At-home Bleaching with a Novel Carbamide Peroxide Polymeric Nanoparticle Gel: A Multicenter Randomized Controlled Trial

Abstract

SUMMARY Objectives To compare the risk and intensity of tooth sensitivity (TS) as well the effectiveness of at-home bleaching using two carbamide peroxide bleaching gels, specifically a novel polymeric nanoparticle gel (experimental) and a commercial gel (Opalescence PF, Ultradent, South Jordan, Utah, USA), applied at two application times. Methods This multicenter, triple-blind, and split-mouth randomized controlled trial was conducted on 80 healthy adults with canine teeth that were shade A2 or darker. The participants all used the experimental and the control gels on one side of a tray, depending on the group to which they were allocated, for 30 or 60 minutes per day over four weeks. The absolute risk and intensity of TS were assessed daily using the five-point Numeric Rating Scale and the 0–10 Visual Analogue Scale. Color change was evaluated with shade guide units (ΔSGU) and a digital spectrophotometer (ΔEab, ΔE00, and ΔWid) at baseline and 30 days postbleaching. The risk and intensity of TS was evaluated by the McNemar and the Wilcoxon signed-rank tests, respectively. Color change (ΔSGU, ΔEab, ΔE00, and ΔWid) was evaluated by Mann–Whitney and paired t-tests (α=0.05). Results No differences in the risk and intensity of TS were observed based on the bleaching gels used and the times of application (p>0.05). Thirty days after bleaching, there was no significant difference in color change, in terms of the bleaching gels used or the application times (p>0.05). Conclusion The novel carbamide peroxide polymeric nanoparticles gel, when applied for 30 or 60 minutes, produced effective color change and a low rate of tooth sensitivity, as compared to the control group.