Clinical Evaluation of Dissolving Whitening Strips and a Marketed Control

Objective: This randomized, parallel, single-blinded clinical research was conducted to evaluate the efficacy and safety of new dissolving whitening strips relative to a positive control. Methods: Seventy subjects were enrolled in the study and randomly assigned to one of the two treatments: Listerine Whitening® Quick Dissolving Strips worn twice daily until dissolved for 14 days (14-day strips) or 10% H2O2 Crest® Whitestrips® Premium Plus worn 30 min twice daily for 10 days (10-day control strips). Digital images of maxillary teeth were taken at Baseline, Days 11 and 15. Efficacy was assessed as L*a*b* color change from baseline at each visit. Results: Subjects ranged from 18 to 83 years of age, 71% were females. Both groups were balanced with respect to Baseline tooth color (p > 0.7). Both strip groups demonstrated significant (p < 0.0001) color improvement for yellowness (Δb*) and lightness/brightness (ΔL*) relative to Baseline. At each visit, use of the 10-day control strip resulted in significantly (p < 0.02) greater improvement of Δb* and ΔL* compared to that of the 14-day strips. The end-of-treatment comparisons (Day 11 for the 10-day control strips vs. Day 15 for the 14-day strips) also showed significantly (p < 0.0005) greater whitening by the 10-day strips. The end-of-treatment adjusted Δb* means ± standard errors were –1.49 ± 0.14 and –2.21 ± 0.14 for the 14-day and the 10-day strips, respectively. The adjusted ΔL* means ± standard errors were 1.12 ± 0.14 and 1.96 ± 0.14 for the 14-day and the 10-day regimen, respectively. Both products were well-tolerated. Conclusion: Use of the 10% H2O2 marketed control whitening strips resulted in a greater tooth color improvement compared to that of the new dissolving whitening strips.