Mandibular Reconstruction, Mandibular Reconstruction* / Methods, Mandibular Resection
Conditions
Keywords
mandibular resection, surgery, computer-assisted, computer-aided design, computer-aided manufacturing, software
Brief 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.
Interventions
DEVICEPatient specific reconstruction plate
Patient specific reconstruction plate
Sponsors
Alexandria University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications and degree of morbidity | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Range of Mandibular Excursions | 3 months | 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) |
Countries
Egypt
Contacts
Primary Contactyehia A El-Mahallawy., PhD
Outcome results
None listed