Oral Safety of 0.454% SnF₂ Dentifrice: Meta-analysis vs. Marketed Control

Objectives: This meta-analysis was conducted to evaluate oral safety of an experimental 0.454% SnF₂ dentifrice relative to a positive control.
Methods: Data from 10 clinical studies with 412 healthy adult subjects were included in the analysis. Of those, 4 were parallel studies 5 or 6 weeks in duration (long-term) and 6 were crossover studies with each treatment period < 1 week (short-term). In each parallel study, subjects were randomized to either the experimental 0.454% SnF₂ test dentifrice or a marketed 0.454% SnF₂ positive control dentifrice. In the crossover studies, subjects were randomized to the order they received the treatments. Oral soft and hard tissue safety was assessed via clinical examination or voluntary reports. Proportion of subjects with adverse events (AE) was summarized by study and treatment. Treatments were compared using generalized linear mixed model.
Results: Study population exhibited diversity in demographics, behaviors, and oral health. Of the 298 subjects that tested the test dentifrice, 32 (10.7%) had ≥1 AE. Of the 273 subjects that tested the positive control, 65 (23.8%) had ≥ 1 AE. Desquamation was the most frequent AE. In the long-term studies, the percent of subjects with ≥ 1 desquamation was 2% [95% CI of (0%, 7%)] in the test group and 18% [95% CI of (11%, 26%)] in the control group. In the short-term studies, the percent of subjects with ≥ 1 desquamation was 4% [95% CI of (2%, 8%)] in the test group and 13% [95% CI of (8%, 19%)] in the control group. The test group had significantly (p≤0.0014) lower occurrence of desquamation than the positive control. Other findings were less common, and no subject discontinued use due to a treatment-related AE.
Conclusions: This meta-analysis demonstrated that an experimental 0.454% SnF₂ dentifrice was generally well-tolerated with mild transient desquamation representing the most common finding.