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Recruiting NCT07320924

Patient-specific Reconstruction Plate for Segmental Mandibular Defects

No phase Interventional Mandibular Resection Mandibular Reconstruction* / Methods Mandibular Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient specific reconstruction plate.
Who it may be relevant to
Registry conditions: Mandibular Resection, Mandibular Reconstruction* / Methods, Mandibular Reconstruction. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

Interventions

  • Device Patient specific reconstruction plate
    Patient specific reconstruction plate

Primary outcome measures

  • Postoperative complications and degree of morbidity [Time frame: 3 months]
Secondary outcome measures (1)
  • Functional Range of Mandibular Excursions [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Alexandria University — Alexandria

Identifiers

NCT: NCT07320924 · 20-12-25/PSRP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