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.

Oral health-related quality of life in orthodontic patients during initial therapy with conventional brackets or self-ligating brackets.

BACKGROUND/PURPOSE: The self-ligating brackets (SLB) have been introduced in modern orthodontic treatment in recent years for malocclusion patients. This study was conducted to compare two treatments, conventional brackets (CB) and SLB, in malocclusion to determine which treatment will provide better oral health-related quality of life (OHRQoL) outcomes. MATERIALS AND METHODS: The research involved a prospective randomized clinical trial, composed of two sets of questionnaires, Short Form-36 (SF-36T) and oral health impact profile-14 (OHIP-14T), concerning HRQoL and OHRQoL. In total, 88 malocclusion patients who were eligible and met the inclusion and exclusion criteria from the Orthodontic Department of Mackay Memorial Hospital from June 2010 to November 2011 participated in the study, and all patients had completed a minimum follow-up of 1 week and 1 month. The quantitative analysis of the questionnaires was conducted through descriptive statistics and repeated measures of analysis of variance to indicate the differences in OHRQoL between the two sets of brackets systems. RESULTS: For SF-36T, the physical component score, the mental component score and all of the eight scales yielded no statistically significant differences between the CB and SLB group. For OHIP-14T, the overall score and all of the seven scales yielded no statistically significant difference between the CB and SLB group. Results of this study showed that SLB systems were not shown to be statistically superior to CB systems in improving OHRQoL for malocclusion patients during initial orthodontic treatment. CONCLUSION: This study may provide the orthodontists with a better understanding how malocclusion patients experience the change of OHRQoL and discomfort for CB systems and SLB systems during the initial fixed orthodontic therapy.