difference [95% CI]: - 10.04 [- 12.3, - 7.5]/ - 8.2 [- 11.1, - 5.3] sites; 33.0%/29.3% difference); MGI score (Weeks 2/3 mean difference [95% CI]: - 0.09 [- 0.13, - 0.06]/ - 0.10 [- 0.14, - 0.06]; 4.3%/4.7% difference); overall TPI score (Weeks 2/3 mean difference [95% CI]: - 0.45 [- 0.55, - 0.35/ - 0.42 [- 0.53, - 0.30] difference; 16.0%/15.1% difference) and interproximal TPI score (Weeks 2/3 mean difference [95% CI]: - 0.42 [- 0.52, - 0.30]/ - 0.41 [- 0.52, - 0.29]; 14.6%/14.1% difference). Both toothpastes were generally well tolerated.ConclusionThree weeks' twice-daily brushing with the 0.454% w/w stannous fluoride Test toothpaste compared to the Control toothpaste led to statistically significant lower gingival bleeding, gingival inflammation and plaque levels in adults with mild-moderate gingivitis. These results indicate that plaque and gingivitis-reducing benefits of 0.454% w/w stannous fluoride may be seen from 2 weeks' use. Trial registration ClinicalTrials.gov Identifier: NCT04050722; 08/08/2019.

Dataset Information

The effects of bioavailable gluconate chelated stannous fluoride dentifrice on gingival bleeding: Meta-analysis of eighteen randomized controlled trials.

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The effects of bioavailable gluconate chelated stannous fluoride dentifrice on gingival bleeding: Meta-analysis of eighteen randomized controlled trials.

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