[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658619":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":29,"studyPopulation":25,"armGroups":30,"interventions":44,"overallOfficials":59,"centralContacts":63,"locations":72,"responsibleParty":94,"collaborators":97,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":25,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":25,"enrollmentInfo":111,"targetDuration":25,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":123,"overallStatus":129,"whyStopped":25,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"University of Zagreb","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Alveolar Bone Volume at the Treated Site","Alveolar bone volume will be measured on CBCT scans obtained before extraction and 3 months after socket preservation. Change will be calculated as the 3-month volume minus the baseline volume and reported in cubic millimeters. Measurements will use the same anatomically defined region of interest at both time points after image registration. Negative values indicate loss of measured bone volume.","Baseline before tooth extraction and 3 months after alveolar socket preservation",[14],{"measure":15,"description":16,"timeFrame":17},"Percentage of Newly Formed Bone","Newly formed bone will be quantified by histomorphometric examination of a bone biopsy obtained from the treated site at implant placement. The outcome will be the area of newly formed bone divided by the total analyzed tissue area, multiplied by 100, and expressed as a percentage.","3 months after alveolar socket preservation, at implant placement",[19],{"measure":20,"description":21,"timeFrame":17},"Percentage of Residual Bone Graft Material","Residual graft material will be quantified in the bone biopsy obtained at implant placement. The outcome will be the area of residual graft particles divided by the total analyzed tissue area, multiplied by 100, and expressed as a percentage.",{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":26,"observationalModel":25,"timePerspective":25,"maskingInfo":27},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":28,"maskingDescription":25,"whoMasked":25},"NONE","Tooth extraction is followed by changes in alveolar bone and soft tissue dimensions that may affect subsequent implant treatment. This prospective, randomized, controlled clinical study will compare healing after alveolar socket preservation using an allogeneic bone graft covered by either a resorbable magnesium membrane (NOVAMag) or a non-resorbable polytetrafluoroethylene membrane (permamem).\n\nThe study will be conducted at the Department of Oral Surgery, School of Dental Medicine, University of Zagreb. Eligible participants will require tooth extraction in the maxilla or mandible followed by implant placement in the treated region. Eligible participants will have an American Society of Anesthesiologists physical status classification of I or II and will provide written informed consent.\n\nFollowing atraumatic extraction under local anesthesia, granulation tissue will be removed from the socket. The socket will be irrigated with sterile saline and filled with the same allogeneic bone graft in both groups. Participants will be randomly allocated to either the NOVAMag group or the permamem group. Membranes will be adapted to the socket dimensions and placed according to the applicable surgical protocol. Anesthesia, extraction technique, and suturing will be standardized between groups.\n\nClinical examinations will be performed at 7 days, 21 days, and 3 months after surgery to assess soft tissue healing and postoperative complications. CBCT imaging will be obtained before extraction and at 3 months, before implant placement, to assess changes in alveolar bone volume.\n\nAt implant placement, approximately 3 months after socket preservation, a bone sample will be collected from the treated site. Histological and histomorphometric assessments will evaluate newly formed bone and residual graft material. Clinical, radiographic, and histological findings will be compared between groups.\n\nThe protocol specifies a null hypothesis of no difference in bone and soft tissue healing between the membrane groups. The planned comparison is not an equivalence or non-inferiority trial, and no equivalence or non-inferiority margin is specified.",[31,38],{"label":32,"type":33,"description":34,"interventionNames":35},"Allogeneic Bone Graft With NOVAMag Membrane","EXPERIMENTAL","Following atraumatic tooth extraction, the socket will be debrided, irrigated with sterile saline, and filled with an allogeneic bone graft. The augmented socket will be covered with a resorbable magnesium membrane (NOVAMag). The remaining surgical procedures and follow-up schedule will be standardized between groups.",[36,37],"Device: NOVAMag Membrane","Procedure: Alveolar Socket Preservation With an Allogeneic Bone Graft",{"label":39,"type":40,"description":41,"interventionNames":42},"Allogeneic Bone Graft With permamem Membrane","ACTIVE_COMPARATOR","Following atraumatic tooth extraction, the socket will be