A New Surgical Approach to Treat Medial or Low Condylar Fractures

May 8, 2013 updated by: Hou Jia, West China College of Stomatology

A New Surgical Approach to Treat Medial or Low Condylar Fractures:The Minor Parotid Anterior Approach

The aim of the study was to compare the new approach and the retromandibular approach, so that the therapeutic effect and the advantages of the new approach would be clear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sixty patients (72 sides) with medial or low condylar fractures were treated with surgical intervention. Thirty-six patients (42 sides) were treated with minor parotid anterior approach, and the other 24 patients (30 sides) were treated with retromandibular approach. The data about the operations and complications were recorded. The follow-up periods were 3-12 months.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China College of Stomatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 56 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • (1)clinical and imaging diagnosis of medial or low condylar fractures
  • (2)bone fragments that were obviously dislocated, that affected patients appearance and function, requiring surgical intervention
  • (3)no previous surgical treatment

Exclusion Criteria:

  • (1)medial or low condylar fractures without obvious displacement
  • (2)patients who had previously undergone unsuccessful surgery
  • (3)the surgical site had traumatic scar, so the approach could be carried out on the original incision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the minor approach group
Thirty-six patients (the minor parotid anterior approach group) were treated with minor parotid anterior approach
Procedure: the minor approach
Thirty-six patients (the minor approach group) were treated with minor parotid anterior approach
Other Names:
  • the minor parotid anterior approach
Other: control group
24 patients (control group) were treated with the retromandibular approach
Procedure: the minor approach
Thirty-six patients (the minor approach group) were treated with minor parotid anterior approach
Other Names:
  • the minor parotid anterior approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of participants with facial nerve injury
Time Frame: from 3 months to 1 year after surgery
to explore whether the minor parotid anterior approach could prevent facial nerve injury.
from 3 months to 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China College of Stomatology

Investigators

  • Study Chair: Jia Hou, DMD, West China College of Stomatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 27, 2013

First Submitted That Met QC Criteria

May 8, 2013

First Posted (Estimate)

May 10, 2013

Study Record Updates

Last Update Posted (Estimate)

May 10, 2013

Last Update Submitted That Met QC Criteria

May 8, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • houjia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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