Gingivitis to Health Improvement with Two-Step System

Objectives: A clinical study was conducted to assess anti-gingivitis benefit of a two-step system relative to a negative control.
Methods: After IRB review and informed consent, 49 volunteers with gingivitis were randomly assigned to twice daily use of either 1) two-step system (0.454% SnF₂ followed by 3.3% Sodium pyrophosphate) or 2) 0.76% NaMFP toothpaste (Colgate® Cavity Protection) as a negative control. Gingival health evaluations via Loë-Silness Gingivitis Index were performed at baseline and after four weeks of product use. The Gingivitis Case Definition from the 2017 World Workshop in Periodontology (Trombelli, Farina, Silva, & Tatakis, 2018) was used to evaluate subject-level gingival bleeding at baseline and the final visit as: generally healthy (< 10% bleeding sites), localized gingivitis (10-30% bleeding sites), or generalized gingivitis (>30% bleeding sites). Overall number of subjects that transitioned from either localized or generalized gingivitis to generally healthy status was evaluated and compared between two groups.

Results: 49 subjects (59% female) with an average age of 42.2 years were enrolled, and 47 completed the study. At Week 4, the two-step system exhibited significantly lower (p<0.0001) number of bleeding sites compared to control by 75% (full gingivitis outcomes were previously reported). Forty two percent of subjects in the two- step group transitioned from either localized or generalized gingivitis status to generally healthy, while all subjects in the control group remained in the gingivitis category. Significantly larger (p<0.001) proportion of subjects with localized or generalized gingivitis shifted to generally healthy status (<10% bleeding sites) using two-step system versus a negative control.

Conclusions: The two-step system demonstrated a significant oral health benefit to promote a transition from gingivitis to health after one month of use.