[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536859":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":67,"collaborators":69,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":26,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":26,"enrollmentInfo":93,"targetDuration":26,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Göteborg University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Access flap + bone substitute","EXPERIMENTAL","Furcation defect will be treated by access flap debridement followed by application of a bone substitute material.",[13,14],"Procedure: Access flap & surgical debridement","Procedure: Application of bone substitute material (BioOss Collagen)",{"label":16,"type":17,"description":18,"interventionNames":19},"Access flap","ACTIVE_COMPARATOR","Furcation defect will be treated by access flap debridement alone.",[13],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Access flap & surgical debridement","Following surgical exposure, roots are carefully debrided.",[16,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Application of bone substitute material (BioOss Collagen)","Following surgical debridement, the bone substitute material is applied to the furcation defect.",[9],[32],{"name":33,"affiliation":5,"role":34},"Karolina Karlsson, PhD","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Jan Derks, PhD","CONTACT","+46766183124‬","jan.derks@odontologi.gu.se",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Kostas Bougas, PhD","+46766181208","kostas.bougas@gu.se",[46],{"facility":47,"status":48,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Department of Periodontology, Institute of Odontology","RECRUITING","Gothenburg","40530","Sweden","SE",{"type":54,"coordinates":55},"Point",[56,57],11.96679,57.70716,{"lat":57,"lon":56},[60,62,64,66],{"name":37,"role":38,"phone":61,"phoneExt":26,"email":40},"0046 76 618 3124",{"name":37,"role":63,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":33,"role":65,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"name":42,"role":65,"phone":26,"phoneExt":26,"email":26},{"type":68,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[70,72,74,76,78,81],{"name":71,"class":6},"Johann Wolfgang Goethe University Hospital",{"name":73,"class":6},"Charite University, Berlin, Germany",{"name":75,"class":6},"King's College London",{"name":77,"class":6},"Queen Mary University of London",{"name":79,"class":80},"Geistlich Pharma AG","INDUSTRY",{"name":82,"class":83},"Vastra Gotaland Region","OTHER_GOV","100536859","use-of-a-bone-substitute-material-in-the-surgical-therapy-of-furcation-defects-100536859",false,"NCT06270303","Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects","The Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects - a Multi-center Randomized Controlled Trial","Inclusion Criteria:\n\nPatients should present with at least one surgically accessible molar (in tooth position 6 or 7) diagnosed with a single furcation defect degree II (at any aspect).\n\nFollowing initial periodontal therapy, teeth to be included should present with one site with furcation defect degree II in combination with:\n\n* Bleeding on probing\n* Probing pocket depth of ≥6 mm\n* Soft tissue coverage of the furcation entrance Patients should present with a full mouth plaque score ≤25%.\n\nExclusion Criteria:\n\n* Multiple deep furcation defects (degree II - III) at the same tooth\n* Vertical attachment loss \\>50% at aspects not facing the furcation defect\n* Defects presenting with apico-marginal communication\n* Intake of systemic antibiotics within 6 months\n* Systemic conditions\u002Fmedication impeding surgical intervention (e.g. uncontrolled diabetes, immunosuppressive medication)","ALL","18 Years",{"count":94,"type":95},200,"ESTIMATED","INTERVENTIONAL",[98],"NA","The aim of this randomized clinical trial is to evaluate the potential benefit of the use of a bone substitute material in the treatment of furcation degree II-involved molars. The main question it aims to answer is: What is the benefit of the adjunctive use of a bone substitute material in the surgical treatment of furcation degree II-involved molars when compared to open-flap debridement alone?\n\n200 patients with ≥1 molar presenting with a furcation defect degree II will be included and randomized to either control (open-flap debridement) or test treatment (open-flap debridement + bone substitute material). The primary outcome of the study is furcation closure defined as absence of clinically detectable furcation involvement degree \\>I. Secondary outcomes include changes in bleeding on probing, probing depth, vertical and horizontal attachment levels, soft tissue level, marginal bone level, need for surgical retreatment, tooth loss, patient-reported outcomes and adverse events. A composite outcome based on furcation closure (degree ≤I) in combination with shallow probing depth (≤5 mm) and absence of bleeding on probing will also be evaluated.",[101,102],"Periodontitis","Furcation Defects",[104,105,106],"Surgical therapy","Reconstructive","Randomized controlled trial","2025-08-20",{"date":109,"type":110},"2025-08-21","ACTUAL",{"date":112,"type":110},"2025-03-27",{"date":114,"type":95},"2037-03-01",{"name":5,"class":6},1]