debrided, irrigated with sterile saline, and filled with the same allogeneic bone graft used in the experimental group. The augmented socket will be covered with a non-resorbable polytetrafluoroethylene membrane (permamem). The remaining surgical procedures and follow-up schedule will be standardized between groups.",[43,37],"Device: permamem Membrane",[45,50,54],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":25},"DEVICE","NOVAMag Membrane","Placement of a resorbable magnesium barrier membrane over the grafted extraction socket during alveolar socket preservation.",[32],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":25},"permamem Membrane","Placement of a non-resorbable polytetrafluoroethylene barrier membrane over the grafted extraction socket during alveolar socket preservation.",[39],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":25},"PROCEDURE","Alveolar Socket Preservation With an Allogeneic Bone Graft","Atraumatic tooth extraction, socket debridement, and saline irrigation, followed by placement of an allogeneic bone graft. The grafted socket will be covered with the membrane assigned to the participant's treatment group.",[32,39],[60],{"name":61,"affiliation":5,"role":62},"Igor Smojver, DMD;PhD","STUDY_DIRECTOR",[64,69],{"name":65,"role":66,"phone":67,"phoneExt":25,"email":68},"Zvonimir Živković, DMD","CONTACT","+38514802119","zvonimirzivkovic94@gmail.com",{"name":70,"role":66,"phone":25,"phoneExt":25,"email":71},"Marko Vuletić, DMD;PhD","mvuletic@sfzg.hr",[73],{"facility":74,"status":25,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"School of Dental Medicine","Zagreb","City of Zagreb","10000","Croatia","HR",{"type":81,"coordinates":82},"Point",[83,84],15.97798,45.81444,{"lat":84,"lon":83},[87,89,92],{"name":88,"role":66,"phone":67,"phoneExt":25,"email":71},"Marko Vuletić, PhD",{"name":90,"role":66,"phone":25,"phoneExt":25,"email":91},"Igor Smojver, PhD","ismojver@sfzg.hr",{"name":65,"role":93,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":93,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Igor Smojver","Senior Research Asisstant, DMD;PhD",[98],{"name":99,"class":100},"Botiss Biomaterials GmbH","INDUSTRY","100658619","bone-and-soft-tissue-healing-after-socket-preservation-with-novamag-or-permamem-membranes-100658619",false,"NCT07856693","Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes","Comparative Evaluation of Bone and Soft Tissue Healing Following Alveolar Socket Preservation Using Maxgraft Plus With NOVAMag and Permamem Membranes","Inclusion Criteria:\n\n* Adults meeting the study's confirmed minimum age criterion.\n* A tooth in the maxilla or mandible indicated for extraction.\n* Planned dental implant placement in the treated region.\n* American Society of Anesthesiologists physical status I or II.\n* Written informed consent.\n\nEligible extraction indications include periapical inflammatory lesions, retained roots, advanced periodontal destruction, tooth fractures, and teeth that cannot be restored or treated endodontically.\n\nExclusion Criteria:\n\n* Uncontrolled chronic disease that may interfere with bone or soft tissue healing, including uncontrolled diabetes mellitus.\n* Immune disorders or osteoporosis that may interfere with bone or soft tissue healing.\n* Use of medications that affect bone metabolism.\n* American Society of Anesthesiologists physical status III or higher.",true,"ALL","25 Years",{"count":112,"type":113},50,"ESTIMATED","INTERVENTIONAL",[116],"NA","After tooth extraction, the surrounding bone and soft tissue may undergo dimensional reduction. Socket preservation involves placement of a bone graft into the extraction socket and coverage with a membrane to support healing before dental implant placement.\n\nThis study will compare two membranes used with the same allogeneic bone graft. One group will receive a resorbable magnesium membrane (NOVAMag), and the other group will receive a non-resorbable polytetrafluoroethylene membrane (permamem). Participants requiring tooth extraction followed by implant placement will be randomly assigned to one of the two groups.\n\nExtraction and grafting procedures will be standardized. Follow-up examinations will take place 7 days, 21 days, and 3 months after socket preservation. Soft tissue healing and postoperative complications will be assessed. Cone-beam computed tomography (CBCT) scans obtained before extraction and at 3 months will be used to evaluate changes in alveolar bone volume. During planned implant placement at 3 months, a bone sample will be collected from the treated site for microscopic examination.\n\nThe study aims to compare bone and soft tissue healing between the two membrane groups.",[119,120,121,122],"Alveolar Bone Loss","Tooth Loss \u002F Rehabilitation","Alveolar Bone Grafting","Socket Preservation",[124,125,126,127,128],"alveolar socket preservation","NOVAMag","permamem","Allogeneic bone graft","Histomorphometry","NOT_YET_RECRUITING","2026-10-02",{"date":132,"type":133},"2026-10-07","ACTUAL",{"date":135,"type":113},"2026-11-01",{"date":137,"type":113},"2028-07-31",{"name":5,"class":6},1]