Clinical Evaluation on Extrinsic Stain Prevention of a Whitening Dentifrice

Objective:An 8-week randomized, double-blind, parallel group clinical study was conducted in the Chengdu, China area to assess the extrinsic stain prevention efficacy of the two commercially available dentifrices: (1) a dentifrice containing 0.321% sodium fluoride and 20% high cleaning silica (HCS) in a silica base (Test dentifrice); and (2) a dentifrice containing 0.321% sodium fluoride in a silica base (Placebo fluoride dentifrice). Methods: Following the collection of baseline scores and subsequent prophylaxis, one hundred fifty-one subjects were selected and randomized to one of two treatment groups, balancing for stain levels, gender and age. Throughout the eight-week treatment period, subjects brushed twice daily (morning and evening) for one minute with the assigned dentifrice. One hundred and forty-four subjects completed the clinical study. Extrinsic dental stain examinations, which included mean stain area and mean stain intensity, were conducted at baseline, four and eight weeks. The same dental examiner conducted examinations on the subjects at each examination. No adverse events were reported, and subjects who discontinued the study did so for reasons unrelated to the dentifrices. Results: After four-week use of their assigned products, those subjects in the test dentifrice group demonstrated a statistically significant (p<0.05) stain area reduction of 19.7% and stain intensity reduction of 19.1%, as compared to the fluoride placebo dentifrice group. After eight-week use of their assigned products, those subjects in the test dentifrice group demonstrated a statistically significant (p<0.05) stain area reduction of 20.4% and stain intensity reduction of 17.6%, as compared to the fluoride placebo dentifrice group. Conclusion: the use of a dentifrice containing 0.321% sodium fluoride and 20% HCS is effective in preventing natural extrinsic dental stain, as compared to a placebo fluoride dentifrice.