Extrinsic Stain Removal Clinical Study of a New Dentifrice

OBJECTIVE: The objective of this randomized, double-blind, parallel-group clinical study was to compare the tooth whitening (extrinsic stain removal) efficacy of Colgate Simply White, a new dentifrice formulation (1.0% hydrogen peroxide, 0.243% sodium fluoride and sodium tripolyphosphate in a high cleaning silica base) to a placebo dentifrice (0.243% sodium fluoride in a silica base) as measured by the Modified Lobene Stain Index. METHODS: Following a baseline examination for extrinsic tooth stain, qualifying adult male and female subjects from the Buffalo, New York area were randomized into two treatment groups which were well balanced for gender, age and level of extrinsic tooth stain. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice, using a soft bristled toothbrush that was provided. Examinations for extrinsic tooth stain were done at 4 and 8 weeks of product use. RESULTS: At both the 4 and 8 week stain removal examinations, subjects using the Colgate Simply White dentifrice exhibited statistically significantly lower levels of extrinsic tooth stain area and intensity than those subjects who used the placebo dentifrice, i.e. 32% (area), 22% intensity at 4 weeks and 54% and 44% at 8 weeks. CONCLUSION: The results of this clinical study support the conclusion that the Colgate Simply White dentifrice formulation containing hydrogen peroxide/sodium fluoride/sodium tripolyphosphate is superior, as compared to the placebo dentifrice, in tooth whitening (stain removal) efficacy.