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.
Clinical Research, Department of Oral Rehabilitation, School of Dentistry, Medical College of Georgia, Augusta, Georgia, USA. wbrownin@mail.mcg.edu
William D
WD
Browning
Daniel C N
DC
Chan
Kevin B
KB
Frazier
Richard S
RS
Callan
John S
JS
Blalock
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