A New Surgical Approach to Treat Medial or Low Condylar Fractures

Fracture of Condylar Process Clinical Trial

Official title:

A New Surgical Approach to Treat Medial or Low Condylar Fractures:The Minor Parotid Anterior Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851031
• Other study ID #: houjia
• Status: Completed
• Phase: N/A
• First received: April 27, 2013
• Last updated: May 8, 2013
• Start date: February 2009
• Est. completion date: June 2012

Study information

• Verified date: May 2013
• Source: West China College of Stomatology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 56 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fracture of Condylar Process
• Fractures, Bone

Intervention

Procedure:
• the minor approach
Thirty-six patients (the minor approach group) were treated with minor parotid anterior approach

Locations

Country	Name	City	State
China	West China College of Stomatology	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China College of Stomatology

Country where clinical trial is conducted

China, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   The West China Hospital of Stomatology has long been ranked as one of the nation's top hospitals in China.