protocolSection identificationModule nctId: NCT06383377, orgStudyIdInfo 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2030-03-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Wishbone SA, class: INDUSTRY, collaborators name: EVAMED, collaborators name: Pharmalex, collaborators name: Advimago, descriptionModule 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., conditionsModule conditions: Bone Regeneration, conditions: Safety Issues, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo 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, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Tooth extraction and bone graft procedure, outcomesModule primaryOutcomes measure: Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure., secondaryOutcomes measure: Assessment of the bone density at implant placement., secondaryOutcomes measure: Evaluation of the implant primary stability., secondaryOutcomes measure: Assessment of the implant osteointegration after implant placement, secondaryOutcomes 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, secondaryOutcomes measure: Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness, secondaryOutcomes measure: Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire., secondaryOutcomes measure: Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement., secondaryOutcomes measure: Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique de la Source DentalMe, status: RECRUITING, city: Louvain-la-Neuve, state: Brabant Wallon, zip: 1348, country: Belgium, contacts name: Sami El Masri, role: CONTACT, email: dentiste.elmasri@gmail.com, contacts name: Laurane Pansaers, role: SUB_INVESTIGATOR, geoPoint lat: 50.66829, lon: 4.61443, locations facility: Cabinet Debaty-Techy, status: RECRUITING, city: Aubel, state: Liège, zip: 4880, country: Belgium, contacts name: Bertrand Debaty, role: CONTACT, email: bertranddebaty@gmail.com, geoPoint lat: 50.70189, lon: 5.85812, locations facility: Clinique du Faubourg DentalMe, status: RECRUITING, city: Chaudfontaine, state: Liège, zip: 4053, country: Belgium, contacts name: Souheil Salem, role: CONTACT, email: souhsal@yahoo.fr, geoPoint lat: 50.5828, lon: 5.6341, locations facility: Centre Hospitalier Université de Liège, status: RECRUITING, city: Liège, zip: 4000, country: Belgium, contacts name: Bruno De Carvalho, role: CONTACT, email: mailto:bruno.decarvalho@chuliege.be, contacts name: Lemmy Liegeois, role: SUB_INVESTIGATOR, contacts name: Gilles Szotek, role: SUB_INVESTIGATOR, geoPoint lat: 50.63373, lon: 5.56749, locations facility: Centre Oxalys, status: RECRUITING, city: Namur, zip: 5020, country: Belgium, contacts name: Adrien Bolette, role: CONTACT, email: bolette.adrien@gmail.com, geoPoint lat: 50.4669, lon: 4.86746, hasResults: False