Efficacy and Safety of 10% and 16% Carbamide Peroxide Tooth-whitening Gels: A Randomized Clinical Trial

This double-blind randomized clinical trial evaluated the efficacy and safety of two carbamide peroxide concentrations used in at-home vital bleaching. Ninety-two volunteers with a shade mean of C1 or darker for the six maxillary anterior teeth were randomized into two balanced groups (n=46) according to bleaching agent concentration: 10% (CP10) or 16% (CP16) carbamide peroxide. The patients were instructed to use the whitening agent in a tray for two hours once a day for three weeks. Shade evaluations were done with a value-oriented shade guide and a spectrophotometer at baseline and one week post-bleaching (four-week evaluation). Tooth sensitivity was measured daily using a scale ranging from 0 (no sensitivity) to 4 (severe sensitivity). At the end of the study, the volunteers filled out a questionnaire with seven questions aimed to give their opinion about the adopted treatment regimen. Both carbamide peroxide concentrations resulted in significantly lighter teeth at the four-week evaluation compared to the baseline for all color parameters (p<0.0001) and shade median (p<0.001). There was no significant difference between the two groups in terms of shade change difference with either the spectrophotometer (P=0.1) or the shade guide (p=0.7). Also, no statistically significant difference was found in relation to Delta L* (P=0.7), Delta a* and Delta E* (p=0.5). A significant reduction in yellowness (Delta b*) was observed for CP16 compared to CP10 (p=0.05) in crude analysis, which disappeared after controlling for b* parameter at baseline. The group treated with CP16 experienced more tooth sensitivity during the first (P=0.02) and third (P=0.01) weeks of treatment compared to the CP10 group. However, no major difference was observed (p=0.09) when the degree of tooth sensitivity between groups was compared. Both 10% and 16% carbamide peroxide concentrations were equally effective and safe for a three-week at-home tooth-bleaching treatment.