Clinical Effectiveness Evaluation of a New Whitening Dentifrice.

OBJECTIVE: This randomized controlled clinical trial was conducted to determine the effectiveness and safety of a new whitening dentifrice.

METHODS: One hundred eighty-two qualifying subjects were randomly assigned to either a whitening dentifrice group (Arm & Hammer Truly Radiant Toothpaste), a negative control dentifrice group (Colgate Cavity Protection Toothpaste), or a positive control dentifrice group (Crest 3-D White Radiant Mint Toothpaste) and were instructed to brush twice daily with their assigned dentifrice for six weeks. Extrinsic tooth stain was assessed using a Modified Lobene Stain Index (MLSI) and tooth shade was assessed using the VITA Classic Shade Guide at baseline and after five days and two, four, and six weeks of dentifrice use. Safety was monitored by clinical examinations and panelist assessment at each evaluation period.

RESULTS: The Arm & Hammer Truly Radiant group showed a statistically significant improvement from baseline in mean composite MLSI and VITA shade at each examination period (p < 0.0001). Significant improvements on day 5 progressively increased with increasing duration of product use. By week 6, there was a 45.4% reduction in stain and a 2.08 improvement in tooth shade. The between-group comparison revealed that Truly Radiant toothpaste was significantly more effective than both the negative and positive control dentifrices for these parameters (p < 0.0001) at each exam time.

CONCLUSION: This study showed that the new dentifrice formulation is safe and effective on stain removal and tooth whitening.