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Completed

NCT Number: NCT01851031

A New Surgical Approach to Treat Medial or Low Condylar Fractures

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.

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Key information

Conditions

Fracture of Condylar Process

Age range

5 year–56 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China College of Stomatology

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the minor approach

Procedure

Thirty-six patients (the minor approach group) were treated with minor parotid anterior approach

Other names: the minor parotid anterior approach

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

West China College of Stomatology

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 10, 2013
Registry last updated
May 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.