[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545551":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":118,"collaborators":120,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":25,"eligibilityCriteria":135,"healthyVolunteers":136,"sex":137,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":25,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":25,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Wishbone SA","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bio-Oss®","ACTIVE_COMPARATOR","Tooth scheduled for extraction will be removed in the least traumatic way. The socket will be filled with the comparator (Bio-Oss® Geistlich, granules 0.25 - 1mm). Two follow up visits to monitor the healing process will take place at 2 and 6 weeks after surgery. Implant placement will be performed 4 months after the regenerative procedure. Implant loading will be allowed after having waited a minimum of 3 months after the implant placement and after a control visit. The implant survival and success will be assessed at 3, 6 and 12 months after implant placement. A long-term follow-up will evaluate the implant survival and success at 3 and 5 years post implant placement.",[13],"Device: Tooth extraction and bone graft procedure",{"label":15,"type":16,"description":17,"interventionNames":18},"WHA","EXPERIMENTAL","Tooth scheduled for extraction will be removed in the least traumatic way. The socket will be filled with the investigational device (WHA, granules 0.25- 1.0mm). Two follow up visits to monitor the healing process will take place at 2 and 6 weeks after surgery. Implant placement will be performed 4 months after the regenerative procedure. Implant loading will be allowed after having waited a minimum of 3 months after the implant placement and after a control visit. The implant survival and success will be assessed at 3, 6 and 12 months after implant placement. A long-term follow-up will evaluate the implant survival and success at 3 and 5 years post implant placement.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Tooth extraction and bone graft procedure","The subject will receive a flash dose of 2 gr of amoxicillin or 600 mg of Clindamycin 1 hour before the surgery.\n\nTooth will be extracted using gentle techniques to guarantee an atraumatic extraction. If the socket presents insufficient bleeding, the clinician must use an appropriate procedure to induce bleeding. The extraction site must be carefully cleaned. Extraction socket will then be filled with WHA or Bio-Oss previously hydrated with saline solution (0.9%). Extraction socket packed with the graft will be covered with a collagen sponge (Geistlich Mucograft® Seal) and sutured (cross suture, Vicryl rapide 4.0).\n\nIf required, a limited connective tissue graft can be placed in the vestibular region.\n\nA CBCT scan will be performed after the bone graft procedure, i.e., after the extraction socket and the biomaterial placement, to measure the initial bone width.\n\nThe safety of the investigational device will be evaluated.",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Bruno De Carvalho","Clinician","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Emilie Dory, CEO","CONTACT","+32484706172","emilie.dory@wishbone-biotech.com",{"name":38,"role":34,"phone":39,"phoneExt":25,"email":40},"Justine Pirson, R&D Manager","+3249487202","justine.pirson@wishbone-biotech.com",[42,63,77,90,105],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Clinique de la Source DentalMe","RECRUITING","Louvain-la-Neuve","Brabant Wallon","1348","Belgium","BE",{"type":51,"coordinates":52},"Point",[53,54],4.61443,50.66829,{"lat":54,"lon":53},[57,60],{"name":58,"role":34,"phone":25,"phoneExt":25,"email":59},"Sami El Masri","dentiste.elmasri@gmail.com",{"name":61,"role":62,"phone":25,"phoneExt":25,"email":25},"Laurane Pansaers","SUB_INVESTIGATOR",{"facility":64,"status":44,"city":65,"state":66,"zip":67,"country":48,"countryCode":49,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Cabinet Debaty-Techy","Aubel","Liège","4880",{"type":51,"coordinates":69},[70,71],5.85812,50.70189,{"lat":71,"lon":70},[74],{"name":75,"role":34,"phone":25,"phoneExt":25,"email":76},"Bertrand Debaty","bertranddebaty@gmail.com",{"facility":78,"status":44,"city":79,"state":66,"zip":80,"country":48,"countryCode":49,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Clinique du Faubourg DentalMe","Chaudfontaine","4053",{"type":51,"coordinates":82},[83,84],5.6341,50.5828,{"lat":84,"lon":83},[87],{"name":88,"role":34,"phone":25,"phoneExt":25,"email":89},"Souheil Salem","souhsal@yahoo.fr",{"facility":91,"status":44,"city":66,"state":25,"zip":92,"country":48,"countryCode":49,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Centre Hospitalier Université de Liège","4000",{"type":51,"coordinates":94},[95,96],5.56749,50.63373,{"lat":96,"lon":95},[99,101,103],{"name":28,"role":34,"phone":25,"phoneExt":25,"email":100},"mailto:bruno.decarvalho@chuliege.be",{"name":102,"role":62,"phone":25,"phoneExt":25,"email":25},"Lemmy Liegeois",{"name":104,"role":62,"phone":25,"phoneExt":25,"email":25},"Gilles Szotek",{"facility":106,"status":44,"city":107,"state":25,"zip":108,"country":48,"countryCode":49,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Centre Oxalys","Namur","5020",{"type":51,"coordinates":110},[111,112],4.86746,50.4669,{"lat":112,"lon":111},[115],{"name":116,"role":34,"phone":25,"phoneExt":25,"email":117},"Adrien Bolette","bolette.adrien@gmail.com",{"type":119,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[121,124,127],{"name":122,"class":123},"EVAMED","OTHER",{"name":125,"class":126},"Pharmalex","UNKNOWN",{"name":128,"class":126},"Advimago","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":141,"type":142},96,"ESTIMATED","INTERVENTIONAL",[145],"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.",[148,149],"Bone Regeneration","Safety Issues","2024-05-28",{"date":152,"type":153},"2024-05-29","ACTUAL",{"date":155,"type":153},"2024-04-26",{"date":157,"type":142},"2030-03-31",{"name":5,"class":6},5]