Clinical Plaque and Gingivitis Effects of Bioavailable SnF₂ Dentifrice

Objectives: The objective of the three-month clinical trial was to assess the anti-plaque and anti-gingivitis efficacy of a 0.454% bioavailable stannous fluoride (SnF₂) dentifrice relative to a negative control dentifrice.
Methods: This randomized, controlled, double-blind, parallel-group study enrolled 90 healthy adult volunteers with mild to moderate gingivitis. After baseline examinations, subjects were randomly assigned to either a bioavailable 0.454% SnF₂ dentifrice or a negative control (0.76% sodium monofluorophosphate) dentifrice. Subjects were instructed to brush twice daily for one minute each time with the assigned dentifrice. Clinical examinations including oral hard and soft tissue safety examinations and efficacy measures based on Turesky Modified Quigley-Hein Index (TMQH) and Löe-Silness (LS) Gingival Index were performed at baseline and at 1 and 3 months. All statistical comparisons were two-sided at the 0.05 level of significance.
Results: Eighty-six subjects completed the study. Mean age (SD) was 42.3 (13.7) years. Treatment groups were balanced in demographic characteristics (p>0.764) and efficacy measurements (p>0.163) at Baseline. After one month of product use, SnF₂ dentifrice resulted in a 24.7% reduction in plaque (P<0.001), a 13.7% reduction in LS gingivitis (P<0.001), and a 46.8% reduction in number of bleeding sites (P<0.001) relative to the negative control dentifrice. Clinical results at Month 3 were consistent with Month 1 findings, with a 19.4% reduction in plaque (P<0.001), a 12.8% reduction in LS gingivitis (P<0.001), and a 37.0% reduction in number of bleeding sites (P<0.001) versus the negative control. Test dentifrices were well tolerated.
Conclusions: Intermediate (Month1) and long term (Month3) anti-plaque and anti-gingivitis benefits were demonstrated for the 0.454% bioavailable SnF₂ dentifrice in this clinical trial.