1371 18-Month Post-Treatment Safety and Efficacy of 10% Hydrogen Peroxide Strips
I. MAGNUSSON1, K. KARPINIA1, P. HARRIS1, M.K. ANASTASIA2, M.L. BARKER2, and R.W. GERLACH2, 1University of Florida -, Gainesville, USA, 2The Procter & Gamble Company, Mason, OH, USA

Objectives: Subjects from two placebo-controlled clinical trials were evaluated at end-of-treatment as well as 18 months after completion of treatment to ascertain efficacy and safety of 10% hydrogen peroxide whitening strips. Methods: A pooled analysis of two placebo-controlled studies at a single center investigated the 18-month post-treatment efficacy and safety of Crest® Whitestrips® Premium, a 10% hydrogen peroxide whitening strip. Treatment on the maxillary teeth was 30 minutes twice daily for 7 days, at-home and unsupervised. Subjects in the 10% strip group were re-evaluated at 18-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: A total of 75 adults with a mean age of 32 years participated in the research. For the recall subjects (N=37) in the 10% strip group, end-of-treatment mean (SD) Db* was –2.3 (0.89), and mean DL* (SD) was 2.1 (0.82). The 10% strip groups experienced significant (p < 0.0001) end-of-treatment color improvement (Db* & DL*) relative to baseline and placebo. At 18-months post-treatment, the 10% strip group had mean (SD) Db* of –1.5 (1.20), and mean DL* (SD) of 1.8 (1.12), differing significantly (p < 0.0001) from baseline for both Db* and DL*. 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 safety findings. Conclusion: This clinical trial demonstrated 18-month post-treatment safety and long-term whitening following twice daily use of a 10% hydrogen peroxide strip.

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

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