[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100419429":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":37,"locations":46,"responsibleParty":77,"collaborators":27,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":27,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":27,"enrollmentInfo":89,"targetDuration":27,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":49,"whyStopped":27,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University Ghent","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","ACTIVE_COMPARATOR","Delayed implant placement",[13,14,15],"Device: Implant placement (BLX implant system, Straumann, Basel, Switzerland)","Procedure: Ridge preservation (Bio-Oss Collagen 250 mg, Geistlich Pharma AG, Wolhusen, Switserland)","Procedure: Socket seal (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switserland)",{"label":17,"type":18,"description":19,"interventionNames":20},"Test group","EXPERIMENTAL","Immediate implant placement",[13,14],[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","Implant placement (BLX implant system, Straumann, Basel, Switzerland)","Implants are placed after a healing period of 4 months (delayed implant placement, control group) or immediately after tooth extraction and ridge preservation (immediate implant placement, test group).",[9,17],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"PROCEDURE","Ridge preservation (Bio-Oss Collagen 250 mg, Geistlich Pharma AG, Wolhusen, Switserland)","Ridge preservation is performed by inserting a collagen-enriched DBBM (Bio-Oss Collagen 250 mg, Geistlich Pharma AG, Wolhusen, Switserland) in the empty extraction socket (delayed implant placement, control group) or by filling the gap between the implant and buccal bone wall (immediate implant placement, test group).",[9,17],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"Socket seal (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switserland)","The occlusal aspect of the grafted socket in the delayed implant placement\u002Fcontrol group is closed with a collagen matrix.",[9],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},"Jan Cosyn, Professor","CONTACT","+3293324000","jan.cosyn@ugent.be",{"name":44,"role":40,"phone":27,"phoneExt":27,"email":45},"Lorenz Seyssens, Phd candidate","lorenz.seyssens@ugent.be",[47,64],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Ghent University","RECRUITING","Ghent","Oost-Vlaanderen","9000","Belgium","BE",{"type":56,"coordinates":57},"Point",[58,59],3.71667,51.05,{"lat":59,"lon":58},[62,63],{"name":39,"role":40,"phone":27,"phoneExt":27,"email":42},{"name":44,"role":40,"phone":27,"phoneExt":27,"email":45},{"facility":65,"status":49,"city":66,"state":27,"zip":27,"country":53,"countryCode":54,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"UCL St Luc","Liège",{"type":56,"coordinates":68},[69,70],5.56749,50.63373,{"lat":70,"lon":69},[73,75],{"name":74,"role":40,"phone":27,"phoneExt":27,"email":27},"Selena Toma",{"name":74,"role":76,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"type":78,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100419429","immediate-versus-late-placement-100419429",false,"NCT04741607","Immediate Versus Late Placement","Alveolar Ridge Preservation With Immediate or Late Implant Placement: a Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* at least 18 years old\n* good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al. 1972)\n* presence of a single-rooted tooth in the anterior maxilla (15-25) that needs to be extracted for any reason with at least one neighboring tooth present\n* at least 3 mm bone available at the apical or palatal aspect of the alveolus to ensure primary implant stability\n* intact or nearly intact buccal bone wall at the time of extraction (max 3 mm bone missing = max 6 mm distance from free gingival margin to buccal bone crest)\n\nExclusion Criteria:\n\n* systemic diseases\n* smoking\n* untreated periodontal disease\n* untreated caries lesions",true,"ALL","18 Years",{"count":90,"type":91},60,"ESTIMATED","INTERVENTIONAL",[94],"NA","Patients in need of a single implant in the premaxilla will be invited to participate in this multicenter randomized controlled trial (RCT). Prior to surgery, a small-field low-dose cone beam computed tomography (CBCT) is taken to verify the integrity of the facial bone wall and an adequate amount of apical and palatal bone dimensions. Sixty patients will be randomly allocated to the test group or control group in 6 centers. Each center receives 10 sealed envelopes (5 are internally labelled with 'delayed implant placement' and 5 with 'immediate implant placement').\n\nFor each patient a digital planning is performed in implant planning software and a tooth-supported surgical guide is fabricated prior to tooth extraction.\n\nIn the control group, alveolar ridge preservation is performed following tooth extraction. After a healing period of 4 months, a single implant is installed.\n\nIn the test group, a single implant is installed immediately after tooth extraction and ridge preservation is performed by filling the gap between the facial bone wall and the implant surface.\n\nA provisional crown is placed at the day of implant surgery, which is replaced by a permanent one 3m later.\n\nSix months after tooth extraction and subsequent ridge preservation, the need for soft tissue grafting is assessed on the base of predetermined criteria (primary outcome measure). Soft tissue augmentation is performed by inserting a palatal connective tissue graft (CTG) into the buccal mucosa at the implant site.\n\nSecondary outcome measures include 3D hard and soft tissue changes as well as clinical, aesthetic, patient-reported and clinician-reported outcomes.",[97],"Esthetics",[99,100,101,102],"connective tissue graft","dental implant, single tooth","immediate","ridge preservation","2024-02-01",{"date":105,"type":106},"2024-02-02","ACTUAL",{"date":108,"type":106},"2021-01-01",{"date":110,"type":91},"2028-01-01",{"name":5,"class":6},2]