Comparative Trial of Custom-Made Titanium Plates Versus 3D Lambda Plates for Mandibular Subcondyl… (NCT07231055) | Clinical Trial Compass
CompletedNot Applicable
Comparative Trial of Custom-Made Titanium Plates Versus 3D Lambda Plates for Mandibular Subcondylar Fractures
Egypt24 participantsStarted 2024-12-28
Plain-language summary
This randomized clinical trial compares virtually designed custom-made titanium plates with conventional three-dimensional (3D) lambda plates for the fixation of mandibular subcondylar fractures. A total of 24 fracture sites will be treated using a retromandibular trans-masseteric approach and evaluated through virtual surgical planning, radiographic analysis, and functional outcomes. The study aims to determine whether customized plates provide superior anatomical accuracy, stability, and recovery compared with standard 3D plates.
Who can participate
Age range
21 Years – 55 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:
* Adult Patients with mandibular subcondylar fracture indicated for open reduction and internal fixation.
Exclusion Criteria:
* Patients with systemic diseases that affect tissue healing.
* Mandibular condylar head or neck fractures. (Condylar neck is the where the caudal portion of the joint capsule attaches. It is the thin constricted area immediately below the condylar head.)
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
Operative time
Timeframe: Intraoperative (recorded during the surgical procedure)