Bone plate design for mandible fractures: patient-specific versus conventional plates
Official title: Optimized Osteosynthesis: A Comparative Analysis of Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates (A Randomized Controlled Clinical Trial)
Run by Cairo University · NCT07904897 · Data updated 2026-11-12
This trial tests whether custom, CAD/CAM-made titanium plates help bone density recover better after fixing mandibular body fractures than standard plates.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 26 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Giza Governorate) |
| Status | Recruiting |
| Started | October 12, 2026 |
| Main results expected | November 2027 |
| Study ends | January 2028 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07904897 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with unilateral or bilateral mandibular body fractures requiring ORIF and without contraindicating health conditions.
✕Probably not a fit
Patients with comminuted fractures, pre-existing malunions, or conditions prohibiting general anesthesia may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, parallel-group study compares patient-specific titanium plates designed from preoperative CT data with conventional plates that are shaped during surgery for mandibular body fractures. Bone mineral density at the fracture site will be measured by CT-derived Hounsfield Units at baseline and six months after surgery. All procedures follow a standardized surgical protocol performed by a single surgical team under general anesthesia. The primary outcome is the recovery of bone density at the fracture site, aiming to determine if CAD/CAM customization improves osseous healing compared with traditional plating.
Why it matters
Potential benefit: If successful, patients may experience faster or more complete bone healing and stronger fixation with personalized implants.
How similar studies have gone: Prior work in orthopedics has shown promise for patient-specific implants, but evidence for mandibular fractures remains emerging and this study contributes new data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unilateral or bilateral mandibular body fracture requiring open reduction and internal fixation (ORIF), presenting either isolated or concurrently with other maxillofacial, midface, or other mandibular fractures. * Patients in good general health who are medically cleared to undergo major maxillofacial surgery under general anesthesia. Exclusion Criteria: * Presence of comminuted fractures or pre-existing malunions at the fracture site. * Patients with high-risk systemic diseases or any medical conditions that contraindicate the administration of general anesthesia.
Where it's running
-
Faculty of Dentistry- Cairo University
Cairo, Giza Governorate, Egypt Recruiting
Study contacts
- Principal investigator: Dina Y Girgis — Assistant Lecturer
- Study coordinator: Dina Y Girgis
- Email: dina.yacoub@dentistry.cu.edu.eg
- Phone: 01278061226
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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.