Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-02-08 @ 3:52 PM
Study NCT ID:
NCT02466269
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2015-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Diacapitular Condylar Fractures
Sponsor:
Hui Li
Organization:
Study Overview
Official Title:
A Modified Preauricular Approach to Treat Diacapitular Condylar Fractures: The Supratemporalis Approach
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A new surgical approach, denoted as the supratemporalis approach, was designed to treat diacapitular condylar fractures of the mandibular condyle.This approach prevented facial nerve injury and did not increase the frequency of other complications. Therefore, the investigators suggest this surgical procedure as a routine and safe approach to diacapitular condylar fractures, which can also be applied to temporomandibular joint（TMJ）and to the zygomatic arch.
Detailed Description:
Eighty-four patients (112 sides) with diacapitular condylar fractures were treated surgically. Forty-four patients (64 sides) were treated with the supratemporalis approach, and forty patients (48 sides) were treated with traditional preauricular approach. Data on the surgical procedures and complications were recorded. The follow-up periods were 12 -24months. The evaluated parameters include facial nerve injury，the maximum mouth opening, mandibular movements, occlusion, scar formation，hemorrhage and infection.Seven patients sustained facial nerve paresis in the group treated with the traditional preauricular approach. No case of facial nerve injury was observed in the supratemporalis approach group. No other significant differences were detected between the two groups in the functional and esthetic aspects.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: