Comparative 12-Hour Antibacterial Effectiveness of a 0.454% Stannous Fluoride Dentifrice

Objective: A randomized controlled clinical trial was conducted to evaluate 12-hour, overnight antibacterial effectiveness of a stannous fluoride sodium hexametaphosphate dentifrice. Methods: The clinical study was a randomized, double-blind, 2-treatment, 3-period, crossover with 40 adults. All subjects received a marketed anticavity dentifrice for a 7-day acclimation and for use during the 7-day washout between treatment periods. Subjects were randomly assigned to a three period treatment sequence with 0.454% stabilized stannous fluoride sodium hexametaphosphate dentifrice (Crest® Pro-Health™) or a regular dentifrice control without stannous fluoride (Crest® Cavity Protection). Brushing was unsupervised, at-home for 1 minute twice daily for 7 days. Supragingival plaque samples were collected 12-hour post-brushing, diluted, plated and incubated using standard methods, and then total facultative anaerobic bacteria were enumerated (CFU/mL). Treatments were compared (log10 CFU/mL) using analysis of variance for crossover studies with a 5% significance level. Results: The study population ranged from 20-76 years of age, with females comprising 68%. At baseline, groups were balanced for 12-hour post-brushing total facultative anaerobic bacteria (p=0.855). After 7 days, the 0.454% stannous fluoride dentifrice group had significantly (p=0.015) lower mean 12-hour post-brushing total facultative anaerobic bacteria compared to the regular dentifrice control. Conclusion: In a randomized controlled trial, 7-day use of 0.454% stannous fluoride resulted in a significant (p<0.05) reduction in 12-hour post-brushing total facultative anaerobic bacteria in dental plaque compared to a regular dentifrice control.