In-Office Whitening A Randomized, Parallel-Design Clinical Trial to Assess Tooth Bleaching Efficacy and Safety of Light versus non-Light Activated Chairside Whitening in vivo study Authors: Li Y, Lee S, Kwon S.R., Arambula M, Yang H, Li J, Delaurenti M, Jenkins W, Nelson M, Souza S, Ward M. Data on file, 2012 Objective To characterize the extent to which the safety and efficacy profile of Philips Zoom WhiteSpeed (25% Hydrogen Peroxide) and Ultradent Opalescence Boost PF (40% Hydrogen Peroxide) cosmetic whitening regimens differ immediately following, and at seven and thirty days post bleaching application. Methodology One hundred thirty-five of 394 subjects screened completed an IRB-approved double-blind, randomized, parallel-design clinical trial in a population of healthy adults aged 18-75. Fifty-nine subjects were female, 76 were male; with a mean age of 50.0 years. Eligible subjects had a minimum of four maxillary anterior teeth with a tooth shade of A3 or darker assessed per VITA Classical (VC) shade guide. Sixty-eight subjects were randomized to Opalescence Boost and 69 to Philips Zoom. Efficacy was assessed by VITA EasyShade for ∆E characterization using a custom jig fabricated for a single anterior site in addition to VC and VITA Bleachedguide 3D-Master (BG) shade assessment. Safety was characterized by subject report of sensitivity, oral examination and subject use of sensitivity-reducing agents (Relief ACP or UltraEZ) applied and dispensed per manufacturer’s instructions. Study endpoints were assessed pre- and post-whitening, at Day 7 and Day 30. Results Median ∆E values per Kruskal-Wallis analysis for instrumental color change immediately post-whitening were 5.12 for Zoom and 2.55 for Boost (p<0.0001). At Day 7, ∆E outcomes were 6.34 for Zoom and 4.08 for Boost (p=0.0059). At Day 30, ∆E outcomes were 6.03 for Zoom and 3.44 for Boost (p=0.0019). The difference between treatments at each timepoint was statistically significant. For VC visual shade assessment, LS Mean (SE) based on analysis of variance immediately post-whitening values were 5.86 (0.18) for Zoom and 4.47 (0.18) for Boost (p<0.0001). At Day 7, outcomes were 4.92 (0.20) for Zoom and 4.19 (0.20) for Boost (p=0.0106). At Day 30, outcomes were 4.45 for Zoom and 4.11 for Boost (p=0.2648). For BG visual shade assessment, the median shade change per Kruskal-Wallis analysis immediately post-whitening was 3.17 for Zoom and 2.00 for Boost (p<0.0001). At Day 7, outcomes were 2.33 for Zoom and 1.67 for Boost (p=0.0198) and at Day 30, outcomes were 2.25 for Zoom and 1.83 for Boost (p=0.1195). The percentage of subjects who reported ‘No Sensitivity’ immediately post-whitening was 98.5% for Zoom and 98.6% for IN-OFFICE WHITENING A Randomized, Parallel-Design Clinical Trial to Assess Tooth Bleaching Efficacy and Safety of Light versus non-Light Activated Chairside Whitening

A Randomized, Parallel-Design Clinical Trial to Assess Tooth Bleaching Efficacy and Safety of Light versus non-Light Activated Chairside Whitening Boost. At Day 7, subject-reported values for ‘No Sensitivity’ were 82.1% for Zoom and 79.4% for Boost. Of those experiencing sensitivity, one subject rated sensitivity as ‘Moderate.’ All other reports were characterized as ‘Mild’ by subjects. There were a total of 41 adverse events reported among 34 subjects. In general, these events were associated with sensitivity. Subject use of post-whitening sensitivity gel (Relief ACP and UltraEZ) was low. Four...

A Randomized, Parallel-Design Clinical Trial to AssessTooth Bleaching Efficacy and Safety of Light versus non-Light Activated Chairside Whitening Median AL Post Whitening | Zoom WhiteSpeed | Opalescence Boost IN-OFFICE WHITENING

A Randomized, Parallel-Design ClinicalTrial to AssessTooth Bleaching Efficacy and Safety of Light versus non-LightActivated Chairside Whitening Median Ab Post Whitening | Zoom WhiteSpeed | Opalescence Boost LSMeansVITA Classical Shade Reduction Post Whitening | Zoom WhiteSpeed | Opalescence Boost IN-OFFICE WHITENING

A Randomized, Parallel-Design Clinical Trial to Assess Tooth Bleaching Efficacy and Safety of Light versus non-Light Activated Chairside Whitening Median VITA Bleached Guide Shade Reduction Post Whitening Day 7 and Day 30 3.5 Zoom WhiteSpeed Opalescence Boost Maximum Sensitivity Experienced from Whitening Treatment 120% 100% 90% Zoom WhiteSpeed Opalescence Boost Moderate Sensitivity IN-OFFICE WHITENING Mild Sensitivity In-Office Whitening