title: Clinical trial comparing two daytime hydrogen-peroxide professional vital-bleaching systems.
abstract: A randomized clinical trial was conducted to compare the whitening effectiveness and tolerability of two daytime, professional, hydrogen-peroxide, vital-bleaching systems. Adults who had never bleached their teeth were randomly assigned to use either 14% hydrogen-peroxide whitening strips or a marketed 9.5% hydrogen-peroxide custom-tray-based system. Maxillary arch treatment was twice daily for 30 minutes for 9 to 21 days, depending on the labeled instructions for use. Whitening response was measured objectively as L*a*b* (which represent three-dimensional tooth color from light to dark, green to red, and blue to yellow, respectively) from digital images of the maxillary anterior teeth, while comparative at-home tolerability was assessed from bleaching tolerability severity days (BTSD) scores. A total of 31 participants aged 18 to 64 were evaluated. At the end of treatment, the adjusted mean (standard deviation [SD]) delta b* was -3.35 (0.37) for the strips and -1.67 (0.344) for the trays. Treatments differed significantly (P < .05) with respect to delta b*, as well as to delta L* and delta W* values at the end of treatment. Overall, at-home strip use was better tolerated, especially with respect to oral irritation. BTSD means (SD) were 0.09 (0.25) and 0.38 (0.49), with treatments differing significantly (P = .036), favoring the strips. This comparative research demonstrated that at the end of treatment, the 14% hydrogen-peroxide whitening strips resulted in a superior, twofold reduction in yellowness and better in-use tolerability compared to the 9.5% hydrogen-peroxide custom-tray system.
authors.affiliation: Worldwide Clinical Investigations-Oral, The Procter & Gamble Company, Mason, Ohio, USA.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Gerlach
authors.forename: Xiaojie
authors.initials: X
authors.lastname: Zhou
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D005782:Gels / Q000008:administration & dosage*; D005881:Gingiva / Q000187:drug effects; D006801:Humans; D006861:Hydrogen Peroxide / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008437:Maxilla; D016877:Oxidants / Q000008:administration & dosage* / Q000009:adverse effects; D014073:Tooth Bleaching / Q000009:adverse effects / Q000379:methods*; D014075:Tooth Discoloration / Q000188:drug therapy*; D014098:Toothache / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: C488279:Crest whitestrips; D005782:Gels; D016877:Oxidants; D006861:Hydrogen Peroxide