Custom-made reconstruction plates for segmental lower-jaw defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: yehia.el-mahallawy@alexu.edu.eg
• Phone: +201007217014.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.