The relative clinical efficacy of three 0.454% stannous fluoride dentifrices for the treatment of gingivitis over 3 months.

PURPOSE To assess the safety and efficacy of three stannous fluoride (SnF2) dentifrices in the reduction of gingivitis versus a negative control dentifrice. METHODS This was a randomized, controlled, double-blind, four-treatment parallel group study. 120 healthy adult volunteers with established gingivitis were enrolled and randomly assigned to one of four dentifrice treatment groups (30/group): 0.454% SnF2 + citrate dentifrice A; 0.454% SnF2 + sodium hexametaphosphate dentifrice B; 0.454% SnF2 + pyrophosphate dentifrice C; or 0.76% sodium monofluorophosphate negative control group. Subjects brushed with their assigned dentifrice and an assigned regular manual toothbrush (Oral-B Indicator) for 1 minute twice daily for 12 weeks. Number of gingival bleeding sites and Loe-Silness Gingival Index (LSGI) scores were assessed at baseline and at Weeks 2, 4 and 12. RESULTS 120 subjects were enrolled and 112 completed the trial. Subjects had an average age (SD) of 39.31 (14.5) years; 67% of subjects were female. Overall baseline means (SD) were 81.2 (25.6) for number of bleeding sites and 1.51 (0.197) for mean LSGI score. Baseline disease levels were balanced across all treatment groups. At Week 2, SnF2 dentifrices A and B demonstrated a significant reduction in gingival bleeding sites versus the negative control; however, SnF2 dentifrice C was not significantly different from the negative control (P= 0.15). At Weeks 4 and 12, all SnF2 dentifrices demonstrated a significant gingival bleeding site reduction versus the negative control (P dentifrice B > dentifrice C for reduction in gingival bleeding sites (P< 0.001). The same trends were seen for LSGI scores. CLINICAL SIGNIFICANCE In this 12-week clinical study, all 0.454% SnF2 dentifrices delivered statistically significant reductions in the number of gingival bleeding sites relative to the negative control. Importantly, statistically significant efficacy differences were observed among the three 0.454% SnF2 dentifrices, demonstrating the important role that differences in formulation have on clinical efficacy.