Objective: A placebo-controlled clinical trial was conducted to evaluate shade change, benefit duration, and safety of a 6% hydrogen peroxide whitening strips. Methods: Fifty healthy adults were randomized to whitening strips with 6% hydrogen peroxide or placebo. Strips were worn for 30 minutes two times a day for 4 weeks. After 2 & 4 weeks strip use, and again, at Month 3 & 6 post-treatment, standard tooth shade measurements were collected from the maxillary anterior teeth, and periodontal health was assessed using standard methods for measuring gingivitis (GI) and plaque (PlI). Results: This Mexico City, DF study population had a mean (SD) age of 23.0 (4.2), 70% of whom were female. At Week 2, the strip group exhibited an adjusted mean (SE) shade change of –5.6 (0.45), differing significantly from placebo and baseline (p < 0.0001). At the Week 4 end-of-treatment visit, between group comparisons demonstrated a highly significant (p < 0.0001) –6.7 shade change 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) 6+ mean shade improvement relative to placebo at the Month 3 and Month 6 examinations. There were no significant (p > 0.23) between-group differences in mean GI or PlI scores during the post-treatment period. Both treatments were well tolerated, with no subject discontinuing treatment early due to an adverse event. Conclusion: Use of 6% hydrogen peroxide whitening strips yielded a significant shade improvement beginning at Week 2, and continuing through 6 months post-treatment.

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