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Efficacy and safety of low-concentration whitestrips for extrinsic tooth discoloration: a randomized controlled trial
Yuwei Wang1, Di Fu1, Lin Yao1
1State Key Laboratory of Oral Diseases & National Center for Stomatology & National Clinical Research Center for Oral Diseases & West China Hospital of Stomatology, Sichuan University, Chengdu, China.
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:
70 adults participated. The primary and secondary outcomes objectively and subjectively demonstrated that the treatment group exhibited better whitening effects than the control. Additionally, the treatment group was observed to attain better effects with prolonged use, with W* values based on digital shade meter increasing from 72.86 to 78.73, and the VITA 3D-Master shade guide color values decreasing from 14.91 to 11.23 (P < 0.05). Five AEs occurred with no significant difference between groups (P > 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).
