Perceived pain for orthodontic patients with conventional brackets or self-ligating brackets over 1 month period: A single-center, randomized controlled clinical trial

Background/Purpose: The objective of this 2-arm parallel trial was to test the superiority of self-ligating brackets (SLB) over conventional brackets (CB) in terms of perceived pain for orthodontic patients. Methods: Patients about to undergo treatment were included to fixed appliance placed with CB or SLB. Eligibility criteria included malocclusion patients whose age between 12 to 40 years and suitable for orthodontic fixed appliance treatment. The main outcome was pain intensity measured by visual analog scale (VAS) with all patients followed at 4 h, 24 h, 3 days, 1 week and 1 month. Randomization was accomplished with a computer-generated list of random numbers. Blinding was applicable for outcome assessment only. Data were analyzed using multi-level nonlinear mixed effect model, Friedman's test and Wilcoxon signed rank test with the Bonferroni correction for multiple tests. Results: Eight-eight patients were randomized in a 1:1 ratio to either SLB or CB. All patients completed the study, and none were lost to follow-up. There were no drop-outs after randomization. Baseline characteristics were similar between groups. The is no statistical significant difference in pain intensity between CB and SLB at 4 h, 24 h, 3 days, 1 week and 1 month. Data were analyzed on an intention-to-treat basis. No serious harm was observed. Conclusion: The results of this study indicated no evidence that the pain intensity differs between CB and SLB at 4 h, 24 h, 3 days, 1 week and 1 month. Copyright (C) 2019, Formosan Medical Association. Published by Elsevier Taiwan LLC.