Mandibular Reconstruction Bone Plate

Trial Title: Mandibular Reconstruction Bone Plate

NCT ID: NCT06099431

Condition: Mandible Tumor

Conditions: Official terms:
Mandibular Neoplasms

Conditions: Keywords:
Reconstruction
bone plate
Mandible

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Mandibular marginal resection and reconstruction
Description: 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.
Arm group label: Surgery/Device

Intervention type: Device
Intervention name: mandibular osteosynthesis a 2.3mm reconstruction bone plate
Description: a 2.3 mm reconstruction bone plate was then fit in place and fixed to both the proximal and distal segments
Arm group label: Surgery/Device

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - patients suffering from presence of mandibular central benign lesions indicated for marginal mandibular resection Exclusion Criteria: - systemic disease affect primary wound healing malignancy

Gender: All

Minimum age: 12 Years

Maximum age: 50 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Tanta University

Address:
City: Tanta
Zip: 3111
Country: Egypt

Start date: December 22, 2022

Completion date: August 30, 2024

Lead sponsor:
Agency: Tanta University
Agency class: Other

Source: Tanta University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06099431