title: Efficacy and safety of 10% and 16% carbamide peroxide tooth-whitening gels: a randomized clinical trial.
abstract: 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 deltaL* (p = 0.7), delta a* and deltaE* (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.
authors.affiliation: Federal University of Pelotas, Pelotas, RS, Brazil.
authors.forename: Sônia Saeger
authors.initials: SS
authors.lastname: Meireles
authors.forename: Sani Silva
authors.initials: SS
authors.lastname: Heckmann
authors.forename: Fedinan Luis
authors.initials: FL
authors.lastname: Leida
authors.forename: Iná da Silva
authors.initials: Ida S
authors.lastname: dos Santos
authors.forename: Alvaro
authors.initials: A
authors.lastname: Della Bona
authors.forename: Flávio Fernando
authors.initials: FF
authors.lastname: Demarco
mesh_terms: D000328:Adult; D000077463:Carbamide Peroxide; D003742:Dental Devices, Home Care; D003807:Dentin Sensitivity / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008297:Male; D016877:Oxidants / Q000008:administration & dosage*; D010545:Peroxides / Q000008:administration & dosage* / Q000009:adverse effects; D013053:Spectrophotometry; D011795:Surveys and Questionnaires; D014073:Tooth Bleaching / Q000379:methods*; D014508:Urea / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D016877:Oxidants; D010545:Peroxides; D000077463:Carbamide Peroxide; D014508:Urea