Clinical Study to Determine the Stain Removal Effectiveness of a New Dentifrice Formulation.

Objectives: This randomized, prospective clinical trial was conducted to determine the safety and effectiveness of a new whitening dentifrice formulation in comparison to that of both a negative and a positive control dentifrice.

Methods: Seventy-nine qualifying subjects were randomly assigned to either the new whitening dentifrice (Arm & Hammer® Truly Radiant™ Clean & Fresh Toothpaste), a positive control whitening dentifrice (Crest® 3-D White® Radiant Mint Toothpaste), or a negative control regular dentifrice (Colgate® Cavity Protection Toothpaste). The subjects brushed with their assigned dentifrice for two minutes, twice daily, for five days. Extrinsic tooth stain was assessed using a Modified Lobene Stain Index (MLSI) at baseline and after five days of product use.

Results: All entering subjects completed the study. There were no significant differences (p > 0.05) in stain among the three groups at baseline. The Arm & Hammer Truly Radiant and positive control groups had statistically significant (p < 0.001) mean composite MLSI reduction scores of 13.2% and 7.8%, respectively, from baseline to day five. The negative control dentifrice group was virtually unchanged during this period. Intergroup comparisons showed the Truly Radiant group to have significantly greater stain removal (p < 0.0001) scores than the negative control. The Truly Radiant group also had greater stain removal than the positive control, though the differences were not statistically significant.

Conclusions: This study demonstrates that five-days' use of Arm & Hammer Truly Radiant Clean & Fresh dentifrice was significantly more effective in stain removal than a regular (non-whitening) dentifrice and comparable in effectiveness to a whitening dentifrice positive control.