3210 Subject-Level Meta-Analysis of Clinical Effectiveness for Direct-to-Consumer Vital Bleaching Products
M.L. BARKER, The Procter & Gamble Co, Mason, OH, USA, and R.W. GERLACH, The Procter & Gamble Co, Mason, OH, USA

Objectives: Despite the growth in direct-to-consumer bleaching, only a few systems have been evaluated in well-controlled clinical trials. This research was conducted to systematically evaluate the clinical effectiveness of 10 peroxide-based, direct-to-consumer whitening systems. Methods: A meta-analysis was conducted using an inclusive dataset from 19 randomized clinical trials that had common entrance criteria and methods. Each study evaluated a direct-to-consumer, peroxide-based tooth whitening system, with common strip/paint-on systems as controls. 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 724 subjects (18-75 years of age) who used direct-to-consumer products for periods up to 14 days. The two strip systems (6% strips for 2 weeks & 10% strips for 1 week) yielded the greatest color improvement. At the respective end-of-treatment periods, adjusted mean (SE) Db* was –2.22 (0.07) and –2.21 (0.21), and adjusted mean (SE) DL* was 1.89 (0.08) and 1.90 (0.24) for the 6% & 10% strips, respectively. Response with the five stock tray systems was variable, with adjusted Db* means ranging from–0.02 (0.75% hydrogen peroxide) to –1.02 (10% carbamide peroxide). Response with the three paint-on systems was also variable, with adjusted Db* means ranging from –0.26 (hydrogen peroxide paint-on) to –0.99 (19% sodium percarbonate film). Both strip groups exhibited significantly (p < 0.05) greater whitening (Db*, DL*, DE* & DW*) compared to the other self-directed products. Conclusion: Whitening response with direct-to-consumer whitening products varied between products, with the two strip systems exhibiting superior and meaningful whitening relative to other tray and paint-on products.

Seq #341 - Tooth Whitening
10:15 AM-11:30 AM, Saturday, 13 March 2004 Hawaii Convention Center Exhibit Hall 1-2

Back to the Dental Materials: IV - Clinical Trials Program
Back to the IADR/AADR/CADR 82nd General Session (March 10-13, 2004)

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