NCT07320924 Patient-specific Reconstruction Plate for Segmental Mandibular Defects
| NCT ID | NCT07320924 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alexandria University |
| Condition | Mandibular Resection |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 14 participants in total. It began in 2025-01-01 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The mandible's horseshoe-shaped anatomy makes the reconstruction of segmental defects a challenging procedure. Conventional reconstruction typically relies on alloplastic plates to bridge bony stumps; however, these require extensive intraoperative bending, often resulting in imperfect adaptation, press-to-contact fixation, and residual stresses that increase the risk of hardware fatigue and fracture. Recent advances in computer-aided design and manufacturing (CAD/CAM) and virtual surgical planning (VSP) have improved precision in maxillofacial reconstruction. Patient-Specific Reconstruction Plates (PSRP), developed from virtual planning and patient-specific anatomical data, offer a bespoke contour adaptation, predictable screw positioning, and elimination of press-fit deformation. This customization improves alignment, mechanical stability, and long-term outcomes.
Eligibility Criteria
Inclusion Criteria: 1. Patients with a segmental mandibular continuity defect, not involving the condyle. 2. Patients suffering from benign, locally invasive or malignant lesions that involving the lower border of the mandible. 3. Patients with recurrent lesions after resection. 4. Patients dealing with osteomyelitis or jaw osteonecrosis that is indicated for sequestrectomy. • Stage-III jaw osteonecrosis. 5. Patients with traumatic defects. 6. Patients with post-gunshot mandibular defects. Exclusion Criteria: 1. Medically compromised patients contradict the operation. 2. Patients with segmental mandibular defects that require condylar process resection 3. Patients with lateral segmental mandibular defects involving the condyle that require reconstruction using an alloplastic total joint. 4. Patients with an active infection at the site of resection.
Contact & Investigator
yehia M El-Mahallawy, Phd
PRINCIPAL INVESTIGATOR
Faculty of Dentistry, Alexandria University, Alexandria, Alexandria
Frequently Asked Questions
Who can join the NCT07320924 clinical trial?
This trial is open to participants of all sexes, studying Mandibular Resection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07320924 currently recruiting?
Yes, NCT07320924 is actively recruiting participants. Contact the research team at yehia.el-mahallawy@alexu.edu.eg for enrollment information.
Where is the NCT07320924 trial being conducted?
This trial is being conducted at Alexandria, Egypt.
Who is sponsoring the NCT07320924 clinical trial?
NCT07320924 is sponsored by Alexandria University. The principal investigator is yehia M El-Mahallawy, Phd at Faculty of Dentistry, Alexandria University, Alexandria, Alexandria. The trial plans to enroll 14 participants.