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V Shaped Plate Vs Champy Technique in Mandibular Angle Fractures

Primary Purpose

Fractures, Bone

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Open reduction and internal fixation of mandibular angle fracture using V shaped plate
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractures, Bone focused on measuring champy, angle fracture

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with unilateral angle fracture. Patients free from any systemic diseases that affect bone healing. No sex predilection. Age 18-50 Exclusion criteria: Comminuted angle fractures. Infected angle fracture. Bilateral angle fracture. Patients with any systemic diseases that affect bone healing.

Sites / Locations

  • Faculty of Dentistry , Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

V shaped plate

champy technique

Arm Description

its a new plate that have been used in fixation of fractures in various areas of the mandible,V shaped plate was used in the treatment of three angle fracture cases which provided the advantage of including both lines of osteosynthesis which are the superior border and the lateral surface of the external oblique ridge using one plate.

champy technique is one of the standard methods that are used in fixation of mandibular angle fractures by applying a mini-plate in the superior border of the external oblique ridge.

Outcomes

Primary Outcome Measures

proper occlusion
It's Clinically assessed outcome. Follow up will be carried out immediate post-operative (after1 week), 3months and after 6 months for general clinical assessment of the patient including proper occlusion.

Secondary Outcome Measures

condylar position
C.T scan will be taken post operatively after periods of 1week and 6 months to measure condylar position by specialized (software mimics) C.T superimposition.

Full Information

First Posted
July 6, 2023
Last Updated
August 17, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06005467
Brief Title
V Shaped Plate Vs Champy Technique in Mandibular Angle Fractures
Official Title
The Effect of (v) Shaped Plate on Occlusion and Condylar Position Compared to Champy Technique in Fixation of Mandibular Angle Fracture (Randomized Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
assessing fixation of mandibular angle fracture using two different mini plates, the standard champy technique and the new V shaped plate with comparing occlusion and condylar position between the two plates.
Detailed Description
The mandible is one of the most frequent bones of the face that is susceptible to fractures because its prominent position, as it comes in the second place after nasal fractures . Mostly, such fractures are a result of trauma caused by vehicle accidents, physical altercations, industrial accidents, falls, and contact sports, males usually suffer from mandibular fractures more than females. The angle of the mandible is the most frequent area of the mandible to be fractured after the body, the reasons behind that is the presence of a third molar especially if it was impacted one which weakens the region even more, another reason is the existence of a very thin cross sectional area compared to the anterior parts of the mandible. Most common causes of mandibular angle fractures are motor vehicle collisions and assaults or altercations. Therefore, the aim of this study is to evaluate a novel method which is using a (v) shaped plate in fixation of mandibular angle fracture, The new (v) shaped plate have provided easy reduction and stabilized fixation along both sides of the fracture, as it has two arms that can be easily adjusted over the angle of the mandible covering both lines of osteosynthesis along the superior border and lateral surface of the external oblique ridge using a single plate. Although champy technique has been proven to be successful way for treating angle fractures with low complication rates it covers only one line of osteosynthesis which is the superior border of external oblique ridge unlike the (v) shaped plate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Bone
Keywords
champy, angle fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
V shaped plate
Arm Type
Experimental
Arm Description
its a new plate that have been used in fixation of fractures in various areas of the mandible,V shaped plate was used in the treatment of three angle fracture cases which provided the advantage of including both lines of osteosynthesis which are the superior border and the lateral surface of the external oblique ridge using one plate.
Arm Title
champy technique
Arm Type
Active Comparator
Arm Description
champy technique is one of the standard methods that are used in fixation of mandibular angle fractures by applying a mini-plate in the superior border of the external oblique ridge.
Intervention Type
Procedure
Intervention Name(s)
Open reduction and internal fixation of mandibular angle fracture using V shaped plate
Intervention Description
its a new plate that have been used in fixation of fractures in various areas of the mandible,V shaped plate was used in the treatment of three angle fracture cases which provided the advantage of including both lines of osteosynthesis which are the superior border and the lateral surface of the external oblique ridge using one plate.
Primary Outcome Measure Information:
Title
proper occlusion
Description
It's Clinically assessed outcome. Follow up will be carried out immediate post-operative (after1 week), 3months and after 6 months for general clinical assessment of the patient including proper occlusion.
Time Frame
1 week- 3 months and 6 months
Secondary Outcome Measure Information:
Title
condylar position
Description
C.T scan will be taken post operatively after periods of 1week and 6 months to measure condylar position by specialized (software mimics) C.T superimposition.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with unilateral angle fracture. Patients free from any systemic diseases that affect bone healing. No sex predilection. Age 18-50 Exclusion criteria: Comminuted angle fractures. Infected angle fracture. Bilateral angle fracture. Patients with any systemic diseases that affect bone healing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rasha Tohamy, BSc.
Phone
01066534079
Ext
+2
Email
rasha.tohamy@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa Hassan, BSc.
Phone
01090101125
Ext
+2
Email
alaa.hassan@dentistry.cu.eg
Facility Information:
Facility Name
Faculty of Dentistry , Cairo university
City
Cairo
ZIP/Postal Code
12311
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36896057
Citation
Bhagat MJA, Durairaj D, Naganathan V, Nathiya B, Kumar GS, Mariam S. Application of Anatomically Designed 2-Dimensional V Plate in Management of Mandible Fracture: A Pilot Study. J Maxillofac Oral Surg. 2022 Dec;21(4):1363-1368. doi: 10.1007/s12663-021-01558-5. Epub 2021 Apr 23.
Results Reference
background
PubMed Identifier
28913310
Citation
Lee JH. Treatment of Mandibular Angle Fractures. Arch Craniofac Surg. 2017 Jun;18(2):73-75. doi: 10.7181/acfs.2017.18.2.73. Epub 2017 Jun 26.
Results Reference
background

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V Shaped Plate Vs Champy Technique in Mandibular Angle Fractures

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