Mandibular Reconstruction Bone Plate

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Mandible Tumor
• Intervention / Treatment: Procedure: Mandibular marginal resection and reconstruction; Device: mandibular osteosynthesis a 2.3mm reconstruction bone plate

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 3111
      • Tanta university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Surgery/Device; Mandibular marginal resection and reconstruction using a mandibular osteosynthesis a 2.3mm reconstruction bone plate

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial and coronal computed tomography	Degree of bone plate stability	6 month

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Mohamed K Allam, Ass prof, Tanta university

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Estimated): December 10, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Reconstruction; Mandible; bone plate
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Jaw Diseases; Bone Neoplasms; Mandibular Diseases; Skull Neoplasms; Jaw Neoplasms; Mandibular Neoplasms
• Other Study ID Numbers: A23030123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No