Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
Brief Summary:
Mandibular fractures represent approximately 50% of the total facial fractures and are commonly (more than half) presented in more than one location. A few simple fractures can be treated using a conservative approach. More often, however, mandibular fractures require stabilization using open reduction and internal fixation.
Simple mandibular fractures can be treated using non-rigid fixation techniques that rely on the load-sharing principle, by which stabilization is accomplished with both fixation devices and bone surfaces. On the other hand, more complex fractures with continuity defects or comminuted need to be handle using rigid fixation where the device assumes all the forces (load-bearing principle). These approaches are well established, whereas the level of evidence for the treatment of bilateral double mandibular fractures (DMF) is still scarce. In fact, which surgical treatment, or combination of treatments, leads to the best outcome and the lowest rate of complications in bilateral DMFs is an open question.
The purpose of this study is to assess the complication rate in patients suffering from bilateral DMF treated either using non-rigid fixation on both fracture sides or a combination of rigid fixation on one side and non-rigid fixation on the other side.