Objective: This clinical study was conducted to assess the safety and tolerability of higher concentration professional whitening strip relative to a marketed higher concentration custom tray system. Methods: 60 adults were randomly assigned to one of two professional bleaching systems. The experimental group, a whitening strip with 14% hydrogen peroxide, was used for 30 minutes BID over 21 days. The marketed control was a 20% carbamide peroxide custom tray system used overnight for two weeks. Examinations and interviews were conducted each week to assess adverse events associated with treatment. Results: Tooth sensitivity and oral irritation were the most common adverse events. At end-of-treatment, oral irritation was reported by 27% of strip users and 67% of tray users. 40% of subjects in the strip group had tooth sensitivity compared to 70% in the tray group. Clinical examination showed a higher occurrence of product-related oral irritation in the tray group (63% versus 20%) relative to the strip group. Treatments differed significantly (p < 0.05) with respect to the odds ratios for oral irritation and tooth sensitivity. While most oral discomfort was “mild” in severity with strips, 63% of tray users had moderate or severe adverse events. Subjects in the tray group were 6.3 times more likely to have more severe discomfort compared to those in the strip group (95% CI of the relative risk was 2.1 to 19.2). Conclusion: Use of 14% hydrogen peroxide whitening strips over 21 days resulted in significantly less tooth sensitivity and oral irritation, and lower adverse event severity compared to a 20% carbamide peroxide tray system used for 14 nights.

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