Custom-made reconstruction plates for segmental lower-jaw defects

Patient-specific Reconstruction Plate for Alloplastic Bridging of Segmental Mandibular Defects. A Clinical and Radiographic Study.

This study will test custom, computer-designed jaw plates made with virtual surgical planning to repair adults with segmental lower-jaw (mandibular) defects and see how well they fit and function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sex: All
• Sponsor: Alexandria University (other)
• Locations: 1 site (Alexandria, Alexandria Governorate)
• Trial ID: NCT07320924 on ClinicalTrials.gov

What this trial studies

This is a prospective interventional study enrolling 14 patients with segmental mandibular continuity defects managed at Alexandria University. Each patient will receive a patient-specific reconstruction plate created with preoperative virtual surgical planning and computer-aided design/manufacturing. Clinical follow-up will record morbidity and range of mandibular excursions, and postoperative 3D radiographic analysis will measure the accuracy of the computer-guided reconstruction. The protocol excludes defects requiring condylar resection or patients with active local infection or who are medically unfit for surgery.

Who should consider this trial

Good fit: Adults with segmental mandibular continuity defects that do not involve the condyle—due to tumors, recurrent lesions, stage-III jaw osteonecrosis/sequestrectomy indications, osteomyelitis, trauma, or gunshot injuries—who are medically fit for surgery are ideal candidates.

Not a fit: Patients who are medically unfit for surgery, have defects involving the condyle that require total joint reconstruction, or have an active infection at the surgical site are unlikely to be appropriate or to benefit from this approach.

Why it matters

Potential benefit: If successful, patient-specific plates could improve plate fit and alignment, reduce intraoperative bending and hardware stress, and lower the risk of long-term hardware complications while improving jaw function.

How similar studies have performed: Computer-aided design/manufacturing and virtual surgical planning have previously improved accuracy in maxillofacial reconstruction, but prospective data specifically on patient-specific mandibular plates remain limited.

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.

Where this trial is running

Alexandria, Alexandria Governorate

• Faculty of Dentistry, Alexandria University — Alexandria, Alexandria Governorate, Egypt (RECRUITING)

Study contacts

• Principal investigator: yehia M El-Mahallawy, Phd — Faculty of Dentistry, Alexandria University, Alexandria, Alexandria
• Study coordinator: yehia A El-Mahallawy., PhD

Conditions: Mandibular Resection, Mandibular Reconstruction* / Methods, Mandibular Reconstruction, mandibular resection, surgery, computer-assisted, computer-aided design, computer-aided manufacturing