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.

Extrinsic Stain Removal Effectiveness of a New Whitening Dentifrice.

OBJECTIVE: This study was conducted to evaluate the effectiveness of Arm & Hammer (A&H) Truly Radiant Rejuvenating toothpaste in removing extrinsic tooth stain compared to that of a conventional fluoride/silica-containing dentifrice. METHODS: This was a randomized, examiner-blind, parallel-design study with two groups of subjects who brushed unsupervised with their assigned dentifrice for two minutes, twice daily, for five days. Extrinsic stain was measured on the labial surfaces of the eight incisor teeth by the Modified Lobene Stain Index (MLSI) at baseline and following five days of product use. After balancing for baseline MLSI, beverage and tobacco use, fifty-four healthy adults with existing stain were randomly distributed into two comparable groups: Arm and Hammer Truly Radiant Rejuvenating toothpaste or Colgate Cavity Protection toothpaste (negative control). Within-treatment comparisons between baseline and day five were made using matched-pair t-tests, and between-treatment comparisons of MSLI scores were performed using ANCOVA, with baseline scores as covariates. RESULTS: Twenty-eight subjects in the Truly Radiant Rejuvenating toothpaste group and twenty-six subjects in the negative control group completed the study. The groups had comparable mean scores at baseline (p > 0.05). The Truly Radiant Rejuvenating toothpaste produced a statistically significant 23.1% total (composite) stain reduction from baseline after five days of product use (p < 0.0001) while the negative control was essentially unchanged (p > 0.05). Between-treatment analysis showed statistically significantly (p < 0.0001) greater stain removal for Truly Radiant Rejuvenating toothpaste compared to the Colgate control following five days of product use. There were no adverse events reported during the study. CONCLUSION: The A&H Truly Radiant Rejuvenating toothpaste is safe and effective in reducing extrinsic stain compared to a regular toothpaste control.