Clinical evaluation of a new 10% carbamide peroxide tooth-whitening agent.
NUPRO Gold Tooth Whitening System was evaluated for efficacy according to the proposed ADA guidelines for acceptance. Sixty participants with discolored anterior teeth participated in a 14-day, double-blind, clinical trial. The participants were matched for age, gender, and oral health status and were given either a placebo gel without the active agent or the NUPRO Gold active gel, which they wore in a custom-fabricated mouth guard for home use. The shade of each participant's maxillary anterior teeth was evaluated using a value-oriented Vita Lumin Vacuum Shade Guide before the study. The same shade guide was used to determine shade changes. Time of use of the agent and potential side effects, such as tooth and gingival hypersensitivity and tissue irritation, were assessed at all recall examinations and were recorded by participants in daily diaries. The average shade change for the placebo users was less than one shade. The average shade change for the NUPRO Gold users was 6.96 shades. Tooth hypersensitivity varied from none to severe. Tissue irritation was minimal. The results of these evaluations indicate that NUPRO Gold is effective as a tooth-whitening system, when administered properly under the supervision of a dentist, with commonly reported side effects of transient tooth sensitivity and minimal gingival sensitivity. Little or no change in tissue health was noted. This study was supported by Dentsply Preventive Care (York, Pennsylvania).
Barnes
D M
DM
Department of Restorative Dentistry, University of Maryland, Baltimore Dental School, USA.
Kihn
P W
PW
Romberg
E
E
George
D
D
DePaola
L
L
Medina
E
E
D000293:Adolescent; D000328:Adult; D000368:Aged; D000077463:Carbamide Peroxide; D003116:Color; D003481:Cuspid; D003742:Dental Devices, Home Care; D003807:Dentin Sensitivity / Q000209:etiology; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005882:Gingival Diseases / Q000209:etiology; D006801:Humans; D007180:Incisor; D008297:Male; D008437:Maxilla; D008875:Middle Aged; D010545:Peroxides / Q000009:adverse effects / Q000627:therapeutic use*; D014073:Tooth Bleaching / Q000009:adverse effects / Q000379:methods*; D014075:Tooth Discoloration / Q000188:drug therapy*; D014508:Urea / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D004338:Drug Combinations; D010545:Peroxides; D000077463:Carbamide Peroxide; D014508:Urea