protocolSection identificationModule nctId: NCT06270303, orgStudyIdInfo id: 2023-00383-01, briefTitle: Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2036-03-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Göteborg University, class: OTHER, collaborators name: Johann Wolfgang Goethe University Hospital, collaborators name: Charite University, Berlin, Germany, collaborators name: King's College London, collaborators name: Queen Mary University of London, collaborators name: Geistlich Pharma AG, collaborators name: Vastra Gotaland Region, descriptionModule briefSummary: 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?200 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., conditionsModule conditions: Periodontitis, conditions: Furcation Defects, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The project will be conducted as a two-armed randomized controlled trial in multiple clinical centers. The primary outcome will be assessed at 1 year post-surgery with a subsequent follow-up of 10 years., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Clinical assessments following intervention will be conducted by assessors unaware of group allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Access flap & surgical debridement, interventions name: Application of bone substitute material (BioOss Collagen), outcomesModule primaryOutcomes measure: Proportion of patients/teeth displaying furcation closure., primaryOutcomes measure: Proportion of patients/teeth displaying furcation closure., primaryOutcomes measure: Proportion of patients/teeth displaying furcation closure., primaryOutcomes measure: Proportion of patients/teeth displaying furcation closure., primaryOutcomes measure: Proportion of patients/teeth displaying furcation closure., primaryOutcomes measure: Proportion of patients/teeth displaying furcation closure., secondaryOutcomes measure: Changes in probing pocket depth., secondaryOutcomes measure: Changes in probing pocket depth., secondaryOutcomes measure: Changes in probing pocket depth., secondaryOutcomes measure: Changes in probing pocket depth., secondaryOutcomes measure: Changes in probing pocket depth., secondaryOutcomes measure: Changes in probing pocket depth., secondaryOutcomes measure: Changes in bleeding on probing., secondaryOutcomes measure: Changes in bleeding on probing., secondaryOutcomes measure: Changes in bleeding on probing., secondaryOutcomes measure: Changes in bleeding on probing., secondaryOutcomes measure: Changes in bleeding on probing., secondaryOutcomes measure: Changes in bleeding on probing., secondaryOutcomes measure: Changes in vertical and horizontal clinical attachment level., secondaryOutcomes measure: Changes in vertical and horizontal clinical attachment level., secondaryOutcomes measure: Changes in vertical and horizontal clinical attachment level., secondaryOutcomes measure: Changes in vertical and horizontal clinical attachment level., secondaryOutcomes measure: Changes in vertical and horizontal clinical attachment level., secondaryOutcomes measure: Changes in vertical and horizontal clinical attachment level., secondaryOutcomes measure: Changes in marginal soft tissue levels., secondaryOutcomes measure: Changes in marginal soft tissue levels., secondaryOutcomes measure: Changes in marginal soft tissue levels., secondaryOutcomes measure: Changes in marginal soft tissue levels., secondaryOutcomes measure: Changes in marginal soft tissue levels., secondaryOutcomes measure: Changes in marginal soft tissue levels., secondaryOutcomes measure: Changes in radiographic bone levels., secondaryOutcomes measure: Changes in radiographic bone levels., secondaryOutcomes measure: Changes in radiographic bone levels., secondaryOutcomes measure: Changes in radiographic bone levels., secondaryOutcomes measure: Patient satisfaction assessed by visual analogue scale., secondaryOutcomes measure: Patient satisfaction assessed by visual analogue scale., secondaryOutcomes measure: Patient discomfort as expressed on a visual analogue scale., secondaryOutcomes measure: Patient discomfort as expressed on a visual analogue scale., secondaryOutcomes measure: Esthetic appreciation as expressed on a visual analogue scale., secondaryOutcomes measure: Esthetic appreciation as expressed on a visual analogue scale., secondaryOutcomes measure: Rate of adverse events., secondaryOutcomes measure: Rate of adverse events., secondaryOutcomes measure: Tooth loss., secondaryOutcomes measure: Tooth loss., secondaryOutcomes measure: Tooth loss., secondaryOutcomes measure: Tooth loss., secondaryOutcomes measure: Tooth loss., secondaryOutcomes measure: Need for retreatment., secondaryOutcomes measure: Need for retreatment., secondaryOutcomes measure: Need for retreatment., secondaryOutcomes measure: Need for retreatment., secondaryOutcomes measure: Need for retreatment., secondaryOutcomes measure: Change of inflammatory markers., secondaryOutcomes measure: Change of inflammatory markers., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Periodontology, Institute of Odontology, city: Göteborg, zip: 40530, country: Sweden, contacts name: Jan Derks, PhD, role: CONTACT, phone: 0046 76 618 3124, email: jan.derks@odontologi.gu.se, contacts name: Jan Derks, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Karolina Karlsson, PhD, role: SUB_INVESTIGATOR, contacts name: Kostas Bougas, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False