Minimally Invasive Dental Occlusion Ties Clinical Trial

Background: Mandible fractures are the second most common facial fractures behind nasal fractures. Like other fractures in the body, immobilization of the fractured segments is required for healing. For various fractures, immobilization can be achieved through casts, surgically-implanted hardware (plates, rods, screws), and other methods. Jaw fractures (mandible and maxilla) benefit from their unique connection to dentition. As the teeth are rigidly connected to the mandible and maxilla, jaw fractures can be immobilized by immobilizing the teeth in anatomic orientation. Placing the teeth in anatomic orientation (known as "dental occlusion") ensures that the cusps and the facets of the teeth fit appropriately as the fracture heals. The process of achieving this positioning is referred to as maxillo-mandibular fixation. The current leading technology to achieve maxillo-mandibular fixation (MMF) is "jaw wiring," commonly referred to as "arch bars" by facial trauma surgeons. Arch bars have been a standard of care for decades and almost invariably require application under general anesthetic for patient tolerance. Alternative variations of jaw wiring include Ivy loops, Ernst ligatures, and screw fixation approaches - all of which have achieved minimal adoption because of significant drawbacks. Wire-based MMF techniques commonly use 24 gauge stainless steel wires. The alternative wiring techniques (i.e., Ivy loops, Ernst ligatures) offer speed of application, but still require considerable manipulation by the surgeon in an operating room to apply them to the patient. The screw fixation techniques pose risks to tooth roots and to the gingiva (gums) and have also shown very limited clinician adoption.

All of these techniques, including the more widely adopted arch bars, induce considerable trauma to the gums and mucosa of the patient, causing considerable pain. Also, as these techniques are applied in the operating room under general anesthesia, the techniques incur considerable cost due to the time-consuming nature of these techniques. Further, the metal wires used in these techniques can be rigid and pointed, placing the surgical team at risk for sharps injuries.

Thus, there is a need for improved devices, systems and methods for achieving maxillo-mandibular fixation in a manner that can minimize patient discomfort, avoid the intensive labor and financial demands of such approaches, and provide a safer application for the surgical team.

This observational clinical trial aims to assess the 1) efficacy of treating mandible/maxilla fractures, 2) efficiency of application, 3) tissue trauma characteristics of a novel new cable tie-like device system used to replace wire-based techniques of maxillo-mandibular fixation, 4) the potential for these devices to be successfully applied in a clinic setting, 5) the post-treatment course for patients treated with prolonged stabilization (typically 1-6 weeks of maxillo-mandibular fixation), 6) patient's experience while wearing dental occlusion ties, and 7) the surgeon's experience with and impression of these new devices.

Study Design: