[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606741":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":20,"responsibleParty":36,"collaborators":38,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":7,"enrollmentInfo":51,"targetDuration":7,"studyType":54,"phases":7,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Bioceramed","INDUSTRY",null,[9],{"name":10,"affiliation":11,"role":12},"João Botelho","Egas Moniz School of Health and Science Caparica","PRINCIPAL_INVESTIGATOR",[14],{"name":15,"role":16,"phone":17,"phoneExt":18,"email":19},"Alexandre Barros","CONTACT","253 573 460","+351","info@bioceramed.com",[21],{"facility":11,"status":22,"city":23,"state":7,"zip":7,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"RECRUITING","Lisbon","Portugal","PT",{"type":27,"coordinates":28},"Point",[29,30],-9.1498,38.72509,{"lat":30,"lon":29},[33],{"name":10,"role":16,"phone":34,"phoneExt":18,"email":35},"212 946 840","egasmoniz@egasmoniz.edu.pt",{"type":37,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[39],{"name":40,"class":41},"Egas Moniz - Cooperativa de Ensino Superior, CRL","OTHER","100606741","evaluation-of-the-safety-and-performance-of-the-neobone-a-prospective-observational-study-in-dental-area-100606741",false,"NCT07179497","Evaluation of the Safety and Performance of the Neobone®: A Prospective Observational Study in Dental Area","NeoDent01","Inclusion Criteria:\n\n* Adult males or females (age \\> 18 years old);\n* Patients who are able to sign an informed consent form (for data collection);\n* Patients undergoing reconstructive dental surgery and indicated for the use of Neobone®;\n\nExclusion Criteria:\n\n* Patients who are unable to understand consent and the objectives of the study;\n* Signs of local or systemic acute\u002F active or chronic infections;\n* Metabolic affections;\n* Severe degenerative diseases, conditions in which general bone grafting is not advisable;\n* Implementation sites that allow product migration;\n* Conditions which require structural support in the skeletal system;\n* Conditions where the implantation site is unstable and not rigidly fixated;\n* Sensibility to the implantable materials;\n* Known hypersensitivity to the implant material.","ALL","18 Years",{"count":52,"type":53},66,"ESTIMATED","OBSERVATIONAL","This study aims to collect real-world clinical data to gather information on the performance and safety of the Neobone® when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation.",[57],"Bone Augmentation",[59,60,61,62,63,64,65,66,67,68],"prospective observational clinical study","bone substitute","bone defects","hydroxyapatite and beta tricalcium phosphate","Neobone®","real-world clinical data","safety","performance","medical device","reconstructive dental surgeries","2026-06-17",{"date":71,"type":72},"2026-06-18","ACTUAL",{"date":74,"type":72},"2025-10-06",{"date":76,"type":53},"2027-10",{"name":5,"class":6},1]