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NCT06323122 Clinical Trial

A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures.

Mandibular Fractures Clinical Trial

Official title:
A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures. A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06323122
Other study ID # Plating Techniques 2023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 1, 2023

Study information
Verified date March 2024
Source October 6 University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main goal in management of mandibular fractures is to restore the pre-injury form and function, with the least disability and shortest recovery period.

Description:

Currently there are a diversity of metallic hardware used for fixation of jaw fractures. However, the proper selection of the suitable technique is still a matter of debate. The aim of the current study was to compare between the effect of two miniplates, 2.3 high profile Miniplates and three dimensional (3D) Miniplates for internal fixation treatment of mandibular para-symphyseal fractures.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: 1. Patients with symphyseal/ parasymphyseal mandibular fracture. 2. Patients presenting within 7 days of trauma. Exclusion Criteria: 1. Associated fractures that could affect occlusion or dimensions 2. Medically compromised patients who are unfit for management under General Anesthesia 3. Patients with gross infection at the site of fracture 4. Patients not willing to return for follow-up 5. Patients with associated bone pathology

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 2.0 miniplates
2.0 miniplates
• 2.3 high profile miniplates
2.3 high profile miniplates
• 3D miniplates
3D miniplates

Locations
Country Name City State
Egypt October 6U Cairo

Sponsors (1)
Lead Sponsor Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Hu W, Agrawal M, Thadani S, Mukul SK, Sood R, Patel A, Dhanak R, Tailor S. Comparative evaluation of a single 2.0-mm AO locking reconstruction plate with conventional miniplate osteosynthesis for treatment of linear non-comminuted fractures of symphysis and parasymphsis region of the mandible. J Stomatol Oral Maxillofac Surg. 2019 Feb;120(1):11-15. doi: 10.1016/j.jormas.2018.10.002. Epub 2018 Oct 26. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Surgery Time measure the time of surgery from incision till closure with minutes intraoperative
Secondary complication record the surgical complication operative and postoperative 6 months
Secondary fracture stability measure fracture stability from radiographs 6 months
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