Method: The meta-analysis consisted of data from 2664 healthy adult subjects who participated in 41 clinical studies. In each study, subjects were randomly assigned to the 0.454% stabilized SnF2 SHMP dentifrice group for daily use over periods ranging from 2 weeks to 2 years depending on study design. In each study, oral safety was assessed via clinical examination or voluntary report. Adverse events (AE) were summarized both by subject and event occurrence and assessed for severity and causality.
Result: The study population exhibited considerable diversity in demographics, behaviors, and oral health. Of the 2664 subjects assigned the SnF2 SHMP dentifrice, 50 subjects (1.9% of the population) had an AE, with a 95% confidence interval of (1.4%, 2.5%). Desquamation was the most frequent AE identified in 17 subjects (0.6% of the population), with a 95% confidence interval of (0.4%, 1.0%). This AE was mild in severity, and contributed minimally (0.08% of the population) dropout. Other findings were less common, and overall, only 8 subjects discontinued use due to a treatment-related AE.
Conclusion: This inclusive meta-analysis demonstrated that a 0.454% stannous fluoride dentifrice with sodium hexametaphosphate was generally well-tolerated over periods of up to 2 years daily use, with mild transient desquamation (<1%) representing the most common finding.