[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636726":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":21,"centralContacts":10,"locations":34,"responsibleParty":53,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":10,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":10,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Biruni University","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"Peri-implant health - smokers",null,"Individuals with at least one bone-level dental implant, who are current smokers, and are scheduled to undergo exposure surgery.",{"label":13,"type":10,"description":14,"interventionNames":10},"Peri-implant health - non-smokers","Individuals with at least one bone-level dental implant, who are non-smokers, and are scheduled to undergo exposure surgery.",{"label":16,"type":10,"description":17,"interventionNames":10},"Peri-implantitis - non-smokers","Individuals with peri-implantitis (non-smokers) were defined as subjects who were non-smokers and presented with bleeding and\u002For suppuration on gentle probing, an increased probing depth compared to previous examinations, and radiographic evidence of bone loss beyond crestal bone level changes resulting from initial bone remodelling. In cases where previous examination data were not available, peri-implantitis was diagnosed based on the presence of bleeding and\u002For suppuration on gentle probing, probing depths of ≥6 mm, and radiographic bone levels ≥3 mm apical to the most coronal portion of the intraosseous part of the implant.",{"label":19,"type":10,"description":20,"interventionNames":10},"Peri-implantitis - smokers","Individuals with peri-implantitis (smokers) were defined as subjects who were current smokers and presented with bleeding and\u002For suppuration on gentle probing, an increased probing depth compared to previous examinations, and radiographic evidence of bone loss beyond crestal bone level changes resulting from initial bone remodelling. In cases where previous examination data were not available, peri-implantitis was diagnosed based on the presence of bleeding and\u002For suppuration on gentle probing, probing depths of ≥6 mm, and radiographic bone levels ≥3 mm apical to the most coronal portion of the intraosseous part of the implant.",[22,25,28,31],{"name":23,"affiliation":5,"role":24},"Burcu Karaduman, PhD","STUDY_CHAIR",{"name":26,"affiliation":27,"role":24},"Ulvi K Gursoy, PhD","University of Turku",{"name":29,"affiliation":30,"role":24},"Mustafa Yilmaz, PhD","Istanbul University",{"name":32,"affiliation":5,"role":33},"Ayse Kaban","PRINCIPAL_INVESTIGATOR",[35],{"facility":5,"status":36,"city":37,"state":10,"zip":10,"country":38,"countryCode":10,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Istanbul","Turkey (Türkiye)",{"type":40,"coordinates":41},"Point",[42,43],28.94966,41.01384,{"lat":43,"lon":42},[46,51],{"name":47,"role":48,"phone":49,"phoneExt":10,"email":50},"Burcu Karaduman","CONTACT","+905323763366","bkaraduman@biruni.edu.tr",{"name":32,"role":52,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":33,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Burcu KARADUMAN","Prof. Dr.",[57,58],{"name":27,"class":6},{"name":59,"class":6},"The Scientific and Technological Research Council of Turkey","100636726","investigation-of-macrophage-polarization-in-peri-implant-health-and-peri-implantitis-100636726",false,"NCT07569432","Investigation of Macrophage Polarization in Peri-implant Health and Peri-implantitis","Inclusion Criteria:\n\n* Individuals who is suitable for the peri-implantitis diagnosis according to the classifications of periodontal and peri-implant diseases and conditions established in 2017.\n* Individuals with at least one bone-level dental implant and scheduled to undergo exposure surgery.\n\nExclusion Criteria:\n\n* prior peri-implantitis surgery\n* being diagnosed with autoimmune disease, genetic disorders, bone metabolism disorders, poorly controlled systemic diseases (such as diabetes or hypertension)\n* pregnancy or lactation\n* having a history of oral malignancy, chemotherapy or radiotherapy\n* use of anti-inflammatory drugs within 2 weeks, antibiotics within 3 months,\n* need for prophylactic antibiotics\n* contraindications for dental\u002Fsurgical procedures.","ALL","18 Years",{"count":69,"type":70},120,"ESTIMATED","OBSERVATIONAL","Peri-implantitis is a chronic inflammatory disease characterized by plaque-associated inflammation of the peri-implant mucosa and progressive loss of supporting bone around dental implants, which may ultimately lead to implant failure if left untreated.\n\nIt has been demonstrated that cellular and molecular responses of the host immune defense system play a critical role in the pathogenesis of peri-implantitis. Macrophages are key cells in the host immune response and are generally classified into two phenotypes: pro-inflammatory (M1) and anti-inflammatory (M2). While M1 macrophages are actively involved in the early defense response, a shift toward the M2 phenotype is required for the resolution of inflammation and tissue repair.\n\nSmoking has been shown to adversely affect macrophage polarization and function, thereby exacerbating inflammatory responses. Therefore, in the present study, levels of soluable CD163 (sCD163), B cell activating factor (BAFF), tumor necrosis factor-like weak inducer of apoptosis (TWEAK), a proliferation-inducing ligand (APRIL), interferon-gamma (IFN-γ), interleukin-10 (IL-10), interleukin-34 (IL-34), interleukin-35 (IL-35), and arginase activity (ornithine levels) will be evaluated in peri-implant health and peri-implantitis patients with varying disease severity and different smoking statuses. In addition, a comprehensive proteomic analysis will be performed to investigate the relationships among peri-implantitis severity, smoking, and macrophage polarization-related molecules. Baseline periodontal and peri-implant parameters will be recorded for all participants. In the peri-implant health group, tissue samples will be collected during exposure surgery performed for submerged implants, after which participants will be enrolled in supportive peri-implant care. Participants diagnosed with peri-implantitis will receive non-surgical therapy, during which tissue samples will be collected. Periodontal and peri-implant parameters will be reassessed for all participants at baseline, and at 6 and 12 weeks. Healthy peri-implant samples will be collected from submerged implants during exposure surgery. Peri-implantitis samples (probable pocket depth ≥ 6 mm with bleeding on probing) will be obtained during non-surgical therapy using a single stroke along the pocket wall.",[74],"Peri-implantitis",[76,77,78],"peri-implantitis","smoking","macrophage","2026-05-10",{"date":81,"type":82},"2026-05-13","ACTUAL",{"date":84,"type":70},"2026-04",{"date":86,"type":70},"2028-09",{"name":5,"class":6},1]