3D Custom Plate vs. Standard Titanium Plates for Mandibular Sub-condylar Fractures Fixation (NCT06978530) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
3D Custom Plate vs. Standard Titanium Plates for Mandibular Sub-condylar Fractures Fixation
30 participantsStarted 2026-04-10
Plain-language summary
This randomized clinical trial aims to conduct a comprehensive clinical and radiographic evaluation by comparing the efficacy of standard titanium fixation plates with three dimensional custom plate in the management of sub-condylar fractures. By assessing the clinical outcomes, accuracy of reduction of the fracture segments, and bite force promoted by both fixation modalities.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Displaced sub condylar fractures, requiring open reduction and rigid internal fixation
* Age ranges from 18 to 60 years
* Fracture duration less than 2 weeks
* Patients with adequate follow up duration for outcome assessment
Exclusion Criteria:
* Comminuted sub condylar fractures
* Patients with severe systemic diseases that may affect fracture healing
* Presence of any pathology at the fracture site
* Patients with previous history of mandibular surgery
* Medically compromised patients who are not fit to undergo surgery under general anesthesia
* Patients with in complete medical records or missing follow up data
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mandibular deviation on opening
Timeframe: 1 month, 3 months, and 6 months postoperatively.
2
Maximum mouth opening
Timeframe: 1 month, 3 months, and 6 months postoperatively.