27 Vol. 25, No. 8 (Suppl 2) Compendium / August 2004 Abstract: This clinical trial tested the efficacy and safety of a profes- sional strip-based whitening system (Crest Whitestrips ® Supreme) using the manufacturer’s recommended 3-week treatment regimen. These strips have a higher concentration, but a similar amount of hydrogen per- oxide relative to Crest ® Professional Whitestrips ™ , because the thickness of the gel on strips is reduced. Tooth whitening was measured using the value-oriented VITA ® Classic Shade Guide before and after treatment. Twenty-nine subjects were treated with either Crest Whitestrips ® Supreme or placebo strips that did not contain hydrogen peroxide. Participants in the experimental group achieved a mean lightening of nearly eight VITA ® shades relative to placebo, with minimal side effects. H aywood and Heymann formally introduced at-home bleaching to the dental profession in 1989. 1 Since then, at-home bleaching using carbamide peroxide and, more recently, hydrogen peroxide has become a popular method for lightening discolored teeth. 2 Although some clinicians were concerned initially about potential problems related to self-administered bleaching treatments, the safety and efficacy of dentist- prescribed, patient-applied, peroxide bleaching agents have been evaluated and verified in numerous clinical trials. 3-20 Several of these clinical trials were conducted according to guidelines first published by the American Dental Association’s (ADA) Council on Dental Therapeutics (now called the Council on Scientific Affairs) in 1994 and revised in 1998. 21,22 Until recently, dentist-prescribed, patient-applied, peroxide bleaching agents used a gel or paste that was applied to the teeth in custom-fitted trays. However, in 2000, The Procter & Gamble Company introduced a novel trayless system called Crest Whitestrips ®,a , in which a measured dose of hydrogen-peroxide gel is applied to the anterior teeth using an embossed polyethylene strip. 23-29 Whitestrips currently are available in two over-the- counter (OTC) and two professional versions. The OTC versions are a 2- week kit (6% hydrogen-peroxide strips) and a newer 1-week kit (10% hydrogen-peroxide strips). Both professional kits contain a 3-week supply of strips, with one being 6.5% hydrogen peroxide, and the newer one con- taining strips with 14% hydrogen peroxide. Although the newer profes- sional version contains 14% hydrogen peroxide, the gel has a reduced film thickness, and thus delivers an amount of peroxide similar to the original professional strips (14 mg vs 13 mg on the maxillary strips). The purpose of this randomized, blinded clinical study was to evaluate the safety and effectiveness of the 14% hydrogen-peroxide Crest Whitestrips ® Supreme a for bleaching discolored maxillary anterior teeth relative to a placebo. Because many dentists use shade tabs to communicate color changes to their patients, this study used the VITA ®,b Classic Shade Guide to assess efficacy. Side effects were monitored using participant inter- Three-Week Clinical Trial of a 14% Hydrogen-Peroxide, Strip- Based Bleaching System a The Procter & Gamble Company, Cincinnati, OH 45202; 800-492-7378 b Vita Zahnfabrik, Germany; distributed in US by Vident™, Brea, CA 92621; 800-828-3839 Edward J. Swift, Jr, DMD, MS Professor and Chair Department of Operative Dentistry Patricia A. Miguez, DDS, MS Graduate Student Department of Oral Biology University of North Carolina Chapel Hill, North Carolina Matthew L. Barker, PhD Senior Statistician Biometrics & Statistical Sciences Robert W. Gerlach, DDS, MPH Principal Scientist Worldwide Clinical Investigations—Oral The Procter & Gamble Company Mason, Ohio After reading this article, the reader should be able to: • describe the degree of shade change that can be achieved using a strip-applied, 14% hydrogen-peroxide bleaching product. • discuss the incidence of side effects associat- ed with this material relative to a placebo. • explain why the inci- dence of side effects seen with the 14% hydrogen-peroxide strip product was relatively low. Learning Objectives CE 4