Clinical Evaluation of 10% Hydrogen Peroxide Strips Relative to Placebo

Objectives: A clinical trial was conducted to evaluate the clinical effectiveness and tolerability of a professionally-dispensed 10% hydrogen peroxide whitening strip relative to a placebo control. Methods: 30 adults were randomized to Crest® Whitestrips® Premium, a 10% hydrogen peroxide whitening strip or placebo strip balancing for age and baseline tooth color. 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 and Day 8. Results: As early as Day 4, the 10% strip group experienced significant (p < 0.003) color improvement relative to baseline and placebo for all color parameters. After 3-days use, the adjusted Δb* means (SE) were –1.17 (0.21) and –0.13 (0.22) for the peroxide and placebo groups, respectively. The peroxide group experienced significant (p < 0.01) additional whitening (Δb* & ΔL*) during the Day 4 to Day 8 period. After 1 week of treatment, the adjusted Δb* mean (SE) was –1.99 (0.24) in the 10% strip group compared to –0.03 (0.26) in the placebo group. Similar results were noted for ΔL*, with an adjusted mean (SE) treatment difference of 1.67 (0.34) for the 10% strip group relative to placebo. Between group comparisons demonstrated highly significant (p < 0.0002) color improvement for the 10% strip versus placebo for all color parameters. Tooth sensitivity and oral irritation, the most common adverse events, were generally mild in severity. Conclusion: This placebo-controlled clinical trial demonstrated that a 10% hydrogen peroxide strip yielded significant tooth whitening with no subjects discontinuing treatment due to an adverse event.