Mandibular changes during initial alignment with SmartClip self-ligating and conventional brackets: A single-center prospective randomized controlled clinical trial

Objective: To test the null hypothesis that SmartClip self-ligating brackets are more effective than conventional brackets for initial mandibular alignment and identify influential factors. Methods: Fifty patients were randomly allocated to two equal treatment groups by using an online randomization program: self-ligating group (SmartClip brackets) and conventional group (Gemini brackets). The archwire sequence was standardized. Changes in anterior irregularity index, intercanine width, and intermolar width were assessed on plaster models at 8th and 16th weeks. Changes in incisor position and inclination were assessed on lateral cephalometric radiographs at 16 weeks. Intragroup and intergroup comparisons were performed with paired t-test and Student's t-test, respectively. Multiple linear regression was performed to identify variables affecting improvement in anterior ambiguity. Results: Data of 46 patients were analyzed; those missing an appointment (n = 2) or showing bracket breakage (n = 2) were excluded. Incisor inclination (p < 0.05), intercanine width (p < 0.05), and intermolar width (p > 0.05) increased at 8 and 16 weeks in both the groups; no significant intergroup differences were noted (p > 0.05). Initial anterior irregularity index and intercanine width change were significantly associated with improvement in anterior irregularity (p < 0.001). Conclusions: The null hypothesis was rejected. Bracket type has little effect on improvement in anterior ambiguity during initial mandibular alignment.