Objective: A randomized controlled trial was conducted to evaluate clinical safety and efficacy of a 13% hydrogen peroxide whitening strip. Methods: Balancing for age and tooth color, 50 adults were randomized to a 13% hydrogen peroxide thin gel whitening strip or a 6% hydrogen peroxide strip (Crest® Whitestrips®), which served as the positive experimental control. In this 2-week, double-blind clinical trial, strips were applied unsupervised to the maxillary teeth twice daily for 30 minutes. Efficacy was measured objectively as L*a*b* color change from digital images after 1 and 2 weeks. Results: Mean (SD) age was 31.7 (12.2) years, 74% were female, and 8% used tobacco daily. Groups did not differ (p > 0.29) on baseline parameters or tooth color. At one week treatment, both groups experienced significant (p < 0.0001) color improvement relative to baseline for all color parameters. Color improvement continued through Week 2. At that end-of-treatment visit, the adjusted Δb* means ± standard errors were –2.7 ± 0.18 and –2.1 ± 0.18 for the 13% and 6% control groups, respectively. Adjusted DL* means ± standard errors were 2.7 ± 0.21 in the 13% strip group versus 2.5 ± 0.21 in the control. Groups differed significantly (p < 0.05) on Db* at Week 1 and Week 2. Tooth sensitivity and oral irritation were the most common adverse events, and no subject discontinued treatment early due to an adverse event. Conclusion: This positive controlled, double blind clinical trial demonstrated that twice daily use of a 13% hydrogen peroxide strip yielded significant tooth whitening after 7 and 14 days without meaningful side effects.

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