OBJECTIVE: To evaluate the exposure frequency effect of 0.454% stannous fluoride (SnF 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% SnF 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 ( CONCLUSION: This research is to our knowledge the first to demonstrate a gingivitis-reduction response effect for the frequency of bioavailable SnF 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.