Evaluating the Efficiency and Tooth Sensitivity of a Novel Whitening Strip: A Randomized, Double-Blind Controlled Trial

Abstract

Objective: This randomized controlled clinical trial was to evaluate the tooth whitening efficacy and tooth sensitivity of a novel whitening strips with 3% hydrogen peroxide and 1.5% potassium nitrate. Materials and Methods: Ninety six participants were randomly assigned into two groups: an experimental group using LESENING Whitening Strips with 3% hydrogen peroxide and 1.5% potassium nitrate (n = 41), and the control group using Crest 3D Whitestrips only with 3% hydrogen peroxide (n = 41). Participants attached whitening strips to the teeth' buccal surface for 30 min once daily at home for 28 days continuously. Tooth sensitivity was evaluated using the Schiff score. Tooth color and color change were assessed using a spectrophotometer (CIELAB coordinates L*, a*, b*, ΔE*ab, and dental whiteness index ΔWID) and shade guides (Vita Classical ΔSGU and Vita Bleachedguide ΔSGU), with measurements made at baseline and after 7, 14, 21, and 28 days' use. Levene test, repeated measures ANOVA, post hoc Tukey tests, the Kruskal–Wallis test and the Bonferroni correction method were used for data analysis (α = 5%). Results: In color differences (ΔE*ab) and whiteness index (ΔWID) analysis, a change of ΔE*ab ≥ 1.2 or ΔWID ≥ 0.72 was considered visually perceptible. Both groups showed clinically significant tooth whitening after 7 days and notable ΔE*ab and increases in ΔWID were observed in both groups (p < 0.05). After 14 days, both groups showed increased brightness (ΔL*) and reduced yellowness (Δb*) (p < 0.05). After 28 days, there was no discernible tooth sensitivity in the experimental group, while there was some obvious tooth sensitivity in the control group. Both groups showed a significant change in tooth color compared to the baseline but there were no significant differences between the two groups. Conclusion: LESENING whitening strips with 3% hydrogen peroxide and 1.5% potassium nitrate were esthetically effective. Moreover, the LESENING group showed lower tooth sensitivity change than the Crest group. Clinical Relevance: The use of LESENING whitening strips with 3% hydrogen peroxide and 1.5% potassium nitrate for at-home dental whitening could reduce the risk of dentin hypersensitivity without compromising whitening efficacy. Trial Registration: ISRCTN registry number: ISRCTN30027746.