[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Değirmenci Otomotiv ve Metal Endüstri A.Ş.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100643148","pmcf-study-on-the-effectiveness-and-safety-of-biodentoss-and-dwc-dental-implants-and-superstructures-100643148",false,"NCT07633665","PMCF Study on the Effectiveness and Safety of BIODENTOSS® and DWC® Dental Implants and Superstructures","Post-Market Clinical Follow-Up (PMCF) Study on the Effectiveness and Safety of BIODENTOSS® and DWC® Dental Implants and Superstructures","Inclusion Criteria:\n\n* 18 years of age or older,\n* Male or female,\n* Subjects with missing tooth who require dental implant treatment,\n* At least 2 months elapsed since tooth extraction,\n* General health status suitable for implantation,\n* Not legally restricted (e.g., soldier, convict),\n* Provision of signed Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n* Suspected or confirmed pregnancy or breastfeeding,\n* Disorders preventing adequate daily oral hygiene,\n* Hypersensitivity\u002Fallergy to titanium or implant components,\n* Inappropriate interarch relationship or parafunction (e.g., bruxism),\n* Bone\u002Fsoft tissue deficiency requiring augmentation,\n* Active periodontal infection or untreated oral pathologies,\n* Unstable systemic diseases affecting wound healing (e.g., diabetes),\n* Use of immunosuppressive drug therapy due to systemic disorders, organ transplantation, or any other medical conditions,\n* Hematological disorders or current use of anticoagulants (such as Warfarin, dabigatran or related therapies),\n* Presence of osteoporosis and\u002For any disease condition affecting bone metabolism,\n* Presence of an active systemic infection, or any health condition or ongoing treatment (e.g., radiotherapy, bisphosphonate therapy) that contraindicates elective surgery,\n* Recent myocardial infarction or cerebrovascular event,\n* Individuals who consume high doses of alcohol, cigarettes, or tobacco products and are unable to control their usage,\n* Participation in another interventional clinical study.","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"NA","This prospective, single-center, interventional post-market clinical follow-up (PMCF) study aims to evaluate the early-term (24 months post-implantation) safety and efficacy of CE-marked BIODENTOSS® and DWC ® Dental Implants and Superstructures in patients requiring dental restoration for tooth loss.",[26,27],"Tooth Loss","Edentulism",[29,30,31,32,33],"Post-Market Clinical Follow-Up (PMCF)","Dental Implants","Osseointegration","Implant Stability","Marginal Bone Loss (MBL)","RECRUITING","2026-06-04",{"date":37,"type":38},"2026-06-08","ACTUAL",{"date":40,"type":38},"2024-12-11",{"date":42,"type":20},"2028-07-31",{"name":44,"class":45},"Değirmenci Otomotiv ve Metal Endüstri A.Ş.","INDUSTRY",""]