RecruitingNot ApplicableNCT07320924

Patient-specific Reconstruction Plate for Segmental Mandibular Defects

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


Sponsor

Alexandria University

Enrollment

14 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Inclusion Criteria7

  • 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 Criteria4

  • 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.

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Interventions

DEVICEPatient specific reconstruction plate

Patient specific reconstruction plate


Locations(1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, Egypt

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NCT07320924


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