| 1792 Clinical Performance of Professional Tray Bleaching Gel with Added ACP | ||
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M. GINIGER1, H. FELIX2, J. MACDONALD2, S. ZIEMBA2, and M. SPAID1, 1Martin Giniger & Company, New York, NY, USA, 2Discus Dental Inc, Culver City, CA, USA Objective: The purpose of this parallel, double-blind, randomized clinical study was to evaluate the clinical efficacy and transient dentinal hypersensitivity associated with the use of a novel, tray-delivered 16.0% carbamide peroxide equivalent (CPE) bleaching gel containing amorphous calcium phosphate (ACP) over a 19-day period. Methods: Balancing for baseline tooth color, age, and gender, 50 healthy adults who met inclusion criterion were assigned either ACP-containing test gel or similar non-ACP containing control gel. Subjects wore a custom tray containing their assigned gel for a minimum of 3 hours daily (or overnight) for 2 weeks. Tooth color, gingival health, and three independent measures of dentinal hypersensitivity (thermal, tactile and self-assessed) were studied. The double-blinded clinical evaluations took place on days 3, 7, 14 and +5-days post-treatment. Results: The ACP test group demonstrated significantly lower (P<0.05) mean thermal sensitivity scores compared to the control group (day 14 = 0.21 vs 0.31 ; day +5 = 0.06 vs 0.18). Tactile sensitivity scores were also substantially lower (P<0.05) than the control group (day 14 = 0.26 vs 0.48 ; day +5 = 0.06 vs 0.19). Furthermore, five-days after the bleaching treatment was completed, twice as many subjects were thermal sensitivity-free (Test=80% vs Control=40% ; P < 0.001) and there was also a significant (P<0.001) percentage difference for tactile sensitivity. T-test showed that both groups demonstrated equivalent whitening ability (Control= - 7.73 shades; Test= -8.12 shades; P > 0.05). Conclusions: This is the first study to show that use of a 16.0% CPE bleaching gel containing ACP is an effective tooth whitener that also reduces the amount of thermal and tactile hypersensitivity felt during and after treatment. Furthermore, five-days after treatment completion, a much greater percentage of persons using the ACP-containing bleaching gel were sensitivity-free compared to those who used the non-ACP control formulation. Funded by Discus Dental Inc. | ||
| Seq #209 - Tooth Whitening 2:00 PM-4:00 PM, Friday, 11 March 2005 Baltimore Convention Center Exhibit Hall E-F | ||
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