Mandibular Reconstruction Bone Plate

Mandible Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06099431
• Other study ID #: A23030123
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 16
• Est. completion date: August 30, 2024
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Mandible Tumor
• Mandibular Neoplasms

Intervention

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

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of pain	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.	1 month
Primary	Rate of inflammation	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	1 month
Primary	Rate of Infection	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.	6 months
Secondary	Axial and coronal computed tomography	Degree of bone plate stability	6 month