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Inter Flex Three Dimensional Plate in Management of Mandibular Fracture RCT

RecruitingNAAges 18 Years - 50 YearsAllSuez Canal University
NCT07263893 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if The use of a 3D-designed Inter-flex plate will achieve safe and desirable anatomical \& functional restoration with reduced operative time in mandibular fracture, * Improvement of occlusal and inter-cuspal relation in addition to stabilized intra-fragmentary mobility, * Offer greatest resistance to displacement * shows most favorable biomechanical behavior

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients who are suffering from recent, uninfected, and minimally displaced or unfavorable mandibular fractures 2. Adult patients with no gender predilection that agreed to present for follow-up visits for minimum postoperative period of immediate,3 months,6 months. 3. A fracture that demands open reduction and internal fixation 4. Patients under ASA-1 category Exclusion Criteria: 1. Comminuted, infected mandibular fracture. 2. Pediatric patients below 4 years old and geriatric patients with completely edentulous mouth. 3. Patient with osteoporosis 4. Medical compromised patient (Poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), Recent (\<3 months) MI, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, shock, sepsis, undergoing regularly scheduled dialysis, history (\>3 months) 5. Fractures in completely edentulous patients
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What it tests

  • Group I :site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture
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Where

1 site
Mataria Teaching Hospital
Cairo, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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