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Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture

Primary Purpose

Fracture of Condylar Process

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
trapezoidal condylar plate
two miniplates
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture of Condylar Process

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1- Medically fit patients free from relevant conditions that contraindicate surgery.

    2- Patients with age ranged from 20-40 years old. 3- Patients suffering from displaced extracapsular mandibular subcondylar fracture indicated for open reduction including Difficulty of obtaining adequate occlusion by closed method, Radiological signs of the following

    1. Deviation of the fragment from the axis of the ascending ramus in medial or lateral direction more than 10°.(22)
    2. Shortening of the ascending ramus ≥ 2 mm measured from the roof of glenoid fossa to the inferior border of the ascending ramus of the mandible.(22)
    3. Dislocation of the condyle from the glenoid fossa.(48)

      Exclusion Criteria:

  • 1. Patients who were not able to follow the information given or to make a decision themselves due to mental or other problems.

    2. Any absolute contraindication for surgery. 3. Patient with undisplaced condylar fractures that doesn't cause malocclusion or loss of facial heightening and can be treated conservatively.

Sites / Locations

  • Mona OrabyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Trapezoidal condylar plate

two miniplates

Arm Description

Trapezoidal condylar plate open reduction and internal fixation of subcondylar fractures

two miniplates open reduction and internal fixation of subcondylar fractures

Outcomes

Primary Outcome Measures

comparison of functional mandibular movement between the two groups
the change mandibular movement in mm
comparison of occlusion between the two groups
the change in occlusion intercuspation assessed visually by the surgeon and by asking the patient
comparison of helikmo index between the two groups
the change in helikmo index score
comparison in pain between the two groups
the change in pain value with Visual analogue Scale With a visual analogue scale (VAS) with values from 0 (no pain) to 10 (strongest pain or discomfort)
comparison in ramus height shortening between the two groups
radiographically: assess the adequacy of reduction by th change in ramus height in mm
comparison in condylar angulation between the two groups
radiographically: assess the adequacy of reduction by measuring the change in condylar angulation
bone density change comparison between the two groups
assessment with CT in Hounsfield value measurements.

Secondary Outcome Measures

Transmasseteric Anteroparotid surgical approach
To evaluate the Transmasseteric Anteroparotid surgical approach for the subcondylar fracture regarding the time taken to reach the fracture line and convenience of the approach.
the stress on plates by using finite element analysis
stress values (Mpa) were obtained in this study for each of the two models during load application
the displacement (micromotion)
the amount of vertical displacement induced around the fracture surface (µm)

Full Information

First Posted
April 8, 2021
Last Updated
July 21, 2021
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04860427
Brief Title
Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture
Official Title
Trapezoidal Condylar Plate (TCP) Versus Two Miniplates in Treatment of Subcondylar Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 15, 2021 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Condylar fracture is a common mandibular fracture which accounts for 25-40%. Nowadays the preference started to change towards open reduction because of the late complications that might happen in case of closed treatment. A Transmasseteric Anteroparotid (TMAP) approach for open reduction and internal fixation of condylar fractures overcomes the problems of difficult access and facial nerve injury risk of other conventional approaches. Different plating options are available for internal fixation of the condyle and subcondylar region. Trapezoidal Condylar Plates (TCP) specifically developed for the osteosynthesis of low and high subcondylar fracture. These plates were designed to closely follow the tensile strain lines along the rim of the sigmoid notch anteriorly combined with a posterior arm to parallel the condylar axis free of harmful bending strains.
Detailed Description
Background: Condylar fracture is a common mandibular fracture which accounts for 25-40%. It is the most controversial fractures regarding diagnosis and management. For several years, closed reduction has been preferred over open reduction to avoid surgical complications. Nowadays the preference started to change towards open reduction because of the late complications that might happen in case of closed treatment. A Transmasseteric Anteroparotid (TMAP) approach for open reduction and internal fixation of condylar fractures overcomes the problems of difficult access and facial nerve injury risk of other conventional approaches. Different plating options are available for internal fixation of the condyle and subcondylar region. Trapezoidal Condylar Plates (TCP) specifically developed for the osteosynthesis of low and high subcondylar fracture. These plates were designed to closely follow the tensile strain lines along the rim of the sigmoid notch anteriorly combined with a posterior arm to parallel the condylar axis free of harmful bending strains. Aim: Our aim in this study is to assess the use of TCP in the subcondylar fracture in comparison to the use of conventional two miniplates method. Materials and methods: This prospective randomized clinical trial will enroll 20 patients with subcondylar fracture indicated for open reduction and internal fixation. Group A will undergo fixation with TCP and group B will have two miniplates fixation. Both groups will have Transmasseteric Anteroparotid approach. Results: The results of the two groups will be compared clinically and radiographically. Keywords: Subcondylar fracture, Trapezoidal condylar plate, two miniplates, open treatment for condyle, geometric subcondylar plates, transmasseteric anteroparotid approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Condylar Process

