Efficacy and safety of 10% and 16% carbamide peroxide tooth-whitening gels: a randomized clinical trial

Oper Dent. 2008 Nov-Dec;33(6):606-12. doi: 10.2341/07-150.

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Carbamide Peroxide
  • Dental Devices, Home Care
  • Dentin Sensitivity / chemically induced
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Combinations
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Humans
  • Male
  • Oxidants / administration & dosage*
  • Peroxides / administration & dosage*
  • Peroxides / adverse effects
  • Spectrophotometry
  • Surveys and Questionnaires
  • Tooth Bleaching / methods*
  • Urea / administration & dosage
  • Urea / adverse effects
  • Urea / analogs & derivatives*
  • Young Adult

Substances

  • Drug Combinations
  • Oxidants
  • Peroxides
  • Carbamide Peroxide
  • Urea