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RecruitingNot ApplicableNCT07263893

Inter Flex Three Dimensional Plate in Management of Mandibular Fracture RCT

Evaluation of the Efficacy of Custom-Made Inter-flex Three-Dimensional Plate in Treatment of Mandibular Fracture A Randomized Controlled Clinical Trial

Sponsor

Suez Canal University

Enrollment

20 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Mandibular Fracture Treatment

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria4

  • Patients who are suffering from recent, uninfected, and minimally displaced or unfavorable mandibular fractures
  • Adult patients with no gender predilection that agreed to present for follow-up visits for minimum postoperative period of immediate,3 months,6 months.
  • A fracture that demands open reduction and internal fixation
  • Patients under ASA-1 category

Exclusion Criteria5

  • Comminuted, infected mandibular fracture.
  • Pediatric patients below 4 years old and geriatric patients with completely edentulous mouth.
  • Patient with osteoporosis
  • 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)
  • Fractures in completely edentulous patients

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Interventions

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

site with mandibular fracture will be reduced and fixation will be done .visibility using custom made Inter-flex three dimensional plate plates in Group I and fixation using custom made Inter-flex three dimensional according to champ's lines of osteo-synthesis in Group I. closure of the surgical field with vicryl suture material (90% glycolide and 10% L-lactide: Ethicon part of Johnson \& Johnson Int, US.).

Locations(1)

Mataria Teaching Hospital

Cairo, Egypt

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NCT07263893