Clinical trial NCT06099431: Mandibular Reconstruction Bone Plate
Official title: Reliability of a 2.3mm Mandibular Reconstruction Bone Plate in Mandibular Bone Preservation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mandible Tumor
Keywords: Reconstruction
bone plate
Mandible
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Degree of pain
timeFrame: 1 month
measure: Rate of inflammation
timeFrame: 1 month
measure: Rate of Infection
timeFrame: 6 months
Secondary outcomes:
measure: Axial and coronal computed tomography
timeFrame: 6 month
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Gharbia
Study officials:
affiliation: Tanta University
name: Mohamed K Allam, Ass prof
role: PRINCIPAL_INVESTIGATOR
References: