Placebo-Controlled Clinical Trial with Combined Whitening Strips and Dentifrice

Objectives: A clinical study was conducted to evaluate the combined use of hydrogen peroxide whitening strips and a sodium hexametaphosphate whitening dentifrice on tooth color. Methods: A randomized, placebo-controlled clinical study was conducted to evaluate tooth color with a whitening strip-paste combination versus control. The combination group (Crest® Healthy Radiance™) was assigned 10% hydrogen peroxide whitening strips and sodium hexametaphosphate dentifrice, while the control group was assigned a placebo strip (0% hydrogen peroxide) and pyrophosphate whitening dentifrice. Subjects received a manual toothbrush, strip use was 30 minutes once weekly on the maxillary arch, and brushing was twice daily beginning at baseline. Standard digital images were collected over a 3-weeks to assess L*a*b* color change. Results: A total of 57 subjects were randomized, attended all visits, and completed the study. Mean (SD) baseline tooth color was 17.9 (1.1) for b*, and 71.4 (1.4) for L*. Relative to baseline, the combination peroxide strip-dentifrice group exhibited significant (p<0.05) b*L* color improvement beginning at Week 1 and continuing through Week 3. Most (89%) subjects in the peroxide strip-dentifrice group experienced two-parameter (Db* & DL*) color improvement of 1+ unit, with groups differing (p<0.001) on Db*, DL* and Da* at end-of-treatment, favoring the peroxide combination group. Oral irritation (4%) and tooth sensitivity (2%) were uncommon overall. Conclusion: A placebo-controlled clinical trial demonstrated that a combination weekly 10% hydrogen peroxide whitening strip with a daily anticavity sodium hexametaphosphate dentifrice provided significant tooth whitening without meaningful or unexpected adverse events.