Minimally Invasive Dental Occlusion Ties

NCT04985461 | Completed FDA Device

• 1 other identifier: ENT-002
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

jaw fractures; mandibular fractures; maxilla fracture; jaw fixation; maxillo-mandibular fixation

Outcome Measures

Primary Outcomes (2)

• fracture reduction

  Patients will be assessed after treatment with a CT scan to assess if the fracture has been reduced or not (This is a binary variable as stated by the radiologist reading the study).

  typically within the first 24 hours after surgery

• fracture healing

  Patients will be evaluated in clinic for post-operative healing. Those discharged from clinic without a need for hardware removal or revision surgery will be considered healed. (This is a binary variable - healed vs not-healed.)

  6 weeks post-operatively

Secondary Outcomes (2)

• efficiency of application - number of ties applied

  intra-operative or immediately post-operative

• efficiency of application - time required for surgery

  intra-operative or immediately post-operative

Interventions

dental occlusion ties maxillo-mandibular fixation DEVICE

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.

Also known as: maxillo-mandibular fixation

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients included in this study are those with mandible and/or maxilla fractures treated at a level II trauma hospital in a rural U.S. setting.

You may qualify if:

• Patients sustaining any form of mandible or maxilla fracture

You may not qualify if:

• Patients with inadequate dentition (ie an edentulous patient)
• Patients under 12 years of age
• patients with comminuted mandible and/or maxilla fractures requiring advanced trauma techniques
• patients unable to consent for him/herself due to intoxication, mental illness, or unconscious state, and
• patients who are pregnant

Sponsors & Collaborators

• Altru Health System: lead

Study Sites (1)

Altru Health System

Grand Forks, North Dakota, 58201, United States

Location

MeSH Terms

Conditions

Jaw Fractures; Maxillary Fractures; Mandibular Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Otolaryngology, Principal Investigator

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: August 2, 2021
• Study Start: June 30, 2017
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)