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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 20
- Primary Endpoint
- Biting force
Study Overview
Brief Summary
Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures.
Detailed Description
Evaluating the biting force after using 2.0 mm single locking miniplate versus 2.0 mm two conventional non-locking miniplates in the management of parasymphyseal fracture in patients with two-line mandibular fractures.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Contra-lateral unfavorable non-comminuted simple or compound mandibular fracture in the parasymphyseal and angle regions.
- •Fractures amenable to treatment using intra oral approach.
Exclusion Criteria
- •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.
Arms & Interventions
Locking miniplate
The 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.
Intervention: 2.0 single locking miniplates (Procedure)
Non-locking miniplates
The 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.
Intervention: 2.0 single locking miniplates (Procedure)
Outcomes
Primary Outcomes
Biting force
Time Frame: 6 months
Biting force will be measured using occlusal biting force meter (Higher biting force record is better)
Secondary Outcomes
- Stability of fractured segments(6 weeks)
- Pain intensity(10 days)
- Paraesthesia(6 months)
- Hardware failure(6 months)
- Wound dehiscence(6 months)
- Occlusion(6 months)
- Infection(6 months)
Investigators
Hany Abdelkader Hussein
Principal Investigator
Cairo University