A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures.
1 other identifier
observational
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 15, 2024
CompletedFirst Posted
Study publicly available on registry
March 21, 2024
CompletedMarch 21, 2024
March 1, 2024
2.7 years
March 15, 2024
March 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgery Time
measure the time of surgery from incision till closure with minutes
intraoperative
Secondary Outcomes (2)
complication
6 months
fracture stability
6 months
Study Arms (3)
group (I)
ORIF was done using two 2.0 miniplates
Group II
ORIF was done using 2.3 high profile miniplates
Group III
ORIF was done using 3D miniplates.
Interventions
Eligibility Criteria
patients who had suffered from a recent mandibular fractures in the symphyseal or parasymphyseal region which required Open Reduction with Internal Fixation (ORIF)
You may qualify if:
- Patients with symphyseal/ parasymphyseal mandibular fracture.
- Patients presenting within 7 days of trauma.
You may not qualify if:
- Associated fractures that could affect occlusion or dimensions
- Medically compromised patients who are unfit for management under General Anesthesia
- Patients with gross infection at the site of fracture
- Patients not willing to return for follow-up
- Patients with associated bone pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
October 6U
Cairo, 12566, Egypt
Related 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.
PMID: 30739640BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nermine Ramadan Mahmoud, PhD
Associated Professor of oral and maxillofacial surgery, Oral Surgery Department
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor of oral and maxillofacial surgery, Oral Surgery Department
Study Record Dates
First Submitted
March 15, 2024
First Posted
March 21, 2024
Study Start
January 1, 2021
Primary Completion
October 1, 2023
Study Completion
December 1, 2023
Last Updated
March 21, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share