Clinical Comparison of Two Direct-to-Consumer Bleaching Systems

Objective: Several combination whitening systems having various peroxide sources have been introduced for direct-to-consumer whitening. A 2-week clinical trial was conducted to evaluate the clinical effectiveness of one such combination system relative to a marketed control. Methods: In this parallel, examiner-blind, single-center study, 20 healthy adult volunteers were randomized to Mentadent^TM Tooth Whitening, a combination system consisting of a pre-rinse, 0.75% peroxide gel plus and activator paste, stock mouth tray and dosing paddle, or Crest® Whitestrips® 6.0% hydrogen peroxide whitening strips. Study participants were supplied with the manufacturers written instructions for use, only the maxillary arch was treated, and all treatment was unsupervised. Efficacy was measured using L*a*b* color change collected from digital images of the anterior dentitDion. Results: The estimated means and standard deviations for Db* (yellowness) were +0.18 ± 0.344 for the combination group compared to –1.81 ± 1.086 for the strip group. For the primary response variable Db*, the strip group exhibited significant (p = 0.001) improvement from baseline, while the combination group exhibited no significant (p = 0.11) color change. Treatments differed significantly (p < 0.0001) with respect to Db*, and all other color parameters (DL*, Da*, DE*, and DW*) measured in the study. Both treatments were similarly well tolerated, with 2 subjects reporting oral irritation and 1 subject reporting tooth sensitivity in each group. Conclusion: The 6.0% whitening strips resulted in superior whitening, while the combination gel/rinse system failed to exhibit any significant benefit with respect to yellow tooth color.