Abstract
Background
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.
Methods
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.
Results
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.
Conclusion
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.
A prospective, randomized clinical study on the effects of an amine fluoride/stannous fluoride toothpaste/mouthrinse on plaque, gingivitis and initial caries lesion development in orthodontic patients
