MedTrace Logo

Minimally Invasive Dental Occlusion Ties

NCT04985461 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2021-08-02

No results posted yet for this study

Summary

Patients sustaining fractures of the upper (maxilla) and/or lower (mandible) jaw may be candidates for the minimally invasive technology evaluated in this study. Patients will be offered standard care including steel jaw wires or the polymer-based "zip tie"-like devices to be studied. Written consent with a full explanation of traditional "jaw wiring" techniques versus this experimental approach will be obtained from the patient. As mandible and maxilla fractures are typically treated under general anesthesia in the operating room, the devices will be applied to the patient's dentition while under general anesthetic. An exception to this will be minimally displaced or easily reduced fractures that can be treated by applying these devices in clinic under topical or local anesthetic. (Of note, wire-based techniques have been used for decades in a clinic-based application for such minimally or easily-reduced fractures.) The devices will allow stabilizing forces to the dental occlusion, achieving a similar function to temporary steel wire techniques ("arch bars"). This will allow the surgeon/principal investigator to treat the fractures with standard techniques such as applying titanium plates applied to the bone with titanium screws (known as "open reduction with internal fixation") or with sustained immobilization for 1-6 weeks (known as "closed reduction"). Note the devices are approved for 3 weeks duration. If treatment requires more than 3 weeks of immobilization, the devices will be removed and new devices re-applied. The experimental devices will be used solely as a replacement for wire-based techniques to achieve an immobile, stable jaw. If for any reason the required forces needed for jaw fracture stabilization are deemed inadequate with the experimental devices, standard steel wire techniques will be employed.

Conditions

  • Jaw Fractures
  • Jaw; Fracture, Upper Jaw
  • Mandibular Fractures
  • Maxilla Fracture
  • Jaw Fixation

Interventions

DEVICE

dental occlusion ties maxillo-mandibular fixation

This research study is being done to determine if dental occlusion ties can adequately align and stabilize jaw fractures. The chief goal of jaw fracture repair is to ensure that the teeth align normally. Traditionally, alignment has been accomplished by using steel wires and bars ("having the jaw wired"). Dental occlusion ties are newer devices similar to cable ties or "zip ties" that are wrapped around and/or between some of the teeth and secured. This procedure is intended to hold the teeth in similar alignment as wires, yet with less application time and less damage to the gums.

Sponsors & Collaborators

  • Altru Health System

    lead OTHER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2020-03-12
Completion
2020-03-12
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04985461 on ClinicalTrials.gov