Objective: This research compared the clinical efficacy and safety of two different brush-applied whitening products used overnight for 2 weeks. Methods: A pooled, 2-study, subject-level analysis compared clinical response in 103 subjects who were randomized to Colgate® Simply White Night^TM (a hydrogen peroxide paint-on gel) or Crest® Night Effects^TM (a 19% sodium percarbonate film). Study participants were supplied with the manufacturers written instructions for use, treatment was at-home overnight, and all usage was unsupervised. Effectiveness was measured objectively as L*a*b* color change using digital image analysis. Comparative efficacy was evaluated using ANCOVA adjusting for study, age and baseline color. Subjects were interviewed for oral discomfort after 2 weeks use. Results: Study subjects ranged in age from 18 to 61 years. After 2 weeks use, adjusted means and standard errors for Db* (yellowness reduction) were –1.02 ± 0.08 for the sodium percarbonate bleaching film compared to –0.17 ± 0.08 for the hydrogen peroxide paint-on with groups differing significantly with respect to Db* and all other whitening color parameters (p < 0.0005). Efficacy results were consistent in the individual studies, and there were no significant (p > 0.10) study by treatment interactions. Oral irritation was the most common adverse event overall, reported by 15% of the paint-on users, and 2% of film users. No one discontinued use early due to a product-related adverse event. Conclusion: After 2 weeks overnight use, the 19% sodium percarbonate bleaching film provided significant whitening improvement relative to the hydrogen peroxide paint-on gel.

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