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Trapezoidal condylar plate
Arm Type
Active Comparator
Arm Description
Trapezoidal condylar plate open reduction and internal fixation of subcondylar fractures
Arm Title
two miniplates
Arm Type
Active Comparator
Arm Description
two miniplates open reduction and internal fixation of subcondylar fractures
Intervention Type
Device
Intervention Name(s)
trapezoidal condylar plate
Intervention Description
trapezoidal condylar plate open reduction and fixation
Intervention Type
Device
Intervention Name(s)
two miniplates
Intervention Description
two miniplates open reduction and fixation
Primary Outcome Measure Information:
Title
comparison of functional mandibular movement between the two groups
Description
the change mandibular movement in mm
Time Frame
preopertive, 1 week, 1month , 3 months , 6months
Title
comparison of occlusion between the two groups
Description
the change in occlusion intercuspation assessed visually by the surgeon and by asking the patient
Time Frame
preopertive, 1 week, 1month , 3 months , 6months
Title
comparison of helikmo index between the two groups
Description
the change in helikmo index score
Time Frame
preopertive, 1 week, 1month , 3 months , 6months
Title
comparison in pain between the two groups
Description
the change in pain value with Visual analogue Scale With a visual analogue scale (VAS) with values from 0 (no pain) to 10 (strongest pain or discomfort)
Time Frame
preopertive, 1 week, 1month
Title
comparison in ramus height shortening between the two groups
Description
radiographically: assess the adequacy of reduction by th change in ramus height in mm
Time Frame
1 day, 3 months, 6 months.
Title
comparison in condylar angulation between the two groups
Description
radiographically: assess the adequacy of reduction by measuring the change in condylar angulation
Time Frame
1 day, 3 months, 6 months.
Title
bone density change comparison between the two groups
Description
assessment with CT in Hounsfield value measurements.
Time Frame
1 day postoperative, 1month and 3months
Secondary Outcome Measure Information:
Title
Transmasseteric Anteroparotid surgical approach
Description
To evaluate the Transmasseteric Anteroparotid surgical approach for the subcondylar fracture regarding the time taken to reach the fracture line and convenience of the approach.
Time Frame
intraopertive
Title
the stress on plates by using finite element analysis
Description
stress values (Mpa) were obtained in this study for each of the two models during load application
Time Frame
immediate postopertive
Title
the displacement (micromotion)
Description
the amount of vertical displacement induced around the fracture surface (µm)
Time Frame
immediate postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1- Medically fit patients free from relevant conditions that contraindicate surgery. 2- Patients with age ranged from 20-40 years old. 3- Patients suffering from displaced extracapsular mandibular subcondylar fracture indicated for open reduction including Difficulty of obtaining adequate occlusion by closed method, Radiological signs of the following Deviation of the fragment from the axis of the ascending ramus in medial or lateral direction more than 10°.(22) Shortening of the ascending ramus ≥ 2 mm measured from the roof of glenoid fossa to the inferior border of the ascending ramus of the mandible.(22) Dislocation of the condyle from the glenoid fossa.(48) Exclusion Criteria: 1. Patients who were not able to follow the information given or to make a decision themselves due to mental or other problems. 2. Any absolute contraindication for surgery. 3. Patient with undisplaced condylar fractures that doesn't cause malocclusion or loss of facial heightening and can be treated conservatively.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mona oraby, ass. lect.
Phone
00201000775330
Email
drmonasamy@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed mekky, ass. lect.
Phone
00201211332210
Email
mastermekky@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nagy el prince, professor
Organizational Affiliation
oral and maxillofacial surgery, alexanderia university
Official's Role
Study Chair
Facility Information:
Facility Name
Mona Oraby
City
Alexandria
ZIP/Postal Code
25588
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mona oraby, ass. lect.
Phone
01000775330
Email
drmonasamy@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture

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