[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602626":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":53,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Medipol University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Custom-made positioning appliance-assisted mandibular segment repositioning","EXPERIMENTAL","Patients receive a custom-made positioning appliance designed via STL-based planning and manufactured using 3D printing. The appliance is used to guide the proximal mandibular segment during sagittal split ramus osteotomy on one side of the mandible, aiming to improve positional accuracy.",[13],"Procedure: Custom-made positioning appliance-assisted mandibular segment repositioning",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Manual Positioning","ACTIVE_COMPARATOR","On the contralateral side of the mandible, the proximal segment is positioned manually by the surgeon using standard visual and tactile feedback during sagittal split ramus osteotomy, without a guiding appliance.",[19],"Procedure: Conventional Manual Positioning",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","A patient-specific surgical guide designed using STL-based digital planning in Blender and produced via 3D printing with biocompatible surgical resin (Formlabs SLA printer). Used to guide and stabilize the proximal mandibular segment during sagittal split ramus osteotomy.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The proximal mandibular segment is positioned manually by the surgeon based on visual and tactile feedback without the use of a positioning guide. This technique represents the standard method in sagittal split ramus osteotomy.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Sümer Münevveroğlu, D.D.S., Ph.D.","CONTACT","00905386013666","sumer.munevveroglu@medipol.edu.tr",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":25,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Istanbul Medipol University, Medipol Mega University Hospital","RECRUITING","Istanbul","Bağcılar","34218","Turkey (Türkiye)",{"type":44,"coordinates":45},"Point",[46,47],28.94966,41.01384,{"lat":47,"lon":46},[50,51],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"name":31,"role":52,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Sümer Münevveroğlu","Assistant Professor","100602626","patient-specific-vs-conventional-positioning-in-sagittal-split-ramus-osteotomy-100602626",false,"NCT07125963","Patient-Specific vs. Conventional Positioning in Sagittal Split Ramus Osteotomy","Comparison of a Patient-Specific Proximal Segment Positioning Appliance and the Conventional Method in Sagittal Split Ramus Osteotomy","Inclusion Criteria:\n\n* Patients scheduled to undergo bilateral sagittal split ramus osteotomy as part of orthognathic surgery\n* Age ≥ 18 years\n* Availability of preoperative and postoperative CT scans\n* Consent to participate in the study\n\nExclusion Criteria:\n\n* History of previous mandibular surgery\n* Craniofacial syndromes or congenital deformities\n* Incomplete radiological records","ALL","18 Years",{"count":67,"type":68},30,"ESTIMATED","INTERVENTIONAL",[71],"NA","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 due to dentofacial deformities. The results are expected to provide high-level clinical evidence for the reliability of patient-specific appliances in orthognathic surgery.",[74],"Dentofacial Deformities",[76,77,78,79,80],"Sagittal Split Ramus Osteotomy","Orthognathic Surgery","3D Surgical Planning","Patient-Specific Guide","Proximal Segment Position","2025-08-09",{"date":83,"type":84},"2025-08-15","ACTUAL",{"date":86,"type":84},"2024-01-25",{"date":88,"type":68},"2026-10-30",{"name":55,"class":6},1]