Placebo-controlled, 6-week clinical trial on the safety and efficacy of a low-gel, 14% hydrogen-peroxide whitening strip.
Clinical research was conducted to evaluate the extended-use safety and efficacy of Crest Whitestrips Supreme, a low-gel (100 mg on maxillary strip), 14% hydrogen-peroxide professional tooth-whitening system. The parallel-group study was randomized, double-blind, and placebo-controlled, and involved 39 healthy adults. During the treatment phase, subjects used the investigational products twice daily (for 30 minutes each) for 6 weeks (42 days). Safety and efficacy measurements were obtained at baseline and at the completion of each 3-week treatment period. Results showed that twice-daily use of Crest Whitestrips Supreme for 3 weeks resulted in a highly significant (P < .0001) improvement in tooth color, with a mean yellowness reduction (delta b*) of -3.3 and a mean brightness improvement (delta L*) of 2.4 relative to placebo. Color improvement continued with extended strip use over 6 weeks for all parameters (P < .0005). Relative to placebo at 6 weeks, color improvement was highly significant (P < .0001), with a mean delta b* of -4.1 and a mean delta L* of 3.2. Mild and transient tooth sensitivity and oral irritation were the most common adverse events. There was no evidence of any meaningful increase in adverse events with extended treatment through 6 weeks. Twice-daily use of Crest Whitestrips Supreme resulted in a highly significant improvement in tooth color after 3 weeks, with color improvement continuing over 6 weeks.
García-Godoy
Franklin
F
Bioscience Research Center, The Procter & Gamble Company, Mason, Ohio, USA.
Villalta
Patricia
P
Barker
Matthew L
ML
Gerlach
Robert W
RW
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
C488279:Crest whitestrips; D005782:Gels; D016877:Oxidants; D006861:Hydrogen Peroxide