Patient-specific Reconstruction Plate for Segmental Mandibular Defects

NCT07320924 | Recruiting

• 1 other identifier: 20-12-25/PSRP
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Resection; Mandibular Reconstruction* / Methods; Mandibular Reconstruction

Keywords

mandibular resection; surgery; computer-assisted; computer-aided design; computer-aided manufacturing; software

Outcome Measures

Primary Outcomes (1)

• Postoperative complications and degree of morbidity

  All patients will be assessed immediately post-operative, at 1 and 3 months. Any complication that arises during the clinical follow-up period will be monitored and reported. Complications include prolonged hospital stay, prolonged drug administration, signs of screw or PSRP loosening, PSRP fracture, wound dehiscence or tissue necrosis, Intra/extraoral PSRP exposure, and fistulae.

  3 months

Secondary Outcomes (1)

• Functional Range of Mandibular Excursions

  3 months

Study Arms (1)

Patient specific reconstruction plate

EXPERIMENTAL

patient with mandibular ablation defect managed with patient specific reconstruction plate

Device: Patient specific reconstruction plate

Interventions

Patient specific reconstruction plate DEVICE

Patient specific reconstruction plate

Patient specific reconstruction plate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a segmental mandibular continuity defect, not involving the condyle.
• Patients suffering from benign, locally invasive or malignant lesions that involving the lower border of the mandible.
• Patients with recurrent lesions after resection.
• Patients dealing with osteomyelitis or jaw osteonecrosis that is indicated for sequestrectomy.
• Stage-III jaw osteonecrosis.
• Patients with traumatic defects.
• Patients with post-gunshot mandibular defects.

You may not qualify if:

• Medically compromised patients contradict the operation.
• Patients with segmental mandibular defects that require condylar process resection
• Patients with lateral segmental mandibular defects involving the condyle that require reconstruction using an alloplastic total joint.
• Patients with an active infection at the site of resection.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

RECRUITING

Study Officials

• yehia M El-Mahallawy, Phd

  Faculty of Dentistry, Alexandria University, Alexandria, Alexandria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yehia A El-Mahallawy., PhD

CONTACT

+201007217014.; yehia.el-mahallawy@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)