Safety and efficacy of a nightguard bleaching agent containing sodium fluoride and potassium nitrate.

OBJECTIVES: 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. METHOD AND MATERIALS: 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. CONCLUSION: 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.