The objective of this double-blind clinical study was to investigate the tooth whitening efficacy of a variation in formula of a commercially available dentifrice (Colgate Total Toothpaste). The variation (Colgate Total Plus Whitening Toothpaste) was the addition of high cleaning silica to the existing formulation. Following a baseline examination for extrinsic tooth stain, qualifying adult male and female subjects from the Mississauga, Ontario, Canada area were randomized into two treatment groups which were 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. Examinations for extrinsic tooth stain were repeated after six weeks' use of the study dentifrices. Ninety-three (93) subjects complied with the protocol and completed the entire study. At the six-week examination, subjects assigned to the new dentifrice formulation group exhibited statistically significantly lower levels of extrinsic tooth stain area and extrinsic tooth stain intensity than did those subjects assigned to the Colgate Total Toothpaste group.
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