Mandibular Angle Fracture and Interframents Gap

NCT04729036 | Unknown DMC

• 1 other identifier: 29/12/2019
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Mandibular Fractures

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

mandibular fracture group

Procedure: open reduction and internal fixation

Interventions

open reduction and internal fixation PROCEDURE

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

mandibular fracture group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

. All the patients suffered from minimally displaced mandibular angle fracture which needed intervention via reduction and fixation

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Mandibular Fractures

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of oral and maxillofaciall surgery

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: January 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

EG (1)