Efficacy and safety of low-concentration whitestrips for extrinsic tooth discoloration: a randomized controlled trial

Objectives: This study aimed to evaluate the effectiveness of Low-concentration Whitestrips with 3% hydrogen peroxide (HP) on extrinsic discoloration of incisors, and to evaluate the safety of whitening process. Methods: Enrolled adults with extrinsic discolored incisors (Vita shade guide value >1M1.5) were randomized into treatment and control groups. Treatment group used Low-concentration Whitestrips, control group used placebo. Tooth color was assessed at baseline and follow-up visits at Day 1, Day 3 and Day 14. Tooth color was assessed by digital shade meter (primary outcomes), and VITA 3D-Master shade guide (secondary outcomes), respectively. Adverse events (AEs) and serious adverse events (SAEs) including oral and systemic symptoms based on clinical examination and participants' description were also recorded. Results: > 0.05). No SAEs were reported. Conclusions: From both objective and subjective perspectives, Low-concentration Whitestrips were found to be effective in extrinsic discoloration tooth bleaching and were well-tolerated by participants. Clinical Trial Registration: Chinese Clinical Trial Registry: https://www.chictr.org.cn/ (ChiCTR2300073971) and National Health Information Platform: http://114.255.48.20/login (MR-51-23-033324).