Method: Institutional review and informed consent were obtained, and subjects with no previous history of teeth whitening were randomly assigned to high-adhesion 10% H2O2 tooth whitening strips (Crest® 3D White Whitestripsâ Professional Effects) or placebo strips without peroxide. Test strips plus a regular paste and brush were dispensed in blinded packaging with instructions for one hour daily use on maxillary teeth for ten consecutive days. Tooth color was measured at Baseline, Day 3 and Day 11 from intraoral digital images, and treatments were compared on two-parameter color improvement (Δb* and ΔL*). Safety was assessed by clinical examination and interview.
Result: Forty–one subjects with a mean age (SD) of 33.3 (14.26) completed the study. After two days of treatment (Day 3), subjects using 10% H2O2 strips demonstrated a statistically significant decrease in yellowness (Δb*, p≤ 0.0002) and increase in lightness (ΔL*, p<0.0001) compared to placebo. At Day 11, the high adhesion 10% H2O2 group exhibited an incremental –2.14 Δb*and 2.29 ΔL* versus placebo, differing significantly (p<0.0001) from the control. Strip use was well-tolerated, 5 subjects (3 in the peroxide group 2 in the control) had minor oral irritation, and no subjects discontinued strip use due to adverse events.
Conclusion: A placebo-controlled clinical trial demonstrated that high-adhesion 10% H2O2 whitening strips were well-tolerated, and resulted in significant two-parameter tooth whitening after two days use.