Method: After informed consent and baseline, healthy adults with no tooth whitening history were randomly assigned flexible and stretchable 10% hydrogen peroxide strips or a marketed 10% hydrogen peroxide whitening strip (Crest® 3D White Whitestrips® Professional Effects) control. All strips were distributed in blinded foil pouches in a blinded test kit with a regular anticavity dentifrice and toothbrush, and instructions specifying 60 minutes QD application at-home for 14 days. Efficacy was measured objectively as L*a*b* color change using digital images of the maxillary anterior teeth at Baseline, Day 11, and Day 15.
Result: A total of 38 subjects with a mean (SD) age of 26.2 (9.6) years were randomized, 95% of whom completed the study. At Day 11, Δb* means (SD) were –2.7 (1.01) for the flexible and stretchable strip group and –2.7 (0.86) for the control. Continued use yielded additional whitening, with Day 15 Δb* means (SD) of –3.1 (0.92) and –3.1 (1.05) for the novel strip and control groups, respectively. Responses were similar for ΔL*, with both groups exhibiting highly significant (p<0.0001) whitening improvement beginning at Day 11. Adjusting for baseline, groups did not differ (p>0.70) on Δb* or ΔL* at post-baseline timepoints. Both treatments were similarly well tolerated, with mild transient tooth sensitivity and oral irritation representing the most common adverse events.
Conclusion: In a double-blind clinical trial, use of novel, flexible and stretchable 10% hydrogen peroxide whitening strips provided significant whitening with a similar safety response to marketed whitening strip.