Patient-specific Reconstruction Plate for Segmental Mandibular Defects

ConditionsMandibular Resection Mandibular Reconstruction* / Methods Mandibular Reconstruction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorAlexandria University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Patient specific reconstruction plate
Device
Patient specific reconstruction plate

Treatment groups

14 Participants

are divided into 1 treatment group

Group A: Patient specific reconstruction plateExperimental treatment 1 intervention

Trial 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)

Time frame

3 months

Sponsors and contacts

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Alexandria University

Lead sponsor

Source ClinicalTrials.gov

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