search
Back to results

Mandibular Reconstruction Bone Plate

Primary Purpose

Mandible Tumor

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mandibular marginal resection and reconstruction
mandibular osteosynthesis a 2.3mm reconstruction bone plate
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandible Tumor focused on measuring Reconstruction, bone plate, Mandible

Eligibility Criteria

12 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tanta University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Surgery/Device

Arm Description

Mandibular marginal resection and reconstruction using a mandibular osteosynthesis a 2.3mm reconstruction bone plate

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

Axial and coronal computed tomography
Degree of bone plate stability

Full Information

First Posted
October 9, 2023
Last Updated
October 19, 2023
Sponsor
Tanta University
search

1. Study Identification

Unique Protocol Identification Number
NCT06099431
Brief Title
Mandibular Reconstruction Bone Plate
Official Title
Reliability of a 2.3mm Mandibular Reconstruction Bone Plate in Mandibular Bone Preservation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
March 10, 2023 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandible Tumor
Keywords
Reconstruction, bone plate, Mandible

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery/Device
Arm Type
Other
Arm Description
Mandibular marginal resection and reconstruction using a mandibular osteosynthesis a 2.3mm reconstruction bone plate
Intervention Type
Procedure
Intervention Name(s)
Mandibular marginal resection and reconstruction
Intervention 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.
Intervention Type
Device
Intervention Name(s)
mandibular osteosynthesis a 2.3mm reconstruction bone plate
Intervention Description
a 2.3 mm reconstruction bone plate was then fit in place and fixed to both the proximal and distal segments
Primary Outcome Measure Information:
Title
Degree of pain
Description
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.
Time Frame
1 month
Title
Rate of inflammation
Description
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
Time Frame
1 month
Title
Rate of Infection
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Axial and coronal computed tomography
Description
Degree of bone plate stability
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed K Allam, Ass prof
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
3111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mandibular Reconstruction Bone Plate

We'll reach out to this number within 24 hrs