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Clinical Trials/NCT04729036
NCT04729036UnknownNot Applicable

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

Fayoum University1 site in 1 country25 target enrollmentStarted: January 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
25
Locations
1
Primary Endpoint
interfragment gap

Study Overview

Brief 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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

interfragment gap

Time Frame: 3 months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shaimaa Mohsen

lecturer of oral and maxillofaciall surgery

Fayoum University

Study Sites (1)

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