Gingivitis Treatment with 0.454% Stannous Fluoride Dentifrice: Clinical Meta-Analysis

Objectives: This meta-analysis was conducted to evaluate effects of 0.454% stannous fluoride dentifrice on established gingivitis, and to assess the utility of a gingivitis treatment clinical model. Methods: Subjects from two identical 3-month gingivitis treatment clinical trials were included in the pooled analysis. In each study, general subjects with mild gingivitis were randomized to Crest® ProHealth™ (0.454% stannous fluoride sodium hexametaphosphate) dentifrice or a regular anticavity dentifrice control (Crest® Cavity Protection). Brushing was unsupervised, and clinical outcomes were measured monthly using the whole mouth Gingivitis Index (GI). GI and bleeding data were analyzed separately using a general linear mixed model that included age and baseline, with treatment as a fixed effect and study as a random effect. Results: The meta-analysis included 167 subjects, with mean (SD) age of 37.6 (11.6) years, and mean GI score of 0.26 (0.15). Adjusted mean (SE) GI scores in the 0.454% stannous fluoride group were 0.19 (0.014) at Month 1, 0.19 (0.028) at Month 2, and 0.16 (0.050) at Month 3. Adjusted mean (SE) GI scores in the regular dentifrice control were 0.22 (0.014) at Month 1, 0.22 (0.028) at Month 2, and 0.20 (0.050) at Month 3. Treatments differed significantly (p<0.05) beginning at Month 1. Bleeding response was similar, with the 0.454% stannous fluoride group exhibiting the lowest scores at each time point. At Month 3, there were 11.1 (3.5) adjusted mean (SE) bleeding sites in the 0.454% stannous fluoride group compared to 14.4 (3.5) in the control, with treatments differing statistically (p=0.004). Both dentifrices were well tolerated. Conclusion: A 3-month treatment model in a general population showed significant 20% reductions in gingivitis and 23% reductions in bleeding with a 0.454% stannous fluoride dentifrice versus control.