Evaluation of Whitening Efficacy of a Low-Concentration H₂O₂ Strip

Objectives: The objective of this study was to evaluate whitening efficacy and tolerability of a low H₂O₂ whitening strips relative to a negative control in Chinese population.
Methods: After IRB review, informed consent was obtained from adult volunteers with no prior history of tooth whitening. Balancing for baseline, forty enrolled subjects were randomly assigned to either a 5.25% hydrogen peroxide strips or Crest Cavity Protection toothpaste. All subjects brushed twice daily in the customary manner for the duration of the study. Subjects in the strip group were instructed to use one strip for 30 minutes once daily for 14 consecutive days. Oral safety was assessed by oral status interview and oral examination, and whitening efficacy measured instrumentally as L*a*b* color change from digital images of the maxillary anterior teeth at Baseline, Day 8 and Day 15.
Results: A total of 40 subjects were enrolled, and 39 completed the study. Mean age of subjects was 38.6 years. At Day 8 (the first post-baseline visit) and at Day 15, the strip group exhibited a statistically significant (p≤0.0005) reduction in yellowness (Δb*) and improvement in lightness (ΔL*) relative to baseline. The negative control group had a statistically significant (p=0.03) change in yellowness at Day 8 only. At both Day 8 and Day 15 visits, the use of 5.25% H₂O₂ strips resulted in significantly (≤0.04) greater b* and L* color improvement relative to the negative control. The adjusted mean Δb* values for strips and paste groups were -0.650 and -0.298 , and -0.955 and -0.250 at Day 8 and Day 15, respectively. The adjusted mean ΔL* values for strips and paste groups were 1.00 and 0.193, and 0.854 and 0.091 at Day 8 and Day 15, respectively.


Conclusions: This clinical study demonstrated a significant whitening efficacy of a low-concentration hydrogen peroxide high adhesion whitening strip.