Placebo-controlled Six-month Clinical Trial of 6% Hydrogen Peroxide Whitening Strips

Objective: A randomized, double blind, placebo-controlled clinical trial was conducted to evaluate clinical response following 2-week use of whitening strips. Methods: Balancing for baseline shade, 53 healthy adults were treated with 6% hydrogen peroxide whitening strips or placebo. Strip treatment was twice daily for two weeks. Subjects were evaluated at end-of-treatment, and 3 and 6 months post-treatment. Standard tooth shade measurements were collected from the maxillary anterior teeth by 2 independent examiners. Periodontal health was assessed using standard methods for measuring gingivitis (GI) and plaque (PlI). Results: Between-group comparisons using the Vita Lumin guide demonstrated a highly significant (p < 0.0001), 4.7 shade improvement for the whitening strips at end-of-treatment compared to placebo. This shade improvement persisted throughout the post-treatment period, with the whitening strips exhibiting highly significant (p < 0.0001) 4.5 shade and 4.3 shade improvements relative to placebo at the Month 3 and Month 6 examinations. Except for a modest GI reduction at Month 6 favoring the strips, there were no significant between-group differences in GI or PlI at any time point. Both treatments were well tolerated. Only 4% of whitening strip users had tooth sensitivity and 4% had oral irritation. Conclusion: Two weeks use of 6% hydrogen peroxide whitening strips yielded significant mean shade improvement at end-of-treatment and post-treatment, with a safety profile that was similar to placebo.