Randomized clinical trial evaluating stain removal efficacy of whitening dentifrice

Objectives: A clinical trial was conducted to assess the safety and effectiveness of whitening toothpaste relative to a positive control on extrinsic tooth stain.
Methods: This randomized controlled trial evaluated extrinsic tooth stain over a four-week period. After institutional review and informed consent, adult volunteers with natural extrinsic tooth stain were randomly assigned to either 1) twice daily use of a 0.243% sodium fluoride whitening dentifrice with an Oral-B Indicator soft manual toothbrush or 2) Crest^â 3D White Brilliance Toothpaste (0.243% sodium fluoride) with an Oral-B Indicator soft manual toothbrush. Stain was assessed on the facial surfaces of anterior teeth using the Interproximal Modified Lobene Stain Index (IMLSI) after two and four weeks of product use. Safety was assessed via clinical examination and interview. Groups were compared to Baseline using paired difference t-test. Analysis of covariance was used to compare between the two groups. The statistical comparisons were two-sided using a 5% level of significance.
Results: Mean (SD) age of the 50 evaluable subjects was 36.8 (8.14) years, with groups balanced on baseline stain levels (p=0.96). Both dentifrices showed significant (<0.001) stain reductions relative to Baseline on the whole tooth as well as interproximal and gingival surfaces at both time points. The Whitening Dentifrice group demonstrated a whole tooth stain reduction of 3.34 and 4.02 at Weeks 2 and 4, respectively. The Positive control group showed stain reduction of 3.30 and 3.94 at Weeks 2 and 4, respectively. No significant difference in stain was observed between the two groups at either week (p≥0.776). Both treatments were well-tolerated.
Conclusions: In a positively-controlled study, the tested whitening dentifrice significantly reduced extrinsic tooth stain with continuing improvement at each tested time point.