Patient-specific Reconstruction Plate for Segmental Mandibular Defects

N/ARecruitingNCT07320924

Alexandria University14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

Functional Range of Mandibular Excursions

The range of mandibular excursions will be objectively recorded using a caliper measurement during the clinical follow-up periods. The following excursions will be recorded: Intra-Incisal Mouth Opening (I-IMO) Dental Midline Deflection on Opening (DMD-O) Chin Midline Deflection on Opening (CMD-O)