Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture

NCT04860427 | Unknown

• 1 other identifier: IRB NO 00010556-IORG 0008839
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture of Condylar Process

Outcome Measures

Primary Outcomes (7)

• comparison of functional mandibular movement between the two groups

  the change mandibular movement in mm

  preopertive, 1 week, 1month , 3 months , 6months

• 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

• comparison of helikmo index between the two groups

  the change in helikmo index score

  preopertive, 1 week, 1month , 3 months , 6months

• 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

• 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.

• 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.

• bone density change comparison between the two groups

  assessment with CT in Hounsfield value measurements.

  1 day postoperative, 1month and 3months

Secondary Outcomes (3)

• Transmasseteric Anteroparotid surgical approach

  intraopertive

• the stress on plates by using finite element analysis

  immediate postopertive

• the displacement (micromotion)

  immediate postoperative

Study Arms (2)

Trapezoidal condylar plate

ACTIVE COMPARATOR

Trapezoidal condylar plate open reduction and internal fixation of subcondylar fractures

Device: trapezoidal condylar plate

two miniplates

ACTIVE COMPARATOR

two miniplates open reduction and internal fixation of subcondylar fractures

Device: two miniplates

Interventions

trapezoidal condylar plate DEVICE

trapezoidal condylar plate open reduction and fixation

Trapezoidal condylar plate

two miniplates DEVICE

two miniplates open reduction and fixation

two miniplates

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Mona Oraby

Alexandria, 25588, Egypt

RECRUITING

Study Officials

• nagy el prince, professor

  oral and maxillofacial surgery, alexanderia university

  STUDY CHAIR

Central Study Contacts

mona oraby, ass. lect.

CONTACT

00201000775330; drmonasamy@gmail.com

mohamed mekky, ass. lect.

CONTACT

00201211332210; mastermekky@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer, oral and maxillofacial surgery department

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 27, 2021
• Study Start: June 10, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 15, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)