1372 Clinical Evaluation of 14% Hydrogen Peroxide Strips Relative to Placebo
F. GARCIA-GODOY1, P. VILLALTA1, C. GARCIA-GODOY1, L.A. BOWMAN2, M.L. BARKER2, and R.W. GERLACH2, 1Nova Southeastern University, Fort Lauderdale, FL, USA, 2The Procter & Gamble Company, Mason, OH, USA

Objectives: A clinical trial was conducted to evaluate the clinical effectiveness and tolerability of a professionally-dispensed 14% hydrogen peroxide whitening strip relative to a placebo control. Methods: 26 adults were randomized to Crest® Whitestrips® Supreme, a 14% hydrogen peroxide whitening strip or placebo strip balancing for age and baseline tooth color. In this 3-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 22. Results: As early as Day 4, the 14% strip group experienced significant (p < 0.005) color improvement relative to baseline and placebo for all color parameters. After 3-days use, the adjusted Δb* means (SE) were –1.39 (0.16) and 0.03 (0.17) for the peroxide and placebo groups, respectively. The peroxide group experienced significant (p < 0.0001) additional whitening (Δb* & ΔL*) during the Day 4 to Day 22 period. After 3 weeks of treatment, the adjusted Δb* mean (SE) was –3.82 (0.32) in the 14% strip group compared to –0.01 (0.38) in the placebo group. Similar results were noted for ΔL*, with an adjusted mean (SE) treatment difference of 2.9 (0.29) for the 14% strip group relative to placebo. Between group comparisons demonstrated highly significant (p <0.0001) color improvement for the 14% strip versus placebo for all color parameters. Tooth sensitivity and oral irritation, the most common adverse events, were mild in severity. Conclusion: This placebo-controlled clinical trial demonstrated that a professionally-dispensed 14% hydrogen peroxide strip yielded significant tooth whitening with no subjects discontinuing treatment due to an adverse event.

Seq #160 - Tooth Whitening
3:00 PM-4:00 PM, Friday, 10 March 2006 Dolphin Hotel Pacific Hall

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