[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555023":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":20,"collaborators":11,"id":22,"slug":23,"hasResults":24,"nctId":25,"briefTitle":26,"officialTitle":26,"acronym":11,"eligibilityCriteria":27,"healthyVolunteers":28,"sex":29,"minAge":30,"maxAge":11,"enrollmentInfo":31,"targetDuration":11,"studyType":34,"phases":35,"briefSummary":37,"conditions":38,"keywords":41,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":11},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Early loading of craniofacial prosthesis","EXPERIMENTAL",null,[13],"Device: Craniofacial implant placement",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Craniofacial implant placement","* Resection of oncologic process or remnants after trauma if necessary\n* Placement of craniofacial implants in the nasal floor and\u002For the temporal bone.\n* Placement of split thickness skin graft around the implants\n* Placement of nose and\u002For ear prosthesis within 3 weeks",[9],{"type":21,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100555023","optimizing-surgical-and-prosthetic-workflow-for-implant-supported-ear-and-nose-prostheses-with-early-loading-and-distant-prosthesis-fabrication-a-prospective-cohort-study-100555023",false,"NCT06506695","Optimizing Surgical and Prosthetic Workflow for Implant-supported Ear and Nose Prostheses With Early Loading and Distant Prosthesis Fabrication: A Prospective Cohort Study","Inclusion Criteria:\n\n* Adult patients with a facial defect in the nasal and\u002For temporal area that will not be repaired with autologous tissue;\n* Adult patients receiving oncological resection or trauma resulting in a facial defect in the nose and\u002For ear that will not be repaired with autologous tissue;\n* Patients who can come to the hospital every week for 6 weeks.\n\nExclusion Criteria:\n\n* Patients with insufficient bone mass for implant placement\n* Patients who cannot come to the hospital for weekly follow-ups\n* Patients that wish an autologous reconstruction\n* Patient is unable to tolerate general anesthesia",true,"ALL","18 Years",{"count":32,"type":33},10,"ESTIMATED","INTERVENTIONAL",[36],"NA","Facial defects created by trauma, oncological procedures or congenital conditions can be repaired with ear, nose and\u002For eye prostheses. These are fixed on intraosseous implants placed in the temporal, nasal and orbital bone. To date, an osseointegration period of 3-6 months is maintained after which the implants are loaded.\n\nThis study aims to achieve two goals:\n\n1. To load the implants with a nose or ear prosthesis within one month (preferably \\\u003C3 weeks). Patients with an orbital prosthesis will not be recruited. In other words, an optimization of an existing protocol will be investigated. The quality of life of the patients as well as possible complications of the implants will be investigated.\n2. Because of the short time between the surgery and the placement of the prosthesis, the prosthesis will be fabricated remotely. This means that the patient will not have to travel to the prosthetist. The feasibility and aesthetics will be analyzed through questionnaires for the patient.",[39,40],"Facial Deformity","Implant Complication",[42,43,44,45,46,47,48],"Facial defect","Facial Prosthesis","Ear prosthesis","Nose prosthesis","Craniofacial implant","Anaplastology","Prosthesis fabrication","NOT_YET_RECRUITING","2024-07-16",{"date":52,"type":53},"2024-07-17","ACTUAL",{"date":55,"type":33},"2024-09-15",{"date":57,"type":33},"2025-12-31",{"name":5,"class":6}]