Randomized In Situ Clinical Trial Evaluating Erosion Protection Efficacy of a 0.454% Stannous Fluoride Dentifrice.

OBJECTIVES: To assess the protective effects of a 0.454% stabilized stannous fluoride dentifrice and a marketed triclosan dentifrice against enamel erosion in a 10-day in situ model.

METHODS: This was a double-blind, randomized, 2-treatment, 4-period, crossover in situ trial involving healthy adult participants. Participants were randomized to a treatment sequence involving the following products: a highly bio-available 0.454% stannous fluoride dentifrice (Procter & Gamble) and a marketed dentifrice control containing 0.24% sodium fluoride and 0.3% triclosan (Colgate-Palmolive). Each study period took place over 10 days. Participants wore an intra-oral appliance retaining 2 polished human enamel samples for 6 hours per day. Two times per day they swished with the assigned dentifrice slurry and four times per day they swished with 250ml of orange juice (25 ml per minute) over a 10-minute period. Contact profilometry measurements were made for each sample at baseline and day 10 to determine surface change.

RESULTS: Thirty-six participants were enrolled and 33 completed the study (mean age = 40.5 years). The stannous fluoride dentifrice demonstrated 93.5% less enamel loss than the NaF/triclosan dentifrice (p<0.001) at Day 10, with median enamel loss of 0.097 μm and 1.495 μm, respectively. Both products were well tolerated.

CONCLUSION: The stannous fluoride dentifrice demonstrated significantly greater erosion protection efficacy relative to the NaF/triclosan dentifrice in this randomized in situ clinical trial. This article is protected by copyright. All rights reserved.