[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656584":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":16,"studyPopulation":19,"armGroups":20,"interventions":16,"overallOfficials":16,"centralContacts":24,"locations":30,"responsibleParty":47,"collaborators":16,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":16,"eligibilityCriteria":54,"healthyVolunteers":51,"sex":55,"minAge":56,"maxAge":16,"enrollmentInfo":57,"targetDuration":16,"studyType":60,"phases":16,"briefSummary":61,"conditions":62,"keywords":16,"overallStatus":33,"whyStopped":16,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Semmelweis University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Mandibular Condylar Displacement Between Centric Relation and Maximum Intercuspation Measured by Arcus Digma 3 in Millimeters","The three-dimensional spatial discrepancy (shift\u002Fdisplacement) of the mandibular condyle between centric relation (CR) and maximum intercuspation (MIP), measured in millimeters (along the X, Y, and Z spatial coordinates and as a 3D vector length) using the Arcus Digma III mandibular motion alanyzer device .","Baseline (preoperative, within 4 weeks prior to surgery) and at 6 months postoperatively",{"measure":14,"description":15,"timeFrame":12},"Change in Mandibular Maximum Range of Motion Measured by Arcus Digma 3 in Millimeters","Mandibular maximum range of motion, including maximum mouth opening, protrusion, and right and left lateral excursions, recorded in millimeters using the Arcus Digma 3.",null,{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":6,"timePerspective":18,"maskingInfo":16},"PROSPECTIVE","The study population consists of adult male and female patients diagnosed with skeletal dentofacial deformities who are referred to and treated at the Department of Pediatric Dentistry and Orthodontics in collaboration with the Department of Oro-Maxillofacial Surgery and Stomatology at Semmelweis University (Budapest, Hungary). Eligible participants are consecutive patients undergoing combined orthodontic and orthognathic surgical treatment who fulfill the predefined inclusion criteria and agree to participate in the prospective functional evaluation of the temporomandibular joint and mandibular kinematics.",[21],{"label":22,"type":16,"description":23,"interventionNames":16},"Orthognathic Surgery Cohort","Adult patients diagnosed with dentofacial deformities undergoing combined orthodontic and orthognathic surgical treatment (e.g., bilateral sagittal split osteotomy, Le Fort I osteotomy, or bimaxillary surgery). Participants undergo preoperative and postoperative clinical and functional assessments of the temporomandibular joint (TMJ), including mandibular motion, condylar position analysis, and evaluation of temporomandibular signs and symptoms.",[25],{"name":26,"role":27,"phone":28,"phoneExt":16,"email":29},"Lorincz Gergely, medical","CONTACT","+36306640386","lorincz.gergely@semmelweis.hu",[31],{"facility":32,"status":33,"city":34,"state":16,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Semmelweis University Department of Paediatric Dentistry and Orthodontics","RECRUITING","Budapest","1088","Hungary","HU",{"type":39,"coordinates":40},"Point",[41,42],19.04045,47.49835,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":28,"phoneExt":16,"email":29},"Gergely Lorincz, medical",{"type":48,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100656584","evaluation-of-the-effects-of-orthognathic-surgeries-on-the-temporomandibular-joint-using-a-mandibular-movement-analyzer-device-100656584",false,"NCT07828041","Evaluation of the Effects of Orthognathic Surgeries on the Temporomandibular Joint Using a Mandibular Movement Analyzer Device","Inclusion Criteria:\n\n* Age 18 years or older (skeletally mature patients)\n* Severe dentofacial deformity requiring combined orthodontic and orthognathic surgical treatment\n* Presurgical orthodontic preparation completed or scheduled for orthognathic surgery\n* Signed written informed consent prior to study enrollment\n* Ability and willingness to attend all scheduled preoperative and postoperative follow-up visits\n\nExclusion Criteria:\n\n* History of previous orthognathic or major craniofacial surgical interventions\n* Congenital craniofacial anomalies, cleft lip and\u002For palate, or genetic syndromes affecting the musculoskeletal or facial skeleton\n* Pre-existing severe degenerative temporomandibular joint disease (e.g., advanced osteoarthritis, idiopathic condylar resorption, or ankylosis)\n* Systemic rheumatologic, autoimmune, or connective tissue disorders affecting bone and joint metabolism\n* Active neurological or neuromuscular disorders affecting jaw movement or motor control\n* Current use of medications significantly altering bone metabolism or neuromuscular function\n* Pregnancy or lactation at the time of enrollment\n* Severe unmanaged bruxism or acute trauma to the maxillofacial region within the past 12 months","ALL","18 Years",{"count":58,"type":59},50,"ESTIMATED","OBSERVATIONAL","Condylar position and mandibular motion assessment with digital facebows Arcus Digma III before and after orthognathic surgery.",[63,64],"TMD\u002FOrofacial Pain","Malocclusions","2026-09-21",{"date":67,"type":68},"2026-09-24","ACTUAL",{"date":70,"type":68},"2024-09-18",{"date":72,"type":59},"2027-12-31",{"name":5,"class":6},1]