[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555818":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":46,"locations":52,"responsibleParty":70,"collaborators":29,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":29,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":29,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":29,"overallStatus":55,"whyStopped":29,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Università Vita-Salute San Raffaele","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Test group (DBBM+HA)","EXPERIMENTAL","In Test group, the gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral with hyaluronic acid (Botiss Cerabone Plus; Botiss biomaterials, Hauptstr. 28 15806 Zossen, Germany). The material will be pre-wetted in saline, inserted in the gap and once soaked in blood, it will be gently pressed to the bone walls to completely fill the space and around buccal aspects of the exposed implant surface, up to the top of the abutment.",[13,14,15,16],"Procedure: Tooth Extraction","Procedure: Immediate Implant Placement","Procedure: Socket reconstruction with DBBB+HA","Procedure: CTG placement",{"label":18,"type":19,"description":20,"interventionNames":21},"Control group (DBBM)","ACTIVE_COMPARATOR","In Control group, deproteinized bovine bone mineral (DBBM) (Bio-Oss Collagen; Geistlich Pharma, Wolhusen, Switzerland) will be positioned in the gap. The material will be pre-wetted in saline, inserted in the gap and once soaked in blood, it will be gently pressed to the bone walls to completely fill the space and around buccal aspects of the exposed implant surface, up to the top of the abutment.",[13,14,22,16],"Procedure: Socket reconstruction with DBBB",[24,30,34,38,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"PROCEDURE","Tooth Extraction","After local anaesthesia, a buccal split-full-split-thickness envelope flap will be elevated, and the tooth will be extracted a-traumatically.",[18,9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Immediate Implant Placement","After providing that the extraction socket will meet the inclusion criteria, an implant will be immediately inserted with 1 mm of its transmucosal portion positioned under the interproximal bone crest.",[18,9],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Socket reconstruction with DBBB+HA","The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral with hyaluronic acid (DBBM+HA).",[9],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Socket reconstruction with DBBB","The gap between the implant surface and the bone plates will be filled with deproteinized bovine bone mineral (DBBM).",[18],{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"CTG placement","Once the appropriate healing abutments will be installed, a CTG will be utilized as a barrier membrane. Then, the buccal flap will be coronally advanced and will be adapted to the healing abutment.",[18,9],[47],{"name":48,"role":49,"phone":50,"phoneExt":29,"email":51},"Giovanna Laura Di Domenico","CONTACT","+393485826742","giovannalauradd@gmail.com",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":29,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Ospedale San Raffaele","RECRUITING","Milan","Mi","Italy","IT",{"type":61,"coordinates":62},"Point",[63,64],9.18951,45.46427,{"lat":64,"lon":63},[67],{"name":68,"role":49,"phone":69,"phoneExt":29,"email":51},"Giovanna Laura Di Domenico, DDS","0226432806",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Massimo de Sanctis","Professor","100555818","socket-reconstruction-technique-and-immediate-implant-placement-with-two-different-bone-substitute-materials-100555818",false,"NCT06517030","Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials.","Clinical and Radiographic Evaluation of a Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials: a Multicentric Randomized Clinical Trial.","Inclusion Criteria:\n\n1. Participant is willing and able to give informed consent for participation in the trial.\n2. In good general health as evidenced by medical history.\n3. Presenting a single hopeless tooth candidate for extraction in the maxillary or mandibular area (from second premolar to second premolar, intercalated or the last tooth of dental arch) in need of a single implant-supported fixed prosthetic rehabilitation.\n4. Presence of \\>3mm of buccal wall dehiscence evaluated using Cone Beam Computed Tomography (CBCT).\n5. In healthy periodontal conditions (i.e., no presence of sites ≥ 4 mm and\u002For presence of intra-bony defects in the selected sites, full mouth plaque score \\\u003C 20% and full-mouth bleeding score \\\u003C 20%).\n\nExclusion Criteria:\n\n1. Current or previous use of immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.\n2. Presence of inflammatory and autoimmune disease of the oral cavity.\n3. Severe or poorly controlled diabetes or previous radiotherapy of head area.\n4. Contraindications to dental and\u002For surgical interventions (e.g. severe endocrine bone diseases, severe metabolic bone disorders, malignant tumour diseases).\n5. Individuals who are smokers of \\>10 cigarettes\u002Fday.\n6. Female participant who is pregnant, lactating or planning pregnancy during the course of the study.\n7. Presence of \\\u003C3mm of dehiscence of buccal walls of the socket after tooth extraction.\n8. Presence of a distance between the interdental bone crest and buccal bone crest \\\u003C3 mm after tooth extraction.",true,"ALL","22 Years","70 Years",{"count":86,"type":87},30,"ESTIMATED","INTERVENTIONAL",[90],"NA","The present research is a national multicentric prospective parallel double-blinded (both the patient and the examiner are blind) randomized controlled clinical trial. It is a superiority comparative study on a medical device CE (conformité européenne) marking, used according to the intended use subject to the CE marking.\n\nThe hypothesis tested is: the socket reconstruction procedure performed in conjunction with Immediate implant placement (IIP) with the use of Deproteinized bovine bone mineral + hyaluronic acid (DBBM+HA, Cerabone plus) leads to a greater increase in the vertical buccal bone height than same procedure with deproteinized bovine bone mineral alone (DBBM, Bio-oss Collagen).",[93],"Dental Implant","2025-04-12",{"date":96,"type":97},"2025-04-16","ACTUAL",{"date":99,"type":87},"2025-04",{"date":101,"type":87},"2025-09",{"name":5,"class":6},1]