Efficacy of a Novel Stannous Fluoride Toothpaste Stabilized With Nitrate and Phosphates (SNaP) in Extrinsic Tooth Stain Removal: A Randomized Controlled Trial.

BACKGROUND: This study compared the extrinsic tooth stain removal efficacy of a 0.454% stannous fluoride dentifrice stabilized with nitrate and phosphates (SNaP) versus a non-whitening regular fluoride dentifrice (negative control) after 3 and 6 weeks of product use. METHODS: This phase III, double-blind, randomized, two-cell, parallel-group study was conducted on 80 healthy adults in Puerto Rico. After a baseline tooth stain assessment and oral examinations, study participants were randomly assigned to either the SNaP (test) group or a negative control group. Participants brushed their teeth twice daily for 2 minutes for the 6-week duration. The efficacy for extrinsic tooth stain removal was assessed via Lobene composite stain index, stain area index, and stain intensity index scores for each treatment group at baseline, 3 weeks, and 6 weeks. RESULTS: Seventy-eight participants completed the 6-week study. The SNaP dentifrice provided more stain removal relative to baseline tooth stain scores (3-week: 24.4%; 6-week: 35.6%; P less than .001) and more stain removal relative to the regular fluoride dentifrice (3-week: 24.3%; 6-week: 39.1%; P less than .001). CONCLUSION: The results indicate that the SNaP toothpaste provides a greater level of efficacy in the removal of extrinsic tooth stain as compared to a regular fluoride toothpaste when used twice a day, as measured with Lobene stain index at 3 weeks and 6 weeks. PRACTICAL IMPLICATIONS: A new stannous fluoride dentifrice stabilized with nitrate and phosphates offers greater efficacy in removing extrinsic tooth stain as compared to regular fluoride toothpaste.