[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563945":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":42,"locations":51,"responsibleParty":73,"collaborators":29,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":29,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":29,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":54,"whyStopped":29,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Aristotle University Of Thessaloniki","OTHER",[8,13,19],{"label":9,"type":6,"description":10,"interventionNames":11},"No Graft","In the control group, the implant will be placed without any kind of soft tissue graft. Also, it will be placed at the level of the bone and the flaps will be sutured with 5\u002F0 absorbable sutures.",[12],"Procedure: Control group",{"label":14,"type":15,"description":16,"interventionNames":17},"CTG","EXPERIMENTAL","In the first experimental group, prosthetically guided implant placement will be performed as well as an increase of the soft tissue volume with an autologous Connective Tissue Graft (CTG). The implant will be placed up to the level of the bone. The autologous graft will be harvested either from the palate as a free gingival graft or as a subepithelial graft, or from the maxillary cusps. The graft will be immobilized in the buccal flap with two simple interrupted sutures and 5\u002F0 absorbable sutures covering the buccal and coronal surfaces of the alveoral bone. Finally, the flap will be displaced coronally so that we have closure in the first place.",[18],"Procedure: CTG",{"label":20,"type":15,"description":21,"interventionNames":22},"Collagen Matrix","In the second experimental group, prosthetically guided implant placement and simultaneous soft tissue volume augmentation with porcine Collagen Matrix (CM) - Geistlich FibroGide - will be performed. Initially, full-thickness flap will be raised mainly buccally but also palatally. The implant will then be placed at the level of the bone. The flap will buccally become partial thickness and full thickness again so that we can move it coronally to cover and perfuse the graft. The collagenous graft will be shaped to fit the surgical site, be covered by the periosteum, and will completely cover the buccal bone. Also, it should expand coronal to the alveoral crest. Two horizontal matress sutures (P.G.A 5\u002F0 absorbable) will immobilize the graft. Finally, the buccal flap will be displaced coronally, so that we have convergence in the first place.",[23],"Procedure: Collagen Matrix",[25,30,33],{"type":26,"name":14,"description":27,"armGroupLabels":28,"otherNames":29},"PROCEDURE","Connective Tissue Graft has been widely used around implants to increase either the thickness of the soft tissues or the width of keratinized tissues. It is considered the gold standard for soft tissue grafting. The main drawbacks are the donor morbidity and the limit amount of intraoral donor sites. In this study it will be used in the test 1 group in order to compare its clinical results with the other groups.",[14],null,{"type":26,"name":20,"description":31,"armGroupLabels":32,"otherNames":29},"Collagen matrix has been used in several studies in order to evaluate its clinical properties over the last years. In this study, the graft will be placed buccally at the time of implant placement in the aesthetic zone in order to assess its clinical and radiographic properties in terms of buccal bone resorption and soft tissue augmentation. Histological assessment and Patient Reported outcomes will also be evaluated.",[20],{"type":26,"name":34,"description":35,"armGroupLabels":36,"otherNames":29},"Control group","In the control group, the implant will be placed without any kind of soft tissue graft in order to compare this treatment modality that many clinicians apply at the clinical practice.",[9],[38],{"name":39,"affiliation":40,"role":41},"Ioannis Vouros, DDS, Ph.D","Aristotle Univerity of Thessaloniki","STUDY_CHAIR",[43,47],{"name":39,"role":44,"phone":45,"phoneExt":29,"email":46},"CONTACT","+302310999597","iovouros@dent.auth.gr",{"name":48,"role":44,"phone":49,"phoneExt":29,"email":50},"Louiza Papantonatou, DDS","+306984301130","lpapantonatou@gmail.com",[52],{"facility":53,"status":54,"city":55,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Department of Preventive Dentistry, Periodontology & Implant Biology, School of Dentistry, Aristotle University","RECRUITING","Thessaloniki","54124","Greece","GR",{"type":60,"coordinates":61},"Point",[62,63],22.93493,40.64072,{"lat":63,"lon":62},[66,68,69,71],{"name":39,"role":44,"phone":67,"phoneExt":29,"email":46},"+306932907030",{"name":48,"role":44,"phone":49,"phoneExt":29,"email":50},{"name":39,"role":70,"phone":29,"phoneExt":29,"email":29},"PRINCIPAL_INVESTIGATOR",{"name":48,"role":72,"phone":29,"phoneExt":29,"email":29},"SUB_INVESTIGATOR",{"type":70,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Ioannis Vouros","Study Chair: Ioannis Vouros, DDS, PhD, Professor of Periodontology","100563945","phase-2-the-use-of-a-porcine-collagen-matrix-for-the-prevention-of-buccal-bone-wall-resorption-during-implant-placement-in-the-aesthetic-zone-100563945",false,"NCT06622759","The Use of a Porcine Collagen Matrix for the Prevention of Buccal Bone Wall Resorption During Implant Placement in the Aesthetic Zone.","The Use of a Porcine Collagen Matrix for the Prevention of Buccal Bone Wall During Implant Placement in the Aesthetic Zone. A Randomized Controlled Clinical Trial.","Inclusion Criteria:\n\n1. Generally healthy adult patients.\n2. 18 years or older.\n3. Need for replacement of single implant in the upper aesthetic zone (second premolar to second premolar)\n4. Ridge width (bucco-lingual) no greater than 6 mm at its narrowest point.\n5. Minimum 2mm of attached gingiva.\n6. Ability to comply with the study related procedures such as exercising good oral hygiene and attending all follow-up examinations.\n7. Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form\n\nExclusion Criteria:\n\n1. Poor oral hygiene (FMPS \\\u003C 20%, FMBS \\\u003C 15%) and poor motivation\n2. Heavy smokers (\\>10 cigarettes per day)\n3. Need for bone augmentation\n4. Untreated periodontitis\n5. General contraindications for dental and\u002For surgical treatment\n6. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years\n7. Women of child bearing age, not using a standard accepted method for contraception\n8. Pregnancy or breast feeding\n9. Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs\n10. Disease affecting connective tissue metabolism (e.g. collagenases)\n11. Allergy to collagen",true,"ALL","18 Years","75 Years",{"count":88,"type":89},36,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","Aim:\n\nTo provide a comparative assessment of the clinical and radiographic effect of porcine collagen matrix when placed buccally at the time of single implant placement in the aesthetic zone vs autogenous connective tissue graft in terms of buccal bone resorption and soft tissue augmentation 6 months post operative. Histological assessment and patient reported outcomes were reported",[95],"Soft Tissue Augmentation",[97,98,99,100,101,102,103],"Implants","Esthetic zone","Soft tissue augmentation","Collagen matrix","Soft tissue grafts","Connetive Tissue Graft","Porcine collagen matrix","2025-08-03",{"date":106,"type":107},"2025-08-07","ACTUAL",{"date":109,"type":107},"2023-03-24",{"date":111,"type":89},"2025-08-30",{"name":5,"class":6},1]