The efficacy and safety of a 10% carbamide peroxide bleaching gel.
OBJECTIVE
A 6-month, double-blind study was undertaken to assess the efficacy and safety of a 10% carbamide peroxide gel designed for at-home tooth bleaching.


METHODS
Sixty patients were randomized into two equal subgroups balanced by age, gender, and oral health status. Shade guide measurements, color transparency photographs, and colorimeter readings were taken and evaluated at baseline and 1, 2, 3, 6, 12, and 24 weeks. The active phase of treatment lasted 14 days.


RESULTS
At 22 weeks postbleaching (week 24 of the study), patients receiving the active agent had a 14.1 rank order difference in the shade guide from baseline, and 66% had a clinically observable color change as determined by photographic assessment. They also had a measurable, statistically significant color change from baseline to 6 months of delta E* = 5.0. The tooth color of maxillary incisors stabilized at week 6 and maxillary canines at week 12. The mean color change lost from weeks 2 to 24 was 45% (in delta E*). Transient tissue and tooth sensitivity, noted in some patients, resolved after treatment was completed.


CONCLUSIONS
The product tested is an effective and safe tooth-whitening agent.
Matis
B A
BA
Department of Restorative Dentistry, Indiana University, School of Dentistry, Indianapolis 46202-5186, USA. BMatis@iusd.iupui.edu
Cochran
M A
MA
Eckert
G
G
Carlson
T J
TJ
D000328:Adult; D000704:Analysis of Variance; D000077463:Carbamide Peroxide; D016009:Chi-Square Distribution; D003124:Colorimetry; D003481:Cuspid / Q000737:chemistry; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005782:Gels / Q000627:therapeutic use; D006801:Humans; D007180:Incisor / Q000737:chemistry; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010512:Periodontal Index; D010545:Peroxides / Q000627:therapeutic use*; D014073:Tooth Bleaching / Q000379:methods*; D014075:Tooth Discoloration / Q000628:therapy*; D014508:Urea / Q000031:analogs & derivatives* / Q000627:therapeutic use
D004338:Drug Combinations; D005782:Gels; D010545:Peroxides; D000077463:Carbamide Peroxide; D014508:Urea