1045 Safety of Vital Bleaching with 6% Hydrogen Peroxide Whitening Strips: Evidence from 18 Clinical Trials

R.W. GERLACH, X. ZHOU, and D.A. MCMILLAN, The Procter & Gamble Company, Mason, OH, USA

Objective: This research summarizes an extensive clinical trials database on 6% hydrogen peroxide strip-based tooth whitening system in order to ascertain factors that contribute to clinical safety and tolerability.

Methods: Data from 18 different randomized clinical trials were included in the meta-analysis. This inclusive assessment involved study subjects who used flexible polyethylene, whitening strips coated with a 6% hydrogen peroxide bleaching gel. Treatment was twice daily for 30 minutes over a 2-week period. Safety and tolerability were assessed from clinical examination and interview. A logistic regression model was used to identify possible risk factors for tooth sensitivity and oral irritation.

Results: The analysis included 316 subjects (18-82 years of age) with complete safety data. Mild and transient tooth sensitivity (18.0%) and oral irritation (17.1%) represented the most common adverse events during treatment. Age was a significant (p = 0.0008) effect in the tooth sensitivity model, with older subjects reporting less tooth pain during treatment. Race and gender were not significant contributors. Other adverse events were unremarkable, and most resolved during the period of active treatment. Over 97% of adverse events were considered to be “mild” in severity, and only 2 subjects (0.6% of the population) discontinued treatment early due to an adverse event.

Conclusion: This meta-analysis further establishes the clinical safety and tolerability of vital bleaching with 6% hydrogen peroxide whitening strips.

Seq #113 - Whitening, Malodor, Fluoride, Chewing Gum 3:45 PM-5:00 PM, Thursday, 26 June 2003 Svenska Massan Exhibition Hall B