Mandibular Angle Fracture and Interframents Gap

Mandibular Fractures Clinical Trial

Official title:

Interfragmentary Gap Discrepancy After Intraoral One-plate Fixation in Mandibular Angle Fracture

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04729036
• Other study ID #: 29/12/2019
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: January 2021
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Twenty-five patients with mandibular angle fracture were subjected to reduction and fixation through intra-oral open reduction and semi-rigid min plate fixation near the superior border of the mandible at Champy's osteosynthesis line. The linear inter-fragmentary gap was measured at the inferior border of the mandible after fixation of the fractured bony segments in the final aligned position immediately postoperative on a panoramic radiograph for the mesio-distal plane and a cone beam computed tomography for the bucco-lingual plane to assess any lingual splay. The healing process was clinically followed for 3 months postoperatively for any complications and/or patient complains

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: February 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• minimally displaced mandibular angle fracture which needed intervention via reduction and fixation *medically free

Exclusion Criteria:

• - Patients with multiple mandibular fractures or patients with concomitant maxillary fracture.

• Patients with severely displaced mandibular angle fracture needing extra-oral open reduction and fixation.

• Medically compromised patients and patients with abnormalities that impair bone healing

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fractures

Intervention

Procedure:
• open reduction and internal fixation
The same surgical team have treated all the patients through open reduction via an intra-oral mucosal flap under general anesthesia with insertion and fixation of a 4-6 holes 2.0 miniplate and 5 mm screws at the superior border of the mandible at Champy's osteosynthesis line

Locations

Country	Name	City	State
Egypt	Fayoum University	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interfragment gap	measure the mesio-distal plane discrepancy in terms of linear inter-fragmentary gap at the inferior border between the fractured mesial and proximal segments by CT	3 months