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Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture

NCT04860427 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-07-22

No results posted yet for this study

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

Interventions

DEVICE

trapezoidal condylar plate

trapezoidal condylar plate open reduction and fixation

DEVICE

two miniplates

two miniplates open reduction and fixation

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • nagy el prince, professor · oral and maxillofacial surgery, alexanderia university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2021-09-01
Completion
2021-09-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04860427 on ClinicalTrials.gov