Extrinsic Stain Removal Efficacy of a 0.454% Stannous Fluoride Dentifrice

Objectives: The objective of this study was to assess the extrinsic stain removal benefit delivered by a Stannous Fluoride dentifrice (SnF2) and a positive control dentifrice over a two-week period.
Methods: This study utilized a randomized, two-week, double-blind, parallel group design. A total of 50 generally healthy adults with visible extrinsic tooth stain were enrolled in the study. At Baseline, an Interproximal Modified Lobene (IML) examination was performed on the facial surfaces of the twelve anterior teeth. The two teeth with the highest IML composite scores were selected as the test teeth. Subjects were stratified on stain scores of the two test teeth, and gender, and randomized to one of two treatment groups: experimental 0.454% Stannous Fluoride dentifrice or Colgate Total Whitening â dentifrice. Then, subjects were instructed to use the test product following the on-package brushing instructions at home over the two week study duration. Tooth color was reassessed at Week Two. The Baseline to post-treatment average change in stain score was tested using paired t-tests. Analysis of covariance (ANCOVA) with treatment as a factor and Baseline Lobene score as the covariate was used to assess treatment differences post-treatment. All comparisons were two-sided using a 5% level of significance.
Results: Fifty subjects were randomized, received treatment and completed the study. The treatment groups were well balanced at Baseline for stain values (p>0.18) and with respect to baseline demographic characteristics (p>0.08). Both groups showed statistically significant reductions in IML stain scores at Week Two (p < 0.0001) relative to Baseline. The experimental SnF2 group demonstrated significantly less IML stain overall and for interproximal surfaces than the positive control group (p<0.0012).
Conclusions: The study demonstrated the statistically significant extrinsic stain removal efficacy for the 0.454% stannous fluoride dentifrice relative to Baseline and the positive control.