nctId: NCT06383377 id: Pre-market parallel study briefTitle: Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation overallStatus: RECRUITING date: 2024-04-26 date: 2025-03-31 date: 2030-03-31 date: 2024-04-25 date: 2024-04-25 name: Wishbone SA class: INDUSTRY name: EVAMED name: Pharmalex name: Advimago briefSummary: 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. conditions: Bone Regeneration conditions: Safety Issues studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The parallel group will be treated with the product Bio-Oss® in a 1:1 randomization. Bio- Oss® is a natural bone mineral of bovine origin. Bio-Oss® is available as granules of spongious bone. Sterilization of Bio-Oss® is carried out by irradiation. Bio-Oss® has a macro- and microporous structure similar to human spongious bone. Bio-Oss® supports the in-growth of new bone at the implantation site by serving as a stable scaffold for osteoblasts; over time it is subject to the physiological remodeling process. Bio-Oss® is slowly resorbable, depending on the physiological environment of the individual patient, or integrated into the host bone. The highly purified osteoconductive mineral structure is produced from natural bone in a multistage purification process, adhering to the strictest safety regulations. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients will not be informed of their randomization assignment until the 1 year post implant placement follow-up visit. At this timepoint, the primary endpoint will have been achieved (at the implant placement visit) as well as the majority of the secondary endpoints. After the bone grafting surgery, all patients will receive an identic implant cart that does not break the blinding of the study. 1 year after implant placement, the patients will receive their definitive implant cart. whoMasked: PARTICIPANT count: 96 type: ESTIMATED name: Tooth extraction and bone graft procedure measure: Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure. measure: Assessment of the bone density at implant placement. measure: Evaluation of the implant primary stability. measure: Assessment of the implant osteointegration after implant placement measure: Implant survival rate and success evaluated at 3-, 6- and 12-months and 3- and 5- To evaluate implant survival and success 3-, 6- and 12- months and 3- and 5-years after implant placement measure: Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness measure: Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire. measure: Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement. measure: Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique de la Source DentalMe status: RECRUITING city: Louvain-la-Neuve state: Brabant Wallon zip: 1348 country: Belgium name: Sami El Masri role: CONTACT email: dentiste.elmasri@gmail.com name: Laurane Pansaers role: SUB_INVESTIGATOR lat: 50.66829 lon: 4.61443 facility: Cabinet Debaty-Techy status: RECRUITING city: Aubel state: Liège zip: 4880 country: Belgium name: Bertrand Debaty role: CONTACT email: bertranddebaty@gmail.com lat: 50.70189 lon: 5.85812 facility: Clinique du Faubourg DentalMe status: RECRUITING city: Chaudfontaine state: Liège zip: 4053 country: Belgium name: Souheil Salem role: CONTACT email: souhsal@yahoo.fr lat: 50.5828 lon: 5.6341 facility: Centre Hospitalier Université de Liège status: RECRUITING city: Liège zip: 4000 country: Belgium name: Bruno De Carvalho role: CONTACT email: mailto:bruno.decarvalho@chuliege.be name: Lemmy Liegeois role: SUB_INVESTIGATOR name: Gilles Szotek role: SUB_INVESTIGATOR lat: 50.63373 lon: 5.56749 facility: Centre Oxalys status: RECRUITING city: Namur zip: 5020 country: Belgium name: Adrien Bolette role: CONTACT email: bolette.adrien@gmail.com lat: 50.4669 lon: 4.86746 hasResults: False