Safety and efficacy of a nightguard bleaching agent containing sodium fluoride and potassium nitrate.
OBJECTIVE
Transient sensitivity during bleaching is generally reported to affect 67% of patients. While most people tolerate this sensitivity, some find it impossible to continue treatment. The purpose of this study was to determine the safety and efficacy of an experimental, low-sensitivity bleaching agent.


METHODS
Twenty-two participants bleached for a minimum of 6 hours per night over a 2-week period. The bleaching agent used, Experimental Product E, is a 10% carbamide peroxide gel containing potassium nitrate and sodium fluoride. Evaluations were performed at baseline and 1,2,13, and 26 weeks. Color change was measured using a value-ordered Vita classic shade guide and a colorimeter. Sensitivity of the teeth, gingiva, tongue, and/or throat was measured daily using a patient log.


RESULTS
The median color change after 2 weeks was eight tabs. Approximately 36% reported sensitivity during the active whitening phase of the study. As a group, participants reported sensitivity during 13.7% of the total days spent whitening.


CONCLUSIONS
Experimental Product E was shown to be safe. Participants experienced minor sensitivity during the active bleaching phase only. Experimental Product E was shown to be an effective bleaching agent for the subjects tested in this study.
Browning
William D
WD
Clinical Research, Department of Oral Rehabilitation, School of Dentistry, Medical College of Georgia, Augusta, Georgia, USA. wbrownin@mail.mcg.edu
Chan
Daniel C N
DC
Frazier
Kevin B
KB
Callan
Richard S
RS
Blalock
John S
JS
D000328:Adult; D000704:Analysis of Variance; D000077463:Carbamide Peroxide; D002327:Cariostatic Agents; D003116:Color; D003742:Dental Devices, Home Care / Q000009:adverse effects; D003807:Dentin Sensitivity / Q000209:etiology / Q000517:prevention & control; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D009566:Nitrates; D016877:Oxidants; D010545:Peroxides; D017680:Potassium Compounds; D012449:Safety; D012969:Sodium Fluoride; D014073:Tooth Bleaching / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D014508:Urea / Q000031:analogs & derivatives*
D002327:Cariostatic Agents; D004338:Drug Combinations; D009566:Nitrates; D016877:Oxidants; D010545:Peroxides; D017680:Potassium Compounds; D000077463:Carbamide Peroxide; D014508:Urea; D012969:Sodium Fluoride; C023844:potassium nitrate