Clinical effect of 3.0% hydrogen peroxide containing bleaching patch with primer in a double-blind randomized controlled trial

Abstract

Background: To clinically evaluate the efficacy and safety of a primer that contains taurine and self-bleaching patches containing 3.0% hydrogen peroxide.Methods: Overall, 55 participants were selected in this double-blinded randomized clinical trial between March and May 2019. Bleaching patches containing 3.0% hydrogen peroxide were attached using the primer on the labial surface of the upper six anterior teeth for 30 min once daily. △E* values of color changes were measured using Shade Eye NCC for determining the efficacy of bleaching on days 3, 5, 7, and 10 before and after attachment. The safety was assessed using gingival index and visual analog scale for tooth sensitivity and gingival irritation, respectively.Results: △E* values were visibly detected from day 7 after the attachment of patches, and the bleaching effect was identifiable. No statistically significant difference was observed in the gingival index (p = 0.069), tooth sensitivity (p = 0.983), and gingival irritation (p = 0.518).Conclusions: When the self-bleaching patches using 3.0% hydrogen peroxide with the primers were attached for 30 min once daily, visible bleaching effect was observed from day 7 of attachment, and it was verified to be safe for use without any significant adverse effect.Clinical Relevance: This study was conducted after securing safety for clinical trials.Trial registration: ISRCTN63650330