[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteotomy-le-fort-i\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteotomy-le-fort-i":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100657775","comparing-3d-printed-and-milled-titanium-plates-in-jaw-surgery-le-fort-i-accuracy-and-operative-time-100657775",false,"NCT07841067","Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time","Assessment of the Three-Dimensional Surgical Accuracy and Operative Time of 3D-Printed Versus Milled Patient-Specific Titanium Plates in Le Fort I Osteotomy: A Randomized Clinical Trial","TiPlateRCT","Inclusion Criteria:\n\n* Skeletally mature patients (typically ≥ 18 years old) with fused growth plates.\n* Non-syndromic skeletal Class II or Class III malocclusion requiring a Le Fort I osteotomy (with or without mandibular involvement).\n* Patients with no signs or symptoms of active temporomandibular disorders (TMD).\n* Patients with good oral hygiene and no active periodontal disease that could affect tooth-borne guides.\n* Highly motivated patients.\n\nExclusion Criteria:\n\n* Patients who refused to be included in the research and patients unable to comply with follow up Protocol.\n* Patients with systemic diseases may hinder the normal healing process or render the patient not fit for general anesthesia.\n* Craniofacial anomalies or syndromes (cleft lip\u002Fpalate, syndromic deformities).\n* Previous orthognathic surgery or revision cases.\n* Patients with intra-bony lesions or infections that may retard the osteotomy healing.\n* History of maxillofacial trauma altering anatomy.","ALL","18 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to find out if 3D printed patient-specific titanium plates improve surgical accuracy and decrease operative time compared to milled patient-specific titanium plates in patients having Le Fort I osteotomy for jaw correction. The main questions it aims to answer are:\n\n* Do 3D-printed patient specific titanium plates improve surgical accuracy (as measured by ability to transfer the computer plan to the patient's jaw)?\n* Do 3D-printed patient specific titanium plates decrease operative time when compared to milled patient specific titanium plates? This study will compare two groups of patients. One group will receive 3D printed plates (study group) and the other will receive milled plates (control group) to see if the different methods of making the plates changes the surgical accuracy or operative time.\n\nAll participants in the study will:\n\n* Have Le Fort I osteotomy surgery using patient specific titanium plates (either 3D printed or milled).\n* Have CT scans before and after surgery to evaluate accuracy. Have their operative time recorded.\n* Have a post-surgical follow-up to evaluate healing, stability and orthodontic treatment.",[27,28,29,30],"Malocclusion, Angle Class II","Malocclusion, Angle Class III","Dentofacial Deformities","Osteotomy, Le Fort I",[32,33,29,27,28,34,35],"Orthognathic Surgery","Le Fort I Osteotomy","Milled Titanium Plates","3D Printed Titanium Plates","RECRUITING","2026-09-19",{"date":39,"type":40},"2026-09-25","ACTUAL",{"date":42,"type":21},"2026-10-01",{"date":44,"type":21},"2027-04",{"name":46,"class":47},"Future University in Egypt","OTHER"]