Mandibular Reconstruction Bone Plate
- Conditions
- Mandible Tumor
- Interventions
- Procedure: Mandibular marginal resection and reconstructionDevice: mandibular osteosynthesis a 2.3mm reconstruction bone plate
- Registration Number
- NCT06099431
- Lead Sponsor
- Tanta University
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 16
- patients suffering from presence of mandibular central benign lesions indicated for marginal mandibular resection
- systemic disease affect primary wound healing malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Surgery/Device Mandibular marginal resection and reconstruction Mandibular marginal resection and reconstruction using a mandibular osteosynthesis a 2.3mm reconstruction bone plate Surgery/Device mandibular osteosynthesis a 2.3mm reconstruction bone plate Mandibular marginal resection and reconstruction using a mandibular osteosynthesis a 2.3mm reconstruction bone plate
- Primary Outcome Measures
Name Time Method Degree of pain 1 month The degree of pain is determined during the follow up periods according the scale of Kerkmanov and Nordenram , Mild: require one tablet of analgesics three times/ day, Moderate: require two tablets of analgesics three times/ day, Severe: require injective analgesics.
Rate of inflammation 1 month The wounds were inspected accurately post-operatively for detecting the proper healing using inflammation score scale, 0 no inflammation,1-3 mild inflammation, 4-7,moderate inflammation, 8-10 sever inflammation
Rate of Infection 6 months using Infection score scale , mild infection which responds to antibiotics, only without the need for incision and drainage, moderate infection which needs for incision and drainage and severe infection which needs for incision and drainage in addition to hardware removal.
- Secondary Outcome Measures
Name Time Method Axial and coronal computed tomography 6 month Degree of bone plate stability
Trial Locations
- Locations (1)
Tanta University
🇪🇬Tanta, Gharbia, Egypt