Randomized Controlled Trials Assessing Exposure Frequency Effects of Stannous Fluoride on Gingivitis.

Abstract

Objective: To evaluate the exposure frequency effect of 0.454% stannous fluoride (SnF₂) toothpaste in controlling gingivitis.

Methods: Two randomized controlled trials enrolled generally healthy adults with gingivitis. The study duration was 1 mo (study 1) and 3 mo (study 2). Gingivitis was assessed using the Löe-Silness Gingival Index (LSGI) at baseline, 1 mo (both studies), and 3 mo (study 2); bleeding scores were derived from the LSGI. Study groups consisted of positive control (twice-daily use of 0.454% SnF₂ toothpaste), experimental group (brushing in the morning with SnF₂ toothpaste and in the evening with 0.76% sodium monofluorophosphate [SMFP] toothpaste), and negative control (twice-daily use of SMFP toothpaste). The primary endpoint was number of bleeding sites.

Results: Study 1 and study 2 each enrolled and randomized 90 participants; 86 and 89 participants, respectively, completed the trials. At baseline, the mean (SD) number of bleeding sites was 47.6 (18.54) in study 1 and 41.5 (17.84) in study 2. At 3 mo (study 2), the positive control produced 51.3% fewer bleeding sites, and the experimental group produced 32.5% fewer bleeding sites versus the negative control (P < 0.001 for both). At 1 mo, the positive control produced 45.1% (study 1) and 45.8% (study 2) fewer bleeding sites versus the negative control (P < 0.001 for both), and the experimental group produced 33.0% (study 1) and 24.8% (study 2) fewer bleeding sites, respectively, versus the negative control (P ≤ 0.002 for both). The benefit was observed as early as 1 mo and was consistent with 3-mo results.

Conclusion: This research is to our knowledge the first to demonstrate a gingivitis-reduction response effect for the frequency of bioavailable SnF₂ toothpaste use, with maximum benefit from twice-daily use, followed by a single-daily exposure versus the negative control. Clinical trial registration numbers: NCT05916508 and NCT05916521.

Knowledge transfer statement: The results of this study can be used by dental professionals to guide their recommendations for therapeutic toothpaste for gingival health. Emphasis on the importance of twice-daily brushing with bioavailable stannous fluoride dentifrice will help patients optimize gingival health benefits achieved via self-care.