IADR Abstract Archives
Short- and Long-term Oral Safety of 0.454% SnF2 Dentifrice
Objectives: This meta-analysis was conducted to evaluate the safety of an experimental 0.454% SnF2 dentifrice relative to a negative control.
Methods: Seven randomized, controlled clinical trials were included in the analysis. One hundred-eighty subjects participated in two 12-week, long-term, parallel clinical studies, and 156 subjects participated in five short-term crossover studies with treatment periods < 1 week in duration. In each parallel study, subjects were randomized to either the experimental 0.454% SnF2 dentifrice (test group) or a 0.76% Na monofluorophosphate dentifrice (Colgate® Cavity Protection, negative control) for daily use. In each crossover study, subjects were randomized to a sequence in which they received both products. Oral tissue safety was assessed via clinical examination or voluntary reports. Proportion of subjects with adverse events (AE)s was summarized by study and treatment. Treatments were compared using generalized linear mixed model.
Results: Subjects age ranged from 18 to 84 years, and diverse ethnicity was represented. Of the 243 subjects that tested the test dentifrice, 10 subjects (4.1%) had ≥ 1 AE. Of the 235 subjects that tested the negative control, 6 subjects (2.6%) had ≥ 1 AE. Desquamation was the most frequent AE. In the short-term studies, the percent of subjects with ≥ 1 desquamation was 5% [95% CI of (2%, 9%)] in the test group and 4% [95% CI of (2%, 9%)] in the negative control. The two treatments did not differ significantly from each other with respect to occurrence of desquamation (p = 0.5429). No AEs were reported or observed in the long-term studies. All AEs were mild in nature, and no subjects discontinued use due to a treatment-related AE.
Conclusions: In this meta-analysis of clinical trials up to 12 weeks in duration, the oral tissue safety profile of the experimental 0.454% SnF2 dentifrice was comparable to that of a regular cavity protection dentifrice.
Methods: Seven randomized, controlled clinical trials were included in the analysis. One hundred-eighty subjects participated in two 12-week, long-term, parallel clinical studies, and 156 subjects participated in five short-term crossover studies with treatment periods < 1 week in duration. In each parallel study, subjects were randomized to either the experimental 0.454% SnF2 dentifrice (test group) or a 0.76% Na monofluorophosphate dentifrice (Colgate® Cavity Protection, negative control) for daily use. In each crossover study, subjects were randomized to a sequence in which they received both products. Oral tissue safety was assessed via clinical examination or voluntary reports. Proportion of subjects with adverse events (AE)s was summarized by study and treatment. Treatments were compared using generalized linear mixed model.
Results: Subjects age ranged from 18 to 84 years, and diverse ethnicity was represented. Of the 243 subjects that tested the test dentifrice, 10 subjects (4.1%) had ≥ 1 AE. Of the 235 subjects that tested the negative control, 6 subjects (2.6%) had ≥ 1 AE. Desquamation was the most frequent AE. In the short-term studies, the percent of subjects with ≥ 1 desquamation was 5% [95% CI of (2%, 9%)] in the test group and 4% [95% CI of (2%, 9%)] in the negative control. The two treatments did not differ significantly from each other with respect to occurrence of desquamation (p = 0.5429). No AEs were reported or observed in the long-term studies. All AEs were mild in nature, and no subjects discontinued use due to a treatment-related AE.
Conclusions: In this meta-analysis of clinical trials up to 12 weeks in duration, the oral tissue safety profile of the experimental 0.454% SnF2 dentifrice was comparable to that of a regular cavity protection dentifrice.