Clinical Study Evaluating 0.454% Stannous Fluoride Dentifrice on Established Gingivitis

Objective: A double-blind, randomized controlled 3-month clinical trial was conducted to evaluate the effects of a 0.454% stannous fluoride sodium hexametaphosphate dentifrice on established gingivitis. Methods: Adults with mild gingivitis were randomized to a therapeutic dentifrice with 0.454% stannous fluoride sodium hexametaphosphate dentifrice (Crest® ProHealth™) or a negative dentifrice control (Crest® Cavity Protection). No prophylaxis was administered in this treatment study, subjects were simply dispensed assigned test products, and instructed on at-home unsupervised brushing. Efficacy was measured at baseline and Month 3 via a whole mouth clinical gingivitis index (Loe-Silness), while safety was assessed from examination and interview. Results: A total of 70 subjects (35 per group) were evaluated at Month 3. That population averaged 31 years of age, mean (SD) gingivitis scores were 0.27 (0.13), and groups were balanced with respect to demographics and gingivitis scores. At Month 3, the 0.454% stannous fluoride group had experienced a 54% reduction in gingivitis, and a 56% reduction in bleeding, differing significantly (p<0.001) from baseline on each endpoint. Between-group comparisons showed a 24% reduction in gingivitis and a 23% reduction in gingivitis, with the 0.454% stannous fluoride dentifrice differing significantly from the negative control. Adverse events were limited to mild oral irritation (both groups), with no early “for cause” dropouts. Conclusion: In a general population, 3-month use of 0.454% stannous fluoride sodium hexametaphosphate dentifrice for the treatment of gingivitis resulted in 23-24% reductions in gingivitis and bleeding relative to a regular dentifrice control.