1811 10% Hydrogen Peroxide Whitening Strips: Evidence from 8 Clinical Trials

M.L. BARKER, R.A. BAKER, H. SHAHIDI, P.A. SAGEL, and R.W. GERLACH, Procter & Gamble Co, Mason, OH, USA

Objective: This research summarizes an extensive clinical trials database collected as part of the development of a strip-based tooth whitening system in order to ascertain factors that contribute to clinical effectiveness.

Methods: There were 8 different clinical trials in the inclusive analysis. In all these studies, subjects used a flexible polyethylene, whitening strip coated with a thin 10% hydrogen peroxide bleaching gel twice daily for 30 minutes over a 1-week period. Efficacy was measured in a common fashion using digital images of maxillary anterior teeth to objectively determine tooth color change in CIELAB units (b* yellowness, L* lightness, and a* redness).

Results: The analysis included 175 subjects with demographic, effectiveness and safety data. Age and baseline tooth color were positively-correlated. The regression of age on tooth color demonstrated a slope (SE) of 0.043 (0.0091) b* units per year. Tooth color improved over the 7-day usage period. After adjusting for random study effects, the overall mean (SE) ∆b* and ∆L* were –2.0 (0.15) and 1.9 (0.10), respectively, with each differing significantly (p < 0.0001) from baseline. Age and baseline tooth color were significantly (p < 0.002) related to the primary clinical response (∆b*, yellowness). Minor tooth sensitivity (21%) and oral irritation (21%) represented the most common adverse events. Across 8 clinical trials, only 1 subject (0.6%) discontinued use early due to a treatment-related adverse event.

Conclusion: This meta-analysis of 8 randomized clinical trials showed the 10% hydrogen peroxide whitening strips to be safe and effective, with baseline color and age representing significant determinants of whitening effectiveness.

Seq #209 - Tooth Whitening 2:00 PM-4:00 PM, Friday, 11 March 2005 Baltimore Convention Center Exhibit Hall E-F