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NCT Number: NCT07320924

Patient-specific Reconstruction Plate for Segmental Mandibular Defects

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.

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Key information

Conditions

Mandibular Resection Mandibular Reconstruction Mandibular Reconstruction* / Methods

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

Location status: Recruiting

Location contact

Yehia A El-Mahallawy, PhD

CONTACT

[email protected]

+201007217014

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient specific reconstruction plate

Device

Patient specific reconstruction plate

Primary outcomes

  1. Postoperative complications and degree of morbidity

    Time frame: 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 outcomes

  1. Functional Range of Mandibular Excursions

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

yehia A El-Mahallawy., PhD

CONTACT

[email protected]

+201007217014. ext. 002

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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