title: Safety issues when using a 16% carbamide peroxide whitening solution.
abstract: BACKGROUND
  The scientific literature is lacking on the occurrence of side effects and other safety issues when using carbamide peroxide whitening solutions of concentrations greater than 10%. This double-blind nightguard vital bleaching study compares safety issues when using 16% carbamide peroxide against a placebo or 10% carbamide peroxide (Nite White Classic by Discus Dental Inc.). Evaluated were changes in gingival index, plaque index, nonmarginal gingival index, nongingival oral mucosal index, tooth vitality, and the patients' perceptions of tooth sensitivity and gingival irritation.
  
  
  METHODS
  Twenty female dental hygiene students participated in the study. Each participant wore a maxillary treatment tray for 1 week without any solution and then for 8 to 10 hours per night for 14 nights, filling each quadrant with placebo, 10% carbamide peroxide, or 16% carbamide peroxide, using a split tray design.
  
  
  RESULTS
  With respect to gingival index, plaque index, nonmarginal gingival index, nongingival oral mucosa index, tooth vitality, and tooth sensitivity, there were no statistically significant differences between the 16% carbamide peroxide solution and the other two solutions (p > .05). Quadrants receiving the 16% carbamide peroxide solution experienced more gingival irritation than quadrants receiving placebo or 10% carbamide peroxide solution (p > .05).
  
  
  CONCLUSIONS
  When evaluating the above-mentioned safety issues, except for gingival irritation, there were no statistically significant differences between a 16% carbamide peroxide solution and 10% carbamide peroxide solution or a placebo when used as described here.
  
  
  CONCLUSIONS
  Among the 20 participants whose data were analyzed, it was found that a 16% carbamide peroxide whitening solution (Nite White Classic), when used as described in this study, can be effective in nightguard vital bleaching with no statistical differences in gingival index, plaque index, nonmarginal gingival index, nongingival oral mucosa changes, tooth vitality, or tooth sensitivity, compared with a 10% whitening solution (Nite White Classic). More gingival irritation was experienced with 16% carbamide peroxide. Additionally, 20% of the participants in this study self-reported sensitivity when wearing their treatment tray without any solution, and 36% of the participants reported sensitivity to the placebo solution.
authors.affiliation: Department of Diagnostic Sciences and General Dentistry, University of North Carolina School of Dentistry, Chapel Hill, North Carolina 27599-7450, USA. Ralph_Leonard@dentistry.unc.edu
authors.forename: Ralph H
authors.initials: RH
authors.lastname: Leonard
authors.forename: Glenn E
authors.initials: GE
authors.lastname: Garland
authors.forename: James C
authors.initials: JC
authors.lastname: Eagle
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Caplan
mesh_terms: D000328:Adult; D000077463:Carbamide Peroxide; D016009:Chi-Square Distribution; D003774:Dental Plaque Index; D003782:Dental Pulp / Q000187:drug effects; D003807:Dentin Sensitivity / Q000139:chemically induced; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005881:Gingiva / Q000187:drug effects; D005891:Gingivitis / Q000139:chemically induced; D006801:Humans; D009061:Mouth Mucosa / Q000187:drug effects; D016877:Oxidants / Q000008:administration & dosage*; D010512:Periodontal Index; D010545:Peroxides / Q000008:administration & dosage*; D010919:Placebos; D012449:Safety; D013223:Statistics as Topic; D014073:Tooth Bleaching / Q000379:methods*; D014508:Urea / Q000008:administration & dosage* / Q000031:analogs & derivatives
chemical_list: D004338:Drug Combinations; D016877:Oxidants; D010545:Peroxides; D010919:Placebos; D000077463:Carbamide Peroxide; D014508:Urea