Objective: This research compared the clinical response of two different peroxide-containing gel formulations delivered using self-applied whitening strips. Methods: A randomized, double-blind clinical trial was conducted to compare a modified hydrogen peroxide bleaching gel with 0.075% sodium saccharin to matched control without saccharin. The bleaching gels were applied to the maxillary anterior dentition twice daily using thin polyethylene strips. Efficacy (L*a*b* color change) was measured objectively by digital image analysis. Results: A total of 23 adults ranging from 23-57 years of age participated in the research. Both treatments were effective in whitening teeth, as evidenced by a statistically significant improvement from baseline (p < 0.0005). After adjusting for age and baseline color, mean Db* (SE) for the modified formula was –2.37 (0.180) compared to –1.95 (0.200) for the matched formula. While the modified formula had 21% greater whitening (Db*), the treatments did not differ significantly (two-sided p-value = 0.147). Outcomes for the other color parameters directionally favored the modified formula. Both treatments were well tolerated. Both tooth sensitivity and oral irritation (reported by 27-33% of subjects) were mild in severity, and no subjects discontinued treatment due to bleaching-related adverse events. Conclusion: For whitening strips, this research demonstrates that the clinical response was similar between a modified 6% hydrogen peroxide bleaching gel with sodium saccharin and the matched control without saccharin.

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