Single Locking Miniplate and Two Non-locking Miniplates in the Management of Parasymphyseal Fracture
Evaluating Masticatory Biting Force After Using Single Locking Miniplate Versus Two Non-locking Miniplates in the Management of Parasymphyseal Fracture in Patients With Two-line Mandibular Fractures
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
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
First Submitted
Initial submission to the registry
November 12, 2018
CompletedFirst Posted
Study publicly available on registry
November 20, 2018
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedFebruary 19, 2019
February 1, 2019
Same day
November 12, 2018
February 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Biting force
Biting force will be measured using occlusal biting force meter (Higher biting force record is better)
6 months
Secondary Outcomes (7)
Stability of fractured segments
6 weeks
Pain intensity
10 days
Occlusion
6 months
Infection
6 months
Hardware failure
6 months
- +2 more secondary outcomes
Study Arms (2)
Locking miniplate
EXPERIMENTALThe fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge.
Non-locking miniplates
EXPERIMENTALThe fractured segments in the parasymphyseal region will be fixed using 2.0 two non-locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge.
Interventions
The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.
Eligibility Criteria
You may qualify if:
- Contra-lateral unfavorable non-comminuted simple or compound mandibular fracture in the parasymphyseal and angle regions.
- Fractures amenable to treatment using intra oral approach.
You may not qualify if:
- Medically compromised patients who are unfit for the procedure under general anesthesia.
- Patients with comminuted fractures.
- Patients with history of occlusion disturbances or skeletal malocclusion.
- Patients with insufficient dentition to reproduce occlusion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 12, 2018
First Posted
November 20, 2018
Study Start
November 1, 2019
Primary Completion
November 1, 2019
Study Completion
November 1, 2020
Last Updated
February 19, 2019
Record last verified: 2019-02