Back to resultsA New Surgical Approach to Treat Medial or Low Condylar Fractures
Primary Purpose
Fracture of Condylar Process
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the minor approach
Sponsored by
About this trial
This is an interventional treatment trial for Fracture of Condylar Process focused on measuring medial or low condylar fractures, the minor parotid anterior approach, the retromandibular approach
Eligibility Criteria
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
Sites / Locations
- West China College of Stomatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
the minor approach group
control group
Arm Description
Thirty-six patients (the minor parotid anterior approach group) were treated with minor parotid anterior approach
24 patients (control group) were treated with the retromandibular approach
Outcomes
Primary Outcome Measures
the number of participants with facial nerve injury
to explore whether the minor parotid anterior approach could prevent facial nerve injury.
Secondary Outcome Measures
Full Information
NCT ID
NCT01851031
First Posted
April 27, 2013
Last Updated
May 8, 2013
Sponsor
West China College of Stomatology
1. Study Identification
Unique Protocol Identification Number
NCT01851031
Brief Title
A New Surgical Approach to Treat Medial or Low Condylar Fractures
Official Title
A New Surgical Approach to Treat Medial or Low Condylar Fractures:The Minor Parotid Anterior Approach
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China College of Stomatology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Condylar Process
Keywords
medial or low condylar fractures, the minor parotid anterior approach, the retromandibular approach
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the minor approach group
Arm Type
Experimental
Arm Description
Thirty-six patients (the minor parotid anterior approach group) were treated with minor parotid anterior approach
Arm Title
control group
Arm Type
Other
Arm Description
24 patients (control group) were treated with the retromandibular approach
Intervention Type
Procedure
Intervention Name(s)
the minor approach
Other Intervention Name(s)
the minor parotid anterior approach
Intervention Description
Thirty-six patients (the minor approach group) were treated with minor parotid anterior approach
Primary Outcome Measure Information:
Title
the number of participants with facial nerve injury
Description
to explore whether the minor parotid anterior approach could prevent facial nerve injury.
Time Frame
from 3 months to 1 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Hou, DMD
Organizational Affiliation
West China College of Stomatology
Official's Role
Study Chair
Facility Information:
Facility Name
West China College of Stomatology
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
19231779
Citation
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.
Results Reference
result
PubMed Identifier
24405647
Citation
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.
Results Reference
derived
Learn more about this trial
A New Surgical Approach to Treat Medial or Low Condylar Fractures
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