Custom-made Titanium Plates vs Custom-made PEEK Plates for mandible fractures
Official title: Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates for Fixation of Mandibular Fractures
Run by Mansoura University · NCT07850570 · Data updated 2026-11-12
This study tests whether custom-made titanium or custom-made PEEK plates work better to fix mandibular fractures in adults 18 to 50.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Status | Recruiting |
| Started | September 24, 2026 |
| Main results expected | March 24, 2027 |
| Study ends | September 24, 2028 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07850570 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–50 with recent (≤10 days) displaced unilateral or bilateral mandibular fractures requiring open reduction and internal fixation, and who are ASA I.
✕Probably not a fit
Patients with comorbidities beyond ASA I, old or infected fractures, or non-displaced fractures may not benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares two custom fixation materials—titanium and PEEK—for open reduction and internal fixation of mandibular fractures. Eligible participants are adults aged 18–50 with recent, displaced unilateral or bilateral fractures requiring internal fixation and with ASA I health status. The trial aims to determine how plate material influences stability, healing, and function, using standard surgical procedures and follow-up assessments. It is conducted at Mansoura University in Egypt, led by the university’s dental faculty. Outcomes will inform whether material choice affects clinical outcomes, imaging compatibility, and patient recovery after mandibular fracture repair.
Why it matters
Potential benefit: If successful, the study could identify a plate material that improves healing, reduces complications, and preserves function after mandible fracture repair.
How similar studies have gone: Previous research supports titanium for its strength, while newer materials like PEEK offer imaging advantages; direct comparisons are limited, making this study relatively novel in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients age ranging from 18 to 50 years. * Unilateral and/or bilateral simple or compound fractures of the mandibular symphysis, parasymphysis or body regions that are displaced and require open reduction with internal fixation. * The fractures must be recent, having occurred no longer than 10 days prior to the surgical treatment. * Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I. Exclusion Criteria: * Patients suffer from pathological fractures. * Comminuted and infected fractures. * Fracture of the atrophic edentulous ridge * Old mandibular fractures (more than 10 days). * Patients with ASA classes II, III, IV, and V.
Where it's running
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Mansoura University, Faculty of Dentistry
Al Mansurah, Dakahlia Governorate, Egypt Recruiting
Study contacts
- Principal investigator: Aya ali Elsies, assistant lecturer — Faculty of Dentistry, Mansoura University
- Study coordinator: aya ali Elsies, assistant lecturer
- Email: ayaalialsies@mans.edu.eg
- Phone: 0201091797600
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.