[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wishbone SA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"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":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100545551","evaluation-of-performance-safety-and-benefit-of-the-wishbone-ha-as-bone-graft-substitute-a-pre-market-clinical-investigation-100545551",false,"NCT06383377","Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation","Prospective, Multi-center, Randomized, Single Blinded and Parallel Controlled Clinical Investigation to Assess the Performance, Safety and Benefit of the Wishbone HA Medical Device, a Deproteinized Bovine Bone Material, as a Bone Graft Substitute in the Socket Management Indication Requiring Bone Grafting Procedure Before Implant Placement.","Inclusion Criteria:\n\n* The subject signed the informed consent form;\n* The subject is ≥ 18 and ≤ 80 years old at surgery;\n* The subject is in need of a tooth extraction prior to implant placement;\n* All four bony walls are preserved after extraction;\n* Minimum 8mm height of bone;\n* Minimum 7mm thickness of lingual vestibular;\n* The subject is willing and able to comply with all investigation related procedures (such as exercising oral hygiene and attending all follow-up visits);\n* Full-mouth bleeding score (FMBS) lower than 25%;\n* Full-mouth plaque score (FMPI) lower than 25%.\n\nExclusion Criteria:\n\n* Subject with an acute infection (abscess) at the surgical site;\n* Subject with untreated periodontitis or periodontal disease;\n* Subject with autoimmune diseases or subjects that had received or were currently receiving treatment with antiresorptive drugs (e.g., bisphosphonates), or steroid therapy;\n* Subject who is pregnant or breastfeeding;\n* Subjects is a heavy smoker (\\>10 cigarettes a day);\n* Subject with an inability to conduct basic oral hygiene (poor oral hygiene and motivation);\n* Subject with metabolic diseases (diabetes, hyperparathyroidism, osteomalacia);\n* Subject with severe renal dysfunction and severe liver disease;\n* Subject with known severe osteoporosis;\n* Subject with multiple sclerosis and\u002For acromegaly;\n* Subject follows radiotherapy;\n* Subject with psychiatric disorders or under substance abuse (drug or alcohol);\n* Subject who participates in other clinical trials interfering with the present protocol;\n* Mucosal diseases in the areas to be treated.",true,"ALL","18 Years","80 Years",{"count":21,"type":22},96,"ESTIMATED","INTERVENTIONAL",[25],"NA","This investigation is a pre-market, prospective, multi-center, randomized, single blinded, parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as intended in the filling of extraction sockets to enhance preservation of the alveolar socket.",[28,29],"Bone Regeneration","Safety Issues","RECRUITING","2024-05-28",{"date":33,"type":34},"2024-05-29","ACTUAL",{"date":36,"type":34},"2024-04-26",{"date":38,"type":22},"2030-03-31",{"name":40,"class":41},"Wishbone SA","INDUSTRY",5,""]