Purpose: To compare the efficacy of a 0.454% w/w stannous fluoride containing anhydrous dentifrice and a negative control dentifrice containing 1,000 ppm fluoride (as sodium monofluorophosphate) at reducing dentin hypersensitivity over an 8-week period, following twice daily brushing.
Methods: This was a randomized, examiner blind, two-treatment arm, stratified (by maximum baseline Schiff sensitivity score), parallel design, single-site study in 118 subjects, who had at least two sensitive teeth, and met all the criteria at the screening and baseline visit. The study was conducted in Las Vegas, NV, USA. Tactile threshold (Yeaple Probe) and evaporative (air-blast) sensitivity (with Schiff sensitivity scale) were employed as clinical measures to compare the efficacy of the test dentifrice containing 0.454% w/w stannous fluoride to the negative control (Colgate Cavity Protection) at reducing sensitivity at Weeks 4 and 8.
Results: 117 subjects completed the clinical study. At the 4- and 8-week time points, between treatment analyses demonstrated the test dentifrice to be significantly better at relieving subjects' sensitivity, for both validated clinical measures, compared to the negative control (at 4 weeks Schiff P < 0.0001 tactile threshold P < 0.0001; at 8 weeks Schiff P < 0.0001; tactile threshold P < 0.0001).