Safety and Tolerability of Vital Bleaching with Whitening Strips: Evidence from 32 Clinical Trials

Objective: This research summarizes an extensive clinical trials database collected as part of the development of a strip-based tooth whitening system in order to ascertain factors that contribute to clinical safety and tolerability. Methods: Data from 32 different randomized clinical trials were included in the meta-analysis. This inclusive assessment involved study subjects who used flexible polyethylene, whitening strips coated with 5.3-6.5% hydrogen peroxide bleaching gel. Treatment was twice daily for 30 minutes over a 2-3 week period. Safety and tolerability were assessed from examination and interview. A logistic regression model was fitted to identify the risk factors for tooth sensitivity and oral irritation. Results: The analysis included 610 subjects (18-82 years of age) with complete safety and tolerability data. Mild and transient tooth sensitivity (17.9%) and oral irritation (19.7%) represented the most common adverse events associated with treatment. Tooth sensitivity was reported by 13.9% of subjects in the 5.3% group, 19.7% in the 6.0% group and 22.9% in the 6.5% group, with treatments differing significantly (p < 0.05) with respect to tooth sensitivity occurrence. Oral irritation was directionally (p = 0.07) more common among 5.3% strip users, the only group with pre-treatment tooth brushing. Age was a significant (p = 0.0008) effect in the tooth sensitivity model, with older subjects reporting less tooth pain during treatment. Race and gender were not significant contributors. Other adverse events were unremarkable. Only 7 subjects (1% of the population) discontinued treatment early due to adverse events. Conclusion: This meta-analysis further establishes the clinical safety and tolerability of whitening strip use.