[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643148":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":63,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":25,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Değirmenci Otomotiv ve Metal Endüstri A.Ş.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BIODENTOSS Cohort","EXPERIMENTAL","This cohort includes participants receiving BIODENTOSS bone-level dental implants (conical or cylindrical models) and compatible superstructures for the restoration of missing teeth. Patients will undergo standard surgical implantation followed by prosthetic restoration at 3 to 4 months post-implantation. Safety and efficacy outcomes-including implant survival\u002Fsuccess rates, stability, marginal bone loss, chewing function, and oral health-related quality of life-will be monitored prospectively across a 24-month follow-up period. Data collected for this cohort will be analyzed and reported independently via descriptive and longitudinal statistics, with no statistical comparison intended against other cohorts.",[13],"Device: BIODENTOSS Bone-Level Dental Implant and Superstructures",{"label":15,"type":10,"description":16,"interventionNames":17},"DWC Cohort","This cohort includes participants receiving DWC bone-level dental implants (cylindrical or active threaded) and compatible superstructures for the restoration of missing teeth. Patients will undergo standard surgical implantation followed by prosthetic restoration at 3 to 4 months post-implantation. Safety and efficacy outcomes-including implant survival\u002Fsuccess rates, stability, marginal bone loss, chewing function, and oral health-related quality of life-will be monitored prospectively across a 24-month follow-up period. Data collected for this cohort will be analyzed and reported independently via descriptive and longitudinal statistics, with no statistical comparison intended against other cohorts.",[18],"Device: DWC Bone-Level Dental Implant and Superstructures",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","BIODENTOSS Bone-Level Dental Implant and Superstructures","Surgical placement of CE-marked BIODENTOSS bone-level dental implants, available in conical or cylindrical models, with diameters ranging from 3.4 mm to 6.0 mm and lengths from 7.5 mm to 13 mm. Implants feature an SLA (Sandblasted, Large-grit, Acid-etched) surface texture and a 22-degree conical internal hex connection. Following an osseointegration period, prosthetic restoration will be completed using compatible superstructures, including cover screws, healing abutments, and various types of prosthetic abutments based on clinical indications.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"DWC Bone-Level Dental Implant and Superstructures","Surgical placement of CE-marked DWC bone-level dental implants, available in cylindrical or active threaded models, with diameters ranging from 3.3 mm to 4.8 mm and lengths from 8 mm to 15 mm. Implants feature an SLA (Sandblasted, Large-grit, Acid-etched) surface texture and a 22-degree conical internal hex connection. Following an osseointegration period, prosthetic restoration will be completed using compatible superstructures, including cover screws, healing abutments, and various types of prosthetic abutments based on clinical indications.",[15],[31],{"name":32,"affiliation":33,"role":34},"Abdullah Kalayci, Professor","Selcuk University Faculty of Dentistry","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Abdullah Sari, Met. Eng.","CONTACT","+90 (332) 516 16 91","kaliteyonetimi@dome.com.tr",[42],{"facility":43,"status":44,"city":45,"state":25,"zip":46,"country":47,"countryCode":25,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Selcuk University, Faculty of Dentistry, Dept. of Oral and Maxillofacial Surgery.","RECRUITING","Konya","42130","Turkey (Türkiye)",{"type":49,"coordinates":50},"Point",[51,52],32.48464,37.87135,{"lat":52,"lon":51},[55,58,61],{"name":32,"role":38,"phone":56,"phoneExt":25,"email":57},"+90 (536) 543 25 87","abdullahkalayci@hotmail.com",{"name":59,"role":60,"phone":25,"phoneExt":25,"email":25},"Serhan Akman, Professor","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":25,"phoneExt":25,"email":25},"Tuba Yilmaz Savas, Asst. Prof.",{"type":64,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":75,"type":76},80,"ESTIMATED","INTERVENTIONAL",[79],"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.",[82,83],"Tooth Loss","Edentulism",[85,86,87,88,89],"Post-Market Clinical Follow-Up (PMCF)","Dental Implants","Osseointegration","Implant Stability","Marginal Bone Loss (MBL)","2026-06-04",{"date":92,"type":93},"2026-06-08","ACTUAL",{"date":95,"type":93},"2024-12-11",{"date":97,"type":76},"2028-07-31",{"name":5,"class":6},1]