Clinical studies to assess the extrinsic stain prevention and stain removal efficacy of a variant of a commercially available dentifrice containing a new dual silica system.

Objective: The objective of these two six-week, double-blind clinical studies was to compare the extrinsic stain prevention (Study #1) and stain removal (Study #2) efficacy of a new dentifrice (Colgate Total Advanced Toothpaste) containing 0.3% triclosan/ 2.0% polyvinylmethyl ether/maleic acid (PVM/MA) copolymer/0.243% sodium fluoride in a 17% dual silica base, to a commercially available fluoride dentifrice without tooth whitening ingredients (Crest Cavity Protection Toothpaste) containing 0.243% sodium fluoride in a silica base.

Methods: Following baseline examinations for extrinsic tooth stain and an oral tissue examination, qualifying adult male and female subjects from the northern and central New Jersey, USA areas were randomized for each study into two treatment groups which were balanced for gender and level of extrinsic tooth stain. Subjects received a full oral prophylaxis at the start of Study #1 only. All subjects were provided with their assigned product and a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for one minute twice daily (morning and evening) using only the dentifrice and toothbrush provided, and to refrain from using any other oral hygiene products for the entire six weeks of the study. There were no restrictions regarding diet or smoking habits during the course of the study. Examinations for extrinsic tooth stain and oral tissue assessments were repeated after three weeks and six weeks of product use.

Results: One-hundred fourteen (114) subjects participating in Study #1 and 119 subjects participating in Study #2 complied with the protocol and completed the entire study. In both studies, at the three-week and the six-week examinations, subjects who used the new dentifrice exhibited statistically significantly lower levels of extrinsic tooth stain area and extrinsic tooth stain intensity than did those subjects who used the commercially available fluoride control dentifrice.

Conclusion: A new dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride in a 17% dual silica base is more efficacious in the prevention and removal of extrinsic tooth stain than a commercially marketed fluoride dentifrice.