Objective: Subjects in a placebo-controlled clinical trial were evaluated at end-of-treatment, and again, one year after completion of treatment to ascertain efficacy and safety of 10% hydrogen peroxide whitening strips. Methods: 39 subjects were randomized to Crest® Whitestrips® Premium, a 10% hydrogen peroxide whitening strip or placebo. Treatment was twice daily for 7 days, at-home and unsupervised. Subjects in the 10% strip group were re-evaluated at 12-months post-treatment to ascertain long-term color change, and clinical safety. Efficacy was measured objectively as L*a*b* color change from digital images at end-of-treatment and post-treatment. Results: For the 12-month recall subjects in the 10% strip group, end-of-treatment mean (SD) Δb* was –2.5 (1.02), and mean ΔL* (SD) was 2.5 (0.91). This 10% strip group experienced significant (p <0.0001) end-of-treatment color improvement (Δb* & ΔL*) relative to baseline and placebo. At 12-months post-treatment, the 10% strip group had mean (SD) Δb* of –1.9 (1.00), and mean ΔL* (SD) of 2.2 (0.90). Treatment differed significantly (p <0.0001) from baseline for both Δb* and ΔL*. Mild tooth sensitivity and oral irritation, the most common side effects in the study, resolved during treatment or post-treatment. No subjects discontinued treatment early due to an adverse event, and there were no post-treatment findings except for whitening. Conclusion: This clinical trial demonstrated 12-month post-treatment safety and long-term whitening following twice daily use of a 10% hydrogen peroxide strip.

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