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NCT04985461 · ClinicalTrials.gov registry record
Minimally Invasive Dental Occlusion Ties
A clinical trial of Mandibular Fractures and Maxilla Fracture, sponsored by Altru Health System.
- Completed
- Registry status
- 10
- Enrollment target
- 1
- Study location
NCT04985461 is a study of Mandibular Fractures and Maxilla Fracture that has completed, run by Altru Health System. The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04985461, a study of Mandibular Fractures and Maxilla Fracture, has completed, sponsored by Altru Health System.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DEVICE dental occlusion ties maxillo-mandibular fixation
Study Locations (1)
North Dakota
- Altru Health System - Grand Forks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-06-30 |
| Est. Completion | 2020-03-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04985461
The ClinicalTrials.gov registry entry for NCT04985461 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Altru Health System, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Mandibular Fractures appearing as the primary indexed condition, and to 1 intervention - of which dental occlusion ties maxillo-mandibular fixation is the first listed.
NCT04985461 reports 1 study location spanning 1 distinct geographic area - top geographies include North Dakota.
Frequently Asked Questions
What is clinical trial NCT04985461 about?
NCT04985461 is a clinical study titled "Minimally Invasive Dental Occlusion Ties". 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 consen...
What is the current status of trial NCT04985461?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2017-06-30. Estimated completion is 2020-03-12.
What conditions does trial NCT04985461 study?
This clinical trial studies the following conditions: Mandibular Fractures, Maxilla Fracture, Jaw Fractures, Jaw; Fracture, Upper Jaw, Jaw Fixation.
What interventions are being tested in trial NCT04985461?
The interventions under investigation include: dental occlusion ties maxillo-mandibular fixation (DEVICE).
Who is sponsoring clinical trial NCT04985461?
This trial is sponsored by Altru Health System, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04985461 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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