NCT07320924

Patient-specific Reconstruction Plate for Segmental Mandibular Defects

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The study aims to assess the clinical performance and morbidity rate of computer-guided PSRP in the management of mandibular segmental defects. This prospective interventional clinical trial will be conducted on a total of 14 patients with a segmental mandibular defect, recruited from Alexandria University Teaching Hospital. All patients will be reconstructed using a PSRP alloplastic bridging plate, utilizing a preoperative virtual surgical planning and design. Patients will be evaluated clinically for the rate of morbidity and range of mandibular excursions. Furthermore, postoperative radiographic 3D analysis will evaluate the accuracy of the computer-guided procedure.

Conditions

• Mandibular Resection
• Mandibular Reconstruction* / Methods
• Mandibular Reconstruction

Interventions

Type	Name	Description
DEVICE	Patient specific reconstruction plate	Patient specific reconstruction plate

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-05-30
• Completion: 2026-08-30
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: Egypt