Safety and Efficacy of Three Experimental Whitening Agents

Objectives: This project investigates the safety and efficacy of three experimental whitening agents. Sensitivity was assessed during active treatment, and the shade of the teeth was evaluated using a shade guide. The hypotheses that there was a significant association between shade and recall period, and that a difference in sensitivity existed between products were tested. Methods: 63 people agreed in writing to participate in this double-blind, randomized clinical trial. There were three groups, EXP1, EXP2 and EXP3. The active ingredient in each was carbamide peroxide 10%. Participants were asked to wear a custom-made, scalloped stent with reservoirs each night for two weeks (>six hours). Exams were performed at baseline, one, two, 13 and 26 weeks. A value-ordered Vita shade guide (C4 = 1 to B1=16) was used to evaluate color, and a daily log was used to record the presence/absence of sensitivity. The number of days participants experienced sensitivity of the teeth or soft tissues was recorded. Sensitivity from multiple sources was additive; e.g., gingival and tooth sensitivity on the same day counted as two days. The final measure was expressed as the percentage of days spent actively whitening. Results: No one reported any sensitivity remaining after the active treatment. For group EXP1, participants experienced sensitivity 24.4% of the days spent actively whitening. For EXP2 and EXP3 it was 9.8% and 25.6% respectively. There was a significant difference between groups (Chi Square; p < 0.001). A significant association was found between the shade and the recall period for all three agents (RMANOVA; p <0.001). Conclusion: For this group of subjects, all three experimental whitening agents proved to be effective. All were shown to be safe, and the level of sensitivity was well within that reported in the literature. Supported by Ultradent Products, Inc.