Comparative tooth whitening and extrinsic tooth stain prevention efficacy of a new dentifrice and a commercially available tooth whitening dentifrice: six-week clinical trial.

Objective: The objective of this six-week, examiner-blind clinical study was to assess the tooth whitening and extrinsic stain prevention efficacy of a new dentifrice delivering 1.0% hydrogen peroxide, 0.243% sodium fluoride, and sodium tripolyphosphate in a high-cleaning silica base (Test Dentifrice) relative to that of a commercially available hexametaphosphate-containing whitening dentifrice (Positive Control Dentifrice).
Methodology: Following a baseline oral soft tissue examination and scoring of extrinsic tooth stain and tooth shade, qualifying adult male and female subjects from the Mississauga, Ontario, Canada area were randomized into either the Test or Positive Control Dentifrice group. The two groups were balanced for age, tobacco use, extrinsic tooth stain, and tooth shade scores. All subjects received a dental prophylaxis, and were provided with a supply of their assigned product and a soft-bristled adult toothbrush for use at home. Subjects were instructed to brush their teeth for two minutes twice daily (morning and evening) using only the dentifrice 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. Oral soft tissue, extrinsic tooth stain and tooth shade assessments for each subject were repeated after two and six weeks of product use. All statistical tests were two-sided and employed a level of significance of alpha = 0.05.
Results: Seventy-six (76) subjects complied with the protocol and completed the entire study. At both the two-week and six-week examinations, the Test Dentifrice prevented statistically significant (p < 0.05) more tooth stain as compared to the Positive Control Dentifrice. Also, at the two-week and six-week examinations, the Test Dentifrice provided statistically significant (p < 0.05) greater tooth whitening as compared to the Positive Control Dentifrice (2.64 and 3.77 shade rank reductions, respectively).
Conclusion: A new whitening dentifrice, delivering 1.0% hydrogen peroxide, 0.243% sodium fluoride, and sodium tripolyphosphate in a high-cleaning silica base provides a statistically significant greater level of efficacy for both tooth whitening and prevention of extrinsic tooth stain than the commercially available Positive Control Dentifrice.