Clinical evaluation of a 3% hydrogen peroxide tooth-whitening Gel

Purpose: 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. Materials and 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 ≤ .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.