NCT06099431

Mandibular Reconstruction Bone Plate

Reliability of a 2.3mm Mandibular Reconstruction Bone Plate in Mandibular Bone Preservation

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the reliability of using mandibular osteosynthesis a 2.3mm reconstruction bone plate in the maintenance of the space, contour, and mandibular bone preservation during marginal mandibular resection.

Detailed description

This prospective study included 16 patients (n=16) suffering from presence of mandibular central benign lesions indicated for marginal mandibular resection. Patient history included personal data (name, age, sex, and occupation), date of lesion discovery, mode of growth (rapid or slow), and symptoms (e.g. pain and/or ipsilateral paresthesia of the lower lip). Clinical examination included the site and extent of mandibular bony expansion and covering soft tissues (normal, ulcerated from indentation of opposing teeth, or scarred due to previous incisional biopsy). Radiographical examination involved orthopantomography (OPG) and axial and coronal computed tomography (CT) scans to assess the lesion extensions. All patients are operated under general anesthesia which was induced by intravenous access. Intubation is routinely performed in nasoendotracheal fashion. Intraoral buccal and lingual incisions 2-3 mm away from the free gingival margins are carried out around the teeth to be included in the resection. The plastic template is adapted to the buccal cortex of the mandible to aid in the final adaptation of a 2.3 mm reconstruction bone plate (Antonhib, Germany). The osteotomy lines are marked using a long shank surgical tapered fissure bur. a 2.3 mm reconstruction bone plate is then fit in place and fixed to both the proximal and distal segments then removed. The osteotomies completed and the resected segment is removed, and the reconstruction plate is then replaced by the aid of screw holes in both the proximal and distal segments. The intraoral wound is carefully closed in double layers using a combination of interrupted and horizontal mattress resorbable 3/0 sutures. post operative follow up clinically regarding soft tissue healing, pain, infection, and plate exposure or plate fracture. Radiographically, Panoramic radiographs are taken immediately and axial and coronal computed tomography at six months post-operatively.

Conditions

• Mandible Tumor

Interventions

Type	Name	Description
PROCEDURE	Mandibular marginal resection and reconstruction	Intraoral buccal and lingual incisions 2-3 mm away from the free gingival margins were carried out around the teeth to be included in the resection. The osteotomy lines were marked using a long shank surgical tapered fissure bur. The osteotomies completed and the resected segment was removed.
DEVICE	mandibular osteosynthesis a 2.3mm reconstruction bone plate	a 2.3 mm reconstruction bone plate was then fit in place and fixed to both the proximal and distal segments

Timeline

• Start date: 2022-12-22
• Primary completion: 2025-12-10
• Completion: 2025-12-30
• First posted: 2023-10-25
• Last updated: 2025-04-10

Locations

1 site across 1 country: Egypt