[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585851":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":36,"collaborators":7,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":7,"maxAge":7,"enrollmentInfo":47,"targetDuration":50,"studyType":51,"phases":7,"briefSummary":52,"conditions":53,"keywords":7,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},{"fullName":5,"class":6},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"PROCEDURE","Bimaxillary Osteotomy","Maxillary LeFort I osteotomy and mandible osteotomy (BSSO) without intermediate splint.",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Alessandro Baj, Prof","CONTACT","00393884214136","alessandro.baj@unimi.it",[20],{"facility":21,"status":22,"city":23,"state":23,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"IRCCS Ospedale Galeazzi-Sant'Ambrogio","RECRUITING","Milan","20157","Italy","IT",{"type":28,"coordinates":29},"Point",[30,31],9.18951,45.46427,{"lat":31,"lon":30},[34],{"name":15,"role":16,"phone":35,"phoneExt":7,"email":18},"0039 3884214136",{"type":37,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100585851","splintless-virtual-surgical-plan-with-mandible-first-technique-3d-accuracy-analysis-100585851",false,"NCT06907745","Splintless Virtual Surgical Plan with Mandible-first Technique: 3D Accuracy Analysis","Splintless Virtual Surgical Plan with Mandible-first Technique in Orthognathic Surgery: Tridimensional Accuracy Analysis","MandiFirst","Inclusion Criteria:\n\n* Men and women\n* Age over 18 and under 60\n* Diagnosis of dento-skeletal dysmorphosis involving the middle third and lower part of the face\n* Patients with consent to surgery\n* Patients in good general health according to the evaluation of the PI and on the basis of the anamnesis and clinical examination\n\nExclusion Criteria:\n\n* History of previous maxillomandibular fracture\n* Treatment with anticoagulant drugs\n* Treatment with intravenous bisphosphonates\n* Treatment with anticonvulsants\n* Patient's inability to maintain home hygiene standards in accordance with the study requirements\n* History of drug and\u002For alcohol abuse\n* Chronic corticosteroid therapy\n* Radiotherapy, chemotherapy and\u002For immunosuppressive treatment or radiotherapy in the last 5 years\n* Psychosis\n* Pregnant or breastfeeding\n* Poor compliance\n* Endocrinological disorders in poor pharmacological control\n* Other uncontrolled systemic conditions that preclude performing surgical procedures","ALL",{"count":48,"type":49},28,"ESTIMATED","6 Months","OBSERVATIONAL","Accuracy assessment through three-dimensional superposition of the post-operative volumetric CT and the digital therapeutic project files.",[54],"Dentofacial Deformities","2025-03-26",{"date":57,"type":58},"2025-04-02","ACTUAL",{"date":60,"type":58},"2024-04-24",{"date":62,"type":49},"2025-12-31",{"name":5,"class":6},1]