Treatment of Diacapitular Condylar Fractures

Mandibular Fractures Clinical Trial

Official title:

A Modified Preauricular Approach to Treat Diacapitular Condylar Fractures: The Supratemporalis Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466269
• Other study ID #: hui_owen
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: October 23, 2017
• Start date: August 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2017
• Source: West China College of Stomatology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fractures

Intervention

Procedure:
• The supratemporalis approach
The supratemporalis approach was applied in treatment of diacapitular condylar fractures

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hui Li	West China College of Stomatology

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from facial nerve function at 24 hours postoperatively	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.	24 hours
Primary	Change from facial nerve function at 1 week postoperatively	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.	1 week
Primary	Change from facial nerve function at 3 months postoperatively	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.	3 months
Primary	Change from facial nerve function at 6 months postoperatively	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.	6 months
Primary	Change from facial nerve function at 12 months postoperatively	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.	12 months