Treatment of Diacapitular Condylar Fractures

Completed

• Conditions: Mandibular Fractures
• Interventions: Procedure: The supratemporalis approach

• Registration Number: NCT02466269
• Lead Sponsor: Hui Li

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 Timeline

• Study Start: 2014-08
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-08
• Study First Posted: 2015-06-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• clinical and radiographical diagnosis of DFs;

Exclusion Criteria

1. condylar fractures with undisplaced fractures;
2. Fractures without the reduction of the condylar height;
3. A obvious scar at the temporal region, affecting the placement of the original incision.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the preauricular approach	The supratemporalis approach	A classic preauricular incision was used to treat diacapitular condylar fractures

Primary Outcome Measures

Name	Time	Method
Change from facial nerve function at 24 hours postoperatively	24 hours	The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
Change from facial nerve function at 1 week postoperatively	1 week	The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
Change from facial nerve function at 3 months postoperatively	3 months	The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
Change from facial nerve function at 6 months postoperatively	6 months	The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.
Change from facial nerve function at 12 months postoperatively	12 months	The patients were instructed to raise their eyebrows, wrinkle the forehead, gently close the eyes, blow the cheek and smile. Paralysis of the facial nerve was deemed to have occurred if these motions were not achieved.