0902 Comparative Effectiveness of Two Self-directed Whitening Systems: Outcomes from Three Randomized Clinical Trials
R.W. GERLACH, M.L. BARKER, X. ZHOU, P.A. SAGEL, and S.F. MCCLANAHAN, The Procter & Gamble Company, Mason, OH, USA

Objective: This integrated research was conducted to establish the comparative efficacy of, 6% hydrogen peroxide whitening strips (Crest® Whitestrips®) versus, 18% carbamide perioxide paint-on gel (Colgate® Simply WhiteTM). Methods: A total of three separate clinical trials were conducted, each at a different research center under the direction of a different investigator. Study participants were supplied with the manufacturers written instructions for use, treatment was twice daily for 30 minutes, and all usage was unsupervised over a 14-day period. Whitening was measured objectively on the maxillary teeth via digital image analysis using well-established and standard methods for L*a*b* color change. Results: A total of 97 healthy adults were randomized to whitening strips or the paint-on gel in these three trials. Outcomes from each of the three clinical trials were consistent, showing highly significant (p < 0.0001) greater color improvement for the strip group for individual (Db*, DL*) color parameters compared to the paint-on gel. The 3-study mean improvement in Db* was 2.57 for whitening strips compared to 0.39 for the paint-on gel. Similar findings were noted for DL*, with the strips exhibiting a 3-study mean improvement of 2.13 compared to 0.30 for the paint-on product. For these primary and secondary color outcomes, whitening strip users experienced approximately a 6.7-fold reduction in yellowness (Db*) and a 7.2-fold increase in brightness (DL*) relative to the paint-on gel. Both treatments were well tolerated over the 14-day treatment period. Conclusion: Outcomes from three randomized clinical trials demonstrate a highly significant, more than six-fold superior whitening benefit for 6% hydrogen peroxide whitening strips compared to the 18% carbamide peroxide paint-on gel.

Seq #101 - Clinical Evaluations of Bleaching/Tooth Whitening
3:45 PM-5:00 PM, Thursday, 26 June 2003 Svenska Massan Exhibition Hall B

Back to the Dental Materials: IV - Clinical Trials Program
Back to the 81st General Session of the International Association for Dental Research (June 25-28, 2003)

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