A randomised clinical study investigating efficacy of a stannous fluoride toothpaste in improving gingival health after 3?weeks’ use

摘要

This 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. Eligible 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. A 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. Three 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.