Clinical evaluation of a novel whitening gel, containing 6% hydrogen peroxide and a standard fluoride toothpaste

Summary Objectives.The aim of this study was to determine the effect on tooth colour (after 1 and 2 weeks use) of a self-applied tooth-whitening gel containing 6% hydrogen peroxide using a novel applicator, compared to a standard fluoride toothpaste. Methods. A 2-week, examiner-blind, stratified, parallel design clinical trial was conducted. Efficacy was measured by comparing the Vita shade scores recorded at baseline and after 1 and 2 weeks of product application. To qualify for the study, subjects were required to have at least one upper incisor/canine tooth measuring Vita shade A3 or darker. All upper incisors/canines of qualifying subjects were evaluated for change in Vita shade irrespective of their level of whiteness at baseline, allowing for the whitening gel to be tested on the full range of Vita tooth shades. One hundred and seventeen subjects were divided into two groups, balanced according to their darkest tooth shade. One group followed a 2-week, twice-daily regimen of brushing with toothpaste followed by the application of the hydrogen peroxide whitening gel. The other group brushed twice daily with toothpaste for 2 weeks. Results. Subjects using the whitening gel showed a statistically significant improvement, ðp , 0:05Þ in mean tooth shade score of 0.75 and 1.02 units after 1 and 2 weeks, compared to baseline. These improvements from baseline were significantly greater than those observed for the toothpaste only group (0.14 and 0.35 units change after 1 and 2 weeks). Conclusions. The self-applied tooth-whitening gel containing 6% hydrogen peroxide has been shown to significantly improve the whiteness of teeth after 1 and 2 weeks of product use, compared to the baseline and the toothpaste only group.