Clinical trial NCT04860427: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture of Condylar Process
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
  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.

Primary outcomes:
measure: comparison of functional mandibular movement between the two groups
timeFrame: preopertive, 1 week, 1month , 3 months , 6months
measure: comparison of occlusion between the two groups
timeFrame: preopertive, 1 week, 1month , 3 months , 6months
measure: comparison of helikmo index between the two groups
timeFrame: preopertive, 1 week, 1month , 3 months , 6months
measure: comparison in pain between the two groups
timeFrame: preopertive, 1 week, 1month
measure: comparison in ramus height shortening between the two groups
timeFrame: 1 day, 3 months, 6 months.
measure: comparison in condylar angulation between the two groups
timeFrame: 1 day, 3 months, 6 months.
measure: bone density change comparison between the two groups
timeFrame: 1 day postoperative, 1month and 3months
Secondary outcomes:
measure: Transmasseteric Anteroparotid surgical approach
timeFrame: intraopertive
measure: the stress on plates by using finite element analysis
timeFrame: immediate postopertive
measure: the displacement (micromotion)
timeFrame: immediate postoperative
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Mona Oraby
Study officials:
affiliation: oral and maxillofacial surgery, alexanderia university
name: nagy el prince, professor
role: STUDY_CHAIR
References: