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Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates

RecruitingNAAges 18 Years - 50 YearsAllMansoura University
NCT07850570 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Mandibular fractures represent a significant portion of maxillofacial trauma, primarily resulting from motor vehicle accidents, interpersonal violence, and sports-related injuries. Achieving successful treatment requires accurate anatomical reduction, stable internal fixation, and restoration of pre-traumatic occlusion and masticatory function . Open reduction and internal fixation (ORIF) using titanium miniplates has long served as the gold standard for mandibular fracture management due to their superior mechanical strength, excellent biocompatibility, and proven structural reliability . Despite their widespread clinical adoption, conventional titanium plates present notable drawbacks. Their high elastic modulus compared to human cortical bone often leads to stress shielding, which can impede normal bone healing and cause local osteopenia .Additionally, titanium hardware can cause tem

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients age ranging from 18 to 50 years. * Unilateral and/or bilateral simple or compound fractures of the mandibular symphysis, parasymphysis or body regions that are displaced and require open reduction with internal fixation. * The fractures must be recent, having occurred no longer than 10 days prior to the surgical treatment. * Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I. Exclusion Criteria: * Patients suffer from pathological fractures. * Comminuted and infected fractures. * Fracture of the atrophic edentulous ridge * Old mandibular fractures (more than 10 days). * Patients with ASA classes II, III, IV, and V.
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What it tests

  • Custom-Made Titanium Plate
  • Custom-Made PEEK Plate
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Where

1 site
Mansoura University, Faculty of Dentistry
Al Mansurah, 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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