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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04860427
Other study ID # IRB NO 00010556-IORG 0008839
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 10, 2019
Est. completion date September 15, 2021

Study information

Verified date July 2021
Source Alexandria University
Contact mona oraby, ass. lect.
Phone 00201000775330
Email drmonasamy@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date September 15, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
trapezoidal condylar plate
trapezoidal condylar plate open reduction and fixation
two miniplates
two miniplates open reduction and fixation

Locations

Country Name City State
Egypt Mona Oraby Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary comparison of functional mandibular movement between the two groups the change mandibular movement in mm preopertive, 1 week, 1month , 3 months , 6months
Primary comparison of occlusion between the two groups the change in occlusion intercuspation assessed visually by the surgeon and by asking the patient preopertive, 1 week, 1month , 3 months , 6months
Primary comparison of helikmo index between the two groups the change in helikmo index score preopertive, 1 week, 1month , 3 months , 6months
Primary 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) preopertive, 1 week, 1month
Primary comparison in ramus height shortening between the two groups radiographically: assess the adequacy of reduction by th change in ramus height in mm 1 day, 3 months, 6 months.
Primary comparison in condylar angulation between the two groups radiographically: assess the adequacy of reduction by measuring the change in condylar angulation 1 day, 3 months, 6 months.
Primary bone density change comparison between the two groups assessment with CT in Hounsfield value measurements. 1 day postoperative, 1month and 3months
Secondary 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. intraopertive
Secondary 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 immediate postopertive
Secondary the displacement (micromotion) the amount of vertical displacement induced around the fracture surface (µm) immediate postoperative
See also
  Status Clinical Trial Phase
Completed NCT01851031 - A New Surgical Approach to Treat Medial or Low Condylar Fractures N/A