The erosion protection efficacy of a stabilized stannous fluoride dentifrice: An in situ randomized clinical trial.

ABSTRACT

PURPOSE: To compare the enamel protection efficacy of a stabilized stannous fluoride dentifrice to a triclosan-containing sodium fluoride dentifrice using a 10-day in situ erosion model, in accordance with the American Dental Association Seal of Acceptance guidelines for enamel erosion control. METHODS: In this single-center, double-blind, randomized, supervised-usage, two-treatment, four-period, crossover study, healthy adult subjects were randomized to a treatment sequence involving the following products a 0.454% stannous fluoride (1,100 ppm F) dentifrice (Procter & Gamble) and a control dentifrice containing 0.243% sodium fluoride (1,100 ppm F) and 0.3% triclosan (Colgate-Palmolive). Each study period consisted of 10 treatment days. Subjects wore an intra-oral appliance fitted with two polished human enamel samples for 6 hours per treatment day. While wearing the appliance, subjects swished with their assigned dentifrice slurry for 60 seconds twice daily and with 250 ml orange juice over a 10-minute period four times daily. After 10 days, enamel specimens were removed and measured for surface loss using contact profilometry. RESULTS: 36 subjects were enrolled and 33 completed the study (mean age = 41.8 years). The stannous fluoride dentifrice demonstrated 90.3% less enamel loss than the NaF/triclosan dentifrice (P < 0.001) at Day 10, with median enamel loss of 0.279 µm and 2.877 µm, respectively. Both products were well tolerated. CLINICAL SIGNIFICANCE: The stannous fluoride dentifrice provided significantly greater protection against dental erosion relative to the NaF/triclosan dentifrice.