Objective: Direct-to-consumer tooth whitening systems use various devices and treatment regimens to deliver peroxide to the tooth surface. This 14-day clinical trial was conducted to evaluate the clinical response of a new “wrap-around” delivery relative to a marketed strip control. Methods: A total of 39 healthy adults were randomized to Rite Aid Whitening Wraparounds™, a hydrogen peroxide tooth “wrap”, or Crest® Whitestrips®, a 6% hydrogen peroxide gel on a whitening strip. Following the manufacturers written instructions for use, the wrap was applied once daily, and the strips were applied twice daily, each for 30 minutes over a 14-day period. Efficacy was measured as L*a*b* color change using digital images of the anterior dentition on Day 15. Subjects were also questioned regarding personal color perception using a linear scale. Results: Adjusting for baseline and age, the Day 15 estimated means (SE) for Δb* (yellowness) were –1.08 (0.15) for the wrap group compared to –1.73 (0.15) for the strip group. Between-group comparisons showed highly significant (p < 0.005) improvement favoring the strip group. Groups also differed significantly with respect to the perceptual parameters relating to whitening improvement (p = 0.030), satisfaction with whitening (p = 0.029), and overall treatment impression (p=0.027). Oral irritation was the most common adverse event in both the wrap (37%) and strip (20%) groups. Conclusion: Use of 6% whitening strips resulted in significant objective and subjective whitening versus a hydrogen peroxide wrap.

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