A New Surgical Approach to Treat Medial or Low Condylar Fractures
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 27, 2013
CompletedFirst Posted
Study publicly available on registry
May 10, 2013
CompletedMay 10, 2013
May 1, 2013
3.3 years
April 27, 2013
May 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the number of participants with facial nerve injury
to explore whether the minor parotid anterior approach could prevent facial nerve injury.
from 3 months to 1 year after surgery
Study Arms (2)
the minor approach group
EXPERIMENTALThirty-six patients (the minor parotid anterior approach group) were treated with minor parotid anterior approach
control group
OTHER24 patients (control group) were treated with the retromandibular approach
Interventions
Thirty-six patients (the minor approach group) were treated with minor parotid anterior approach
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China College of Stomatology
Chengdu, Sichuan, 610041, China
Related Publications (2)
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.
PMID: 19231779RESULTHou 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.
PMID: 24405647DERIVED
Study Officials
- STUDY CHAIR
Jia Hou, DMD
West China College of Stomatology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 27, 2013
First Posted
May 10, 2013
Study Start
February 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
May 10, 2013
Record last verified: 2013-05