[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598201":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":43,"responsibleParty":67,"collaborators":32,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":32,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":32,"enrollmentInfo":78,"targetDuration":32,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":59,"whyStopped":32,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"King Abdulaziz University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"2D Surgical Simulation","ACTIVE_COMPARATOR","This group received an orthognathic surgery consultation incorporating two-dimensional images generated from virtual surgical planning. These images illustrated the patient's current skeletal deformity and the anticipated surgical movements, providing a visual aid to enhance understanding and facilitate informed decision-making.",[13],"Combination Product: 2D Visual Representations of Skeletal Movements in Orthognathic Surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"3D Surgical Simulation","EXPERIMENTAL","This group received an orthognathic surgery consultation using 3D-printed anatomical models. The models, representing skeletal Class II and Class III deformities, were customized and modified to simulate osteotomies. During the consultation, these models are used to demonstrate the planned surgical movements, providing patients with a tangible, visual understanding of their condition and the proposed treatment.",[19],"Combination Product: 3D-printed Orthognathic Surgical Simulation",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","3D-printed Orthognathic Surgical Simulation","Two standardized 3D-printed anatomical models were created-one representing skeletal Class II and the other skeletal Class III. Simulated osteotomies, including Le Fort I and Bilateral Sagittal Split Osteotomies, were performed on the models to demonstrate surgical movements. These models are used to help patients visualize the procedures planned for their specific cases.",[15],[27],"3d-printed anatomical models",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"2D Visual Representations of Skeletal Movements in Orthognathic Surgery","Two-dimensional images generated from virtual surgical planning-one depicting a Class II skeletal deformity and the other a Class III malocclusion-are used to illustrate the patient's condition and demonstrate the anticipated surgical movements.",[9],null,[34],{"name":35,"affiliation":36,"role":37},"Razan M Baabdullah, BDS,MS,FRCDC","King Abdulaziz University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery","PRINCIPAL_INVESTIGATOR",[39],{"name":35,"role":40,"phone":41,"phoneExt":32,"email":42},"CONTACT","+96655501567","rmsbaabdullah@kau.edu.sa",[44,57],{"facility":45,"status":46,"city":47,"state":48,"zip":32,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":32},"Razan Baabdullah","COMPLETED","Jeddah","Mecca Region","Saudi Arabia","SA",{"type":52,"coordinates":53},"Point",[54,55],39.18624,21.49012,{"lat":55,"lon":54},{"facility":58,"status":59,"city":47,"state":32,"zip":32,"country":49,"countryCode":50,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"King Abdulaziz University Dental Hospital","RECRUITING",{"type":52,"coordinates":61},[54,55],{"lat":55,"lon":54},[64],{"name":65,"role":40,"phone":66,"phoneExt":32,"email":42},"Razan Baabdullah, BDS, MS, FRCDC","+966 12 640 0000",{"type":37,"investigatorFullName":45,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Assistant professor of oral and maxillofacial surgery Affiliation: King Abdulaziz University","100598201","impact-of-3d-printed-anatomical-model-on-patient-understanding-in-orthognathic-surgery-100598201",false,"NCT07068412","Impact of 3D-Printed Anatomical Model on Patient Understanding in Orthognathic Surgery","Impact of 3D-Printed Anatomical Models on Patient Understanding, Anxiety, Patient-Doctor Relationship, and Overall Satisfaction During the Informed Consent Process in Orthognathic Surgery: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Adult patients (aged 18 and above)\n* Scheduled for orthognathic surgery (specifically double-jaw or triple-jaw procedures)\n\nExclusion Criteria:\n\n* Pediatric patients (under 18 years old)\n* Patients undergoing re-do\u002Frevision surgery\n* Patients with psychiatric disorders\n* Patients receiving only orthodontic treatment\n* Patients undergoing single-jaw surgery","ALL","18 Years",{"count":79,"type":80},60,"ESTIMATED","INTERVENTIONAL",[83],"NA","The goal of this clinical trial is to learn whether using three dimensional (3D)-printed anatomical models improves the informed consent process for participants undergoing orthognathic surgery. The trial also explores how these models affect participants understanding, anxiety, satisfaction, and communication with the surgeon.\n\nThe main questions it aims to answer are:\n\n* Do 3D-printed anatomical models improve participants understanding of their jaw condition and the surgical procedure?\n* Do they reduce participants anxiety before surgery?\n* Do they enhance overall participants satisfaction and the physician-patient relationship?\n\nResearchers compares participants who received standard two dimensional (2D) imaging and verbal explanations with those who received the same information plus 3D-printed jaw models.\n\nParticipants:\n\n* Scheduled for double- or triple-jaw orthognathic surgery\n* Randomly assigned to receive either traditional 2D education or the 3D-printed model intervention\n* Complete a validated questionnaires assessing understanding, anxiety, satisfaction, and doctor-patient communication",[86,87,88,89],"Skeletal Deformities","Orthognathic Surgical Procedures","Anxiety","Patient Education",[91,92,93,94,95,96,97,98,99,100,101],"Skeletal deformities","Skeletal class II","Skeletal class III","Orthognathic surgery","Patient understanding","Patients' satisfaction","Patient-doctor relationship","Anxiety level","anatomical models","3D printed models","Patient education","2025-07-06",{"date":104,"type":105},"2025-07-16","ACTUAL",{"date":107,"type":105},"2025-06-01",{"date":109,"type":80},"2025-08-30",{"name":5,"class":6},2]