Prospective Randomized Clinical Trial Comparing Bite Force in 2-mm Locking Plates Versus 2-mm Standard Plates in Treatment of Mandibular Fractures

Purpose: To compare the efficacy of the 2-mm locking miniplates to 2-mm standard miniplates in the osteosynthesis of mandibular fractures on the basis of clinical parameters and bite force recording. Patients and Methods: A prospective randomized clinical trial was conducted at the Faculty of Dental Science, CSMMU (formerly King Georges Medical College), Lucknow, India, from January 1, 2007, to January 31, 2008, to treat consecutive mandible fractures. The patients were randomly divided into 2 groups. The patients underwent osteosynthesis-group 1 with Synthes 2-mm locking titanium miniplates and group 2 with Synthes 2-mm nonlocking titanium miniplates. The cause of trauma, the number of days from injury to surgery, average age, gender, and site distribution were all reviewed. The assessment of the patients was done at 1, 3, and 6 weeks and 3 months using the clinical parameters and bite force recording. Results: A total of 20 patients with 32 fractures met the inclusion criteria. In our study, a statistically significant difference was not found in the clinical parameters such as pain, swelling, infection, paresthesia, hardware failure, and mobility between the fracture segments. A statistically significant difference was found between the change in bite force from the previous follow-up visit in groups 1 and 2. From 1 week to 3 months, the change in the incisor bite force was significantly greater for group 1 than for group 2. At 6 weeks and 3 months, the change in right molar bite force from the previous follow-up visit was significantly greater for group 1 than for group 2. At the 1-, 3-, 6-week and 3-month follow-up visits, the change in left molar bite force from the previous follow-up visit was significantly greater for group 1 than for group 2. Conclusion: These findings show that the use of locking miniplates plate in mandibular fracture was efficacious enough to bear the masticatory loads during osteosynthesis of the fracture. The locking miniplates provide the advantage of a greater bite force, with clinical results almost similar to those seen with nonlocking miniplate osteosynthesis. (C) 2011 American Association of Oral and Maxillofacial Surgeons J Oral Maxillofac Surg 69: 1995-2000, 2011