Objective: A placebo-controlled clinical trial was conducted to evaluate the clinical effectiveness and tolerability of a 10% hydrogen peroxide whitening strip. Methods: 39 adults were randomized to Crest® Whitestrips® Premium, a 10% hydrogen peroxide whitening strip or placebo strip. In this 1-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 at Day 4 (interim) and Day 8 (end-of-treatment). Results: Relative to placebo, the 10% strip group experienced significant (p < 0.0001) color improvement for all color parameters beginning at the interim (Day 4) examination. After 3-days use, the adjusted Db* means ± standard errors were –1.6 ± 0.10 and –0.3 ± 0.10 for the peroxide and placebo groups, respectively. Similar results were noted for DL*, with adjusted means ± standard errors of 1.7 ± 0.13 in the 10% strip group versus 0.2 ± 0.13 in placebo. The peroxide group experienced significant (p < 0.002) additional whitening (Db* & DL*) during the Day 4-8 period. At the end-of-treatment, adjusted mean Db* was –2.5 ± 0.19 in the 10% strip group compared to –0.3 ± 0.19 in the placebo group. Between group comparisons demonstrated highly significant (p <0.0001) color improvement for the 10% strip versus placebo for all color parameters measured in the study. Occurrence of mild tooth sensitivity (37%) and oral irritation (16%) were the most common side effects seen with the peroxide strips. Conclusion: This placebo-controlled, double blind clinical trial demonstrated that twice daily use of a 10% hydrogen peroxide strip yielded significant tooth whitening within 3 days without meaningful side effects.

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