Safety evaluation of a novel whitening gel, containing 6% hydrogen peroxide and a commercially available whitening gel containing 18% carbamide peroxide in an exaggerated use clinical study

Summary Objectives. The aim of this study was to compare the effect on oral soft tissue of a self-applied tooth whitening gel containing 6% hydrogen peroxide (Xtra White) with a marketed paint-on whitening gel containing 18% carbamide peroxide (Colgate Simply White) after 2-weeks of using products four times daily. Methods. A 2-week, examiner-blind, stratified, parallel design clinical trial was conducted. Twenty subjects were divided into two groups, balanced according to age and gender. Subjects followed a 2-week, twice-daily regimen of brushing with standard fluoride toothpaste and applied gel product to facial aspects of six upper and six lower incisors/canines, twice in succession with 30 min between applications. Soft tissue examinations were performed on Day 1, before the first application of the test products, and on Day 2, 5, 8 and 15. Results. During the 2-week treatment period, twelve adverse reactions were recorded as potentially attributable to the study products, evenly split between the two test groups. All reports were mild in symptoms and resolved without the need of medical intervention. None of the subjects experiencing an adverse event requested to be withdrawn from the study. Conclusions. Under the exaggerated use conditions of this test, there was no evidence to suggest that either of the whitening gels produced irritation that was building or developing during the course of the study. It is concluded that both products are safe for their intended use.