A 6-Month Randomized Controlled Trial to Measure the Efficacy of a Stannous Fluoride Toothpaste Stabilized With Nitrate and Phosphates (SNaP) on Dental Plaque and Gingivitis

Abstract: Background: The objective of this randomized controlled trial was the comparison of a stannous fluoride (SnF₂) dentifrice stabilized with nitrate and phosphates (test) to a regular fluoride dentifrice (negative control) for the control of plaque and gingivitis over 6 months. Methods: A total of 80 adult participants were enrolled in this study that was conducted in Loma Linda, California. After randomization and blinding of study personnel and patients, enrolled participants were provided instructions for the use of their assigned dentifrice. At three visits (0, 3, and 6 months), various gingival and plaque indices were collected to determine the clinical efficacy of the SnF₂ stabilized dentifrice. These results were compared with the results of the negative control dentifrice. Results: A total of 77 participants completed the study. The test dentifrice demonstrated statistically significant reductions versus baseline in all plaque and gingivitis indices after 3 and 6 months of product use. The negative control dentifrice demonstrated significant reductions versus baseline in all plaque indices, but not gingivitis indices, after 3 months of product use and in all plaque and gingivitis indices after 6 months of product use, with the exception of the interproximal gingivitis index, which did not reach statistical significance. The test SnF₂ dentifrice showed statistically significant reductions in all plaque and gingivitis indices compared to baseline and to the negative control dentifrice after 3 months and 6 months of product use (all: P < .001). Conclusions: The results of this clinical trial showed statistically significantly improved clinical outcomes for reduction of gingival inflammation and improvement in plaque control over 6 months when using a new SnF₂ dentifrice stabilized with nitrate and phosphates as compared to the results from a regular fluoride dentifrice. Practical Implications: This newly formulated SnF₂ dentifrice may be of benefit to patients who need help controlling plaque biofilm and in reducing gingivitis, leading to an improvement in overall oral health.