A randomized clinical study to assess the extrinsic staining profiles of stannous- and triclosan-containing dentifrices.

Purpose: To evaluate the extrinsic stain profiles of two experimental stannous-containing dentifrice prototypes compared to two marketed control dentifrices.

Methods: This was a 5-week, randomized, four-treatment, parallel group, double-blind clinical trial of healthy adults. Following a baseline Lobene Stain Index evaluation, subjects received a prophylaxis limited to the 12 anterior teeth to remove surface stain and calculus. They were randomly assigned based on stain scores to one of the four treatment groups: one of two experimental stannous-containing sodium fluoride dentifrices; a non-staining marketed triclosan dentifrice (Colgate Total); or a 0.454% stannous fluoride dentifrice (Crest Gum Care). Subjects brushed for 1 minute twice daily at home with their assigned dentifrice. Stain examinations were repeated at Week 3 and Week 5 to assess treatment differences.

Results: For the 96 subjects completing the study, Lobene stain composite mean scores--as well as extent (area) and intensity average scores--were significantly lower in the two experimental stannous-containing dentifrice groups and the Colgate Total group when compared to Crest Gum Care (P < 0.0001) at both Weeks 3 and 5. There were no statistically significant differences (P > 0.145) in stain accumulation at either time point between the experimental stannous groups and the Colgate Total group by any Lobene stain measure (composite, extent, intensity). All dentifrices were well-tolerated.