Tai-Ting Lai1, Jeng-Yuan Chiou2, Tai-Cheng Lai3, Ted Chen4, Huey-Yuan Wang5, Chung-Hsing Li6, Min-Huey Chen7. 1. Division of Orthodontics, Dental Department, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Medicine, Nursing and Management College, Taipei, Taiwan; Orthodontics and Detofacial Orthopedics Division, Dental Department, Tri-Service General Hospital, Taipei, Taiwan; School of Dentistry, College of Oral Medicine, Taipei Medical University, Taiwan. 2. School of Health Policy and Management, Chung Shan Medical University, Taiwan. 3. Department of Public Health, Kaohsiung Medical University, Kaohsiung, Taiwan. 4. School of Public Health & Tropical Medicine, Tulane University, New Orleans, USA. 5. Division of Orthodontics, Dental Department, Mackay Memorial Hospital, Taipei, Taiwan. 6. Orthodontics and Detofacial Orthopedics Division, Dental Department, Tri-Service General Hospital, Taipei, Taiwan. 7. Graduate Institute of Clinical Dentistry, School of Dentistry, National Taiwan University, Taiwan; Dental Department, National Taiwan University Hospital, Taiwan. Electronic address: minhueychen@ntu.edu.tw.
Abstract
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.
RCT Entities:
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 malocclusionpatients 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.
Authors: Laura Antonio-Zancajo; Javier Montero; Daniele Garcovich; Mario Alvarado-Lorenzo; Alberto Albaladejo; Alfonso Alvarado-Lorenzo Journal: Biology (Basel) Date: 2021-04-28