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Patient-Specific vs. Conventional Positioning in Sagittal Split Ramus Osteotomy

RecruitingNAAges 18 Years - anyAllSümer Münevveroğlu
NCT07125963 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study aims to evaluate the clinical efficacy and positioning accuracy of a custom-made proximal segment positioning appliance designed for use in sagittal split ramus osteotomy (SSRO). The appliance is produced using STL-based digital planning and 3D printing technologies. In each patient, the appliance is applied to one side of the mandible while the contralateral side is positioned using the conventional manual method. This within-subject design enables direct comparison by eliminating inter-individual anatomical variability. The primary outcome is the accuracy of segment positioning, evaluated by 3D superimposition and deviation analysis of pre- and postoperative STL models. Secondary outcomes include surgical time, ease of use as rated by the surgeon, and postoperative temporomandibular joint symptoms. The study will enroll 30 adult patients undergoing SSRO or double-jaw surgery

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients scheduled to undergo bilateral sagittal split ramus osteotomy as part of orthognathic surgery * Age ≥ 18 years * Availability of preoperative and postoperative CT scans * Consent to participate in the study Exclusion Criteria: * History of previous mandibular surgery * Craniofacial syndromes or congenital deformities * Incomplete radiological records
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What it tests

  • Custom-made positioning appliance-assisted mandibular segment repositioning
  • Conventional Manual Positioning
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Where

1 site
Istanbul Medipol University, Medipol Mega University Hospital
Istanbul, Turkey (Türkiye)
🤝 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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