Comparative Evaluation of Outcomes of Single vs Double Miniplate Fixation in Symphysis and Parasymphysis Mandibular Fractures: A Randomized Controlled Trial.

The study “Comparative Evaluation of Outcomes of Single vs. Double Miniplate Fixation in Symphysis and Parasymphysis Mandibular Fractures: A Randomized Controlled Trial” has been approved by the Institutional Ethics Committee (IEC), AIIMS Patna. Led by Dr. Kumar Mayank, with a multidisciplinary team of guides and co-guides, it aims to address the lack of robust evidence comparing single and dual miniplate fixation in mandibular fractures. Traditionally, two miniplates following Champy’s principles have been used, but this approach increases surgical time and risks, including dental or mental nerve injury, infection, and wound dehiscence. Single high-profile miniplate fixation may provide comparable stability with fewer complications and lower costs.

This single-center, open randomized controlled trial will enroll 80 adult patients (18–65 years) presenting with symphysis or parasymphysis mandibular fractures eligible for open reduction and internal fixation. After informed consent, patients will be randomized into two groups: Group A (single 2.0 mm miniplate) and Group B (dual 2.0 mm miniplates). Preoperative NCCT with 3D reconstruction will assess fracture details. Follow-ups will occur at 1, 2, 4, 6, and 12 weeks.

Primary outcomes include operative time, wound infection or dehiscence, nerve injury or paresthesia, plate exposure, and hardware stability. Secondary outcomes include fracture union at 1 and 12 weeks, occlusion, mandibular deviation, mouth opening, pain scores, and patient-reported recovery. Statistical analysis using Jamovi software will consider p<0.05 significant.

By providing high-quality comparative data, this study aims to establish whether single miniplate fixation is as effective as dual plating while reducing complications and costs. The findings are expected to improve patient care, optimize surgical resources, and inform standardized treatment protocols, particularly in resource-limited settings such as Bihar. Ethical approval has been granted, and the study will be conducted as per ICMR and GCP guidelines.