Patient-specific Reconstruction Plate for Segmental Mandibular Defects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis

NCT06770868

Mandibular Resection

COMPLETED PHASE2

3D Interlocking Miniplates in Fixation of Mandibular Fractures in the Mental Foramen Region: A Split-mouth Study

NCT06939010

Mandibular Fractures Miniplate

COMPLETED PHASE4

Mandibular Reconstruction With Axially Vascularised Bone Substitutes

NCT04001842

Mandibular Deficiency

RECRUITING NA

Custom-Made 3D PEEK for Fixation of Mandibular Angle Fractures.

NCT07156812

Mandibular Angle Fracture Three Dimensional Polyetheretherketone

COMPLETED PHASE4

Virtual Lesion Segmentation and Mandibular Ameloblastoma Radiographic Safety Margin

NCT07306962

Ameloblastoma

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Mandibular Resection Mandibular Reconstruction* / Methods Mandibular Reconstruction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient specific reconstruction plate

patient with mandibular ablation defect managed with patient specific reconstruction plate

Group Type EXPERIMENTAL

Patient specific reconstruction plate

Intervention Type DEVICE

Patient specific reconstruction plate

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Patient specific reconstruction plate

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No