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.