A New Surgical Approach to Treat Medial or Low Condylar Fractures

NCT ID: NCT01851031

Last Updated: 2013-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fracture of Condylar Process

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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the minor approach group

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

Group Type EXPERIMENTAL

the minor approach

Intervention Type PROCEDURE

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

control group

24 patients (control group) were treated with the retromandibular approach

Group Type OTHER

the minor approach

Intervention Type PROCEDURE

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

Interventions

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the minor approach

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

Intervention Type PROCEDURE

Other Intervention Names

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the minor parotid anterior approach

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

56 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China College of Stomatology

OTHER

Sponsor Role lead

Responsible Party

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Hou Jia

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jia Hou, DMD

Role: STUDY_CHAIR

West China College of Stomatology

Locations

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West China College of Stomatology

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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Tang W, Gao C, Long J, Lin Y, Wang H, Liu L, Tian W. Application of modified retromandibular approach indirectly from the anterior edge of the parotid gland in the surgical treatment of condylar fracture. J Oral Maxillofac Surg. 2009 Mar;67(3):552-8. doi: 10.1016/j.joms.2008.06.066.

Reference Type RESULT
PMID: 19231779 (View on PubMed)

Hou J, Chen L, Wang T, Jing W, Tang W, Long J, Tian W, Liu L. A new surgical approach to treat medial or low condylar fractures: the minor parotid anterior approach. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Mar;117(3):283-8. doi: 10.1016/j.oooo.2013.11.491. Epub 2013 Nov 18.

Reference Type DERIVED
PMID: 24405647 (View on PubMed)

Other Identifiers

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houjia

Identifier Type: -

Identifier Source: org_study_id

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