7-Day Clinical Trial Comparing Two at-Home Whitening Systems

Objective: A randomized, examiner-blind clinical trial was conducted to evaluate the 7-day clinical effectiveness and tolerability of two self-directed, hydrogen peroxide whitening systems. Methods: 30 healthy adults without hypersensitivity were randomized to one of two marketed whitening systems. Subjects received either a full supply of Aquafresh® White Trays™ (TRAY) or one-half supply of Crest® Whitestrips® Classic (½STRIP) for the 7-day study. Subjects were provided with labeled usage instructions, and both arches were treated at-home and unsupervised. Clinical response was measured from digital images (CIELAB), examination and interview at baseline and end-of-treatment using standard methods. Results: Mean age was 44 years, with 67% female. Groups were balanced (p > 0.42) on pertinent demographic and behavioral parameters and starting L*a*b* tooth color. Relative to baseline, both the TRAY and ½STRIP group experienced significant (p < 0.004) reduction in yellowness (Db*) and increased brightness (DL*). On the maxillary arch, adjusted mean b* (SE) was –1.1 (0.15) for each group, while adjusted mean DL* (SE) was 1.0 (0.20) for each group. For the mandibular arch, adjusted mean Db* (SE) was –0.6 (0.16) for the TRAY group and –1.0 (0.16) for the ½STRIP group, while adjusted mean DL* (SE) was –0.7 (0.16) for the TRAY group and –1.0 (0.16) for the ½STRIP group. Groups did not differ significantly with respect to tooth color. Adverse events (oral irritation and tooth sensitivity) were more common and severe in TRAY compared to ½STRIP, with one subject (in TRAY) discontinuing treatment early “for cause”. Conclusion: In head-to-head testing, use of one-half of a standard box of 6% hydrogen peroxide whitening strips yielded similar whitening with fewer adverse events compared to a 7-day at-home, hydrogen peroxide tray system.