0120 Subject-level Meta-analysis of Clinical Studies Comparing Two Marketed Whitening Strips
S. FARRELL, M.L. BARKER, M.K. ANASTASIA, P.A. SAGEL, and R.W. GERLACH, The Procter & Gamble Company, Mason, OH, USA

Objective: This research was conducted to systematically evaluate the clinical effectiveness of two peroxide-based, direct-to-consumer whitening strip-based systems. Methods: A meta-analysis was conducted using an inclusive dataset from four randomized clinical trials that had common control, entrance criteria and methods. In each study, one of Oral-B® Rembrandt® whitening products – 5-day strips (Rmb5), 7-day Premium strips (Rmb7) or 7-day Professional strips (Rmb7Pro) – was compared to a positive control – Crest® Whitestrips Premium (CWSP) containing 10% hydrogen peroxide. Per manufacturer's recommendations, Rmb5, Rmb7 and Rmb7Pro were used 30 min daily for 5, 7 and 7 days, respectively and CWSP were used 30 min twice daily for 7 days. Effectiveness was measured objectively as L*a*b* color change using digital image analysis. Comparative efficacy was evaluated using a mixed model that adjusted for study, age and baseline color. Results: The pooled sample included 207 subjects (18-67 years of age). At the end of treatment, adjusted mean (SE) Δb* (yellowness reduction) was –1.9 (0.12), –0.9 (0.15), –1.1 (0.19), and –0.6 (0.21) for CWSP, Rmb5, Rmb7 and Rmb7Pro, respectively. The adjusted mean (SE) end-of-treatment ΔL* (lightness improvement) was 1.9 (0.07), 0.9 (0.10), 1.3 (0.13), and 1.3 (0.14) for CWSP, Rmb5, Rmb7 and Rmb7Pro strips, respectively. Use of CWSP resulted in significantly (p < 0.001) greater tooth color improvement relative to any of the other strips. The three Rmb strip products did not differ significantly with respect to both Δb* and ΔL*. Conclusion: This meta-analysis demonstrated that marketed 10% hydrogen peroxide whitening strips provide significantly greater tooth whitening response relative to tested Rmb strip variants.

Seq #31 - Clinical Trials: Whitening Agents, Dentifrices and Desensitizers 1
9:00 AM-10:30 AM, Thursday, March 22, 2007 Ernest N. Morial Convention Center 393

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