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NCT04729036 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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