Clinical evaluation of a 3% hydrogen peroxide tooth-whitening gel.
OBJECTIVE
The purpose of this randomized double-blind investigation was to clinically evaluate the effectiveness of a commercially available 3% hydrogen peroxide tooth-whitening material (ADS Tooth Whitening Gel, Applied Dental Sciences, Inc., Lee, MA). The material was used over 2 weeks in a dentist-supervised, patient-applied application.


METHODS
The evaluation was carried out in accordance with American Dental Association (ADA) Council on Scientific Affairs Acceptance Program Guidelines for Home-Use Tooth Whitening Products (May 1998). Sixty-five participants were randomized into two groups (active and placebo) for a double-blind, placebo-controlled study. A custom application tray, scalloped without reservoirs, was fabricated for each participant. Tooth shades were documented by matching with the Vita shade guide ordered according to value and assigned a numeric ranking from 1 to 16, darkest to lightest. Participants were supplied with the treatment solutions to use in the application tray. Duration of active treatment was 30 minutes 3 times a day for 2 weeks. Participants were evaluated at baseline, 1 week and 2 weeks treatment, and 12 and 26 weeks post-treatment. The statistical analysis used at each time point to determine the difference between the active and placebo groups based on the change in value was the two-sample t-test. Plaque and soft tissue indices were also recorded.


RESULTS
The teeth treated with 3% hydrogen peroxide were significantly lighter at 2, 12, and 26 weeks (p < or = .0140, .0004, and .0001, respectively) compared with the placebo group. The mean shade change was 4.2 Vita shade tabs at 2 weeks. At 26 weeks (6 months), the degree of whitening was 4.1 tabs.
Myers
Michael L
ML
Department of Oral Rehabilitation, School of Dentistry, Medical College of Georgia, Augusta, Georgia 30912, USA. mmyers@mail.mcg.edu
Browning
William D
WD
Downey
Mary C
MC
Hackman
Steven T
ST
D000328:Adult; D000704:Analysis of Variance; D003116:Color / Q000592:standards; D003742:Dental Devices, Home Care; D003774:Dental Plaque Index; D003807:Dentin Sensitivity / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D006861:Hydrogen Peroxide / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D016877:Oxidants / Q000008:administration & dosage* / Q000009:adverse effects; D010512:Periodontal Index; D011446:Prospective Studies; D014073:Tooth Bleaching / Q000295:instrumentation / Q000379:methods*
D005782:Gels; D016877:Oxidants; D006861:Hydrogen Peroxide