[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644529":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":44,"locations":53,"responsibleParty":68,"collaborators":71,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":34,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":34,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":98,"whyStopped":34,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Biruni University","OTHER",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"SS (Smokers + Synbiotic)","EXPERIMENTAL","Participants with generalized Stage III-IV Grade B\u002FC periodontitis who smoke and receive synbiotic supplementation once daily for 90 days in addition to non-surgical periodontal therapy.",[13],"Dietary Supplement: Synbiotic supplementation",{"label":15,"type":16,"description":17,"interventionNames":18},"SP (Smokers + Placebo)","PLACEBO_COMPARATOR","Participants with generalized Stage III-IV Grade B\u002FC periodontitis who smoke and receive placebo supplementation once daily for 90 days in addition to non-surgical periodontal therapy.",[19],"Other: Placebo Administration",{"label":21,"type":10,"description":22,"interventionNames":23},"NS (Non-smokers + Synbiotic)","Non-smoking participants with generalized Stage III-IV Grade B\u002FC periodontitis who receive synbiotic supplementation once daily for 90 days in addition to non-surgical periodontal therapy.",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"NP (Non-smokers + Placebo)","Non-smoking participants with generalized Stage III-IV Grade B\u002FC periodontitis who receive placebo supplementation once daily for 90 days in addition to non-surgical periodontal therapy.",[19],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DIETARY_SUPPLEMENT","Synbiotic supplementation","Product Name: Bigflor Capsule Food Supplement Containing Probiotic Microorganisms Approval Number: 005400-08.02.2019 Manufacturer: Nuvita İlaç ve Kimya Sanayi Ticaret Anonim Şirketi Manufacturer Registration\u002FApproval Number: TR-34-K-063184\n\nContents:\n\nSaccharomyces boulardii (5×10⁹ cfu\u002Fday) - 250 mg Probiotic Blend (3.5×10⁹ cfu\u002Fday) (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Streptococcus thermophilus) - 22.5 mg Prebiotic (Inulin) - 25 mg",[21,9],null,{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Placebo Administration","The use of a placebo in the control group",[25,15],[40],{"name":41,"affiliation":42,"role":43},"Burcu Karaduman","Biruni University, Faculty of Dentistry, Department of Periodontology","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":34,"email":49},"Burcu Karaduman, PhD","CONTACT","+90 444 8 276","bkaraduman@biruni.edu.tr",{"name":51,"role":47,"phone":48,"phoneExt":34,"email":52},"İrem Özdoğan, DDS","221115003@st.biruni.edu.tr",[54],{"facility":5,"status":34,"city":55,"state":55,"zip":56,"country":57,"countryCode":34,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Istanbul","34010","Turkey (Türkiye)",{"type":59,"coordinates":60},"Point",[61,62],28.94966,41.01384,{"lat":62,"lon":61},[65,66],{"name":46,"role":47,"phone":48,"phoneExt":34,"email":49},{"name":67,"role":47,"phone":48,"phoneExt":34,"email":52},"İrem Ozdogan, DDS",{"type":43,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Burcu KARADUMAN","Professor",[72],{"name":73,"class":6},"KU Leuven","100644529","effects-of-adjunctive-synbiotic-supplementation-to-non-surgical-periodontal-therapy-in-smokers-with-periodontitis-100644529",false,"NCT07672379","Effects of Adjunctive Synbiotic Supplementation to Non-Surgical Periodontal Therapy in Smokers With Periodontitis","Effects of Adjunctive Synbiotic Supplementation to Non-Surgical Periodontal Therapy on Clinical, Immunological, and Microbiological Parameters in Smokers With Periodontitis","Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Diagnosis of generalized Stage III\u002FIV Grade B\u002FC periodontitis\n* Willingness to participate in the study and provide informed consent\n* No periodontal treatment within the last 3 months\n* No use of antibiotics or anti-inflammatory drugs within the last 3 months\n* Not being pregnant or breastfeeding\n* Presence of at least 20 teeth\n* Body mass index (BMI) between 18.5 and 30 kg\u002Fm²\n\nExclusion Criteria:\n\n* Failure to meet voluntary participation requirements\n* Presence of systemic diseases affecting the periodontium or immune response\n* Use of additional dietary supplements\n* Pregnancy or breastfeeding\n* Use of immunosuppressive medications Individuals who may have difficulty complying with the study protocol","ALL","18 Years","65 Years",{"count":85,"type":86},92,"ESTIMATED","INTERVENTIONAL",[89],"NA","The aim of this study is to evaluate the effects of adjunctive synbiotic supplementation combined with non-surgical periodontal therapy in smokers with periodontitis. The main questions this study aims to answer are:\n\nDoes adjunctive synbiotic supplementation improve clinical periodontal parameters in smokers with periodontitis? Does adjunctive synbiotic supplementation affect immunological and microbiological parameters associated with periodontal disease?\n\nSystemically healthy smokers and non-smokers diagnosed with generalized Stage III-IV Grade B\u002FC periodontitis will be included in the study. Participants will first be divided into two main groups according to smoking status (smokers and non-smokers). These groups will then be further divided into two subgroups according to the use of synbiotic or placebo capsules. Therefore, the study will consist of four groups in total. The sample size of the study was determined as 92 participants, with 23 participants included in each group.\n\nAll participants will receive non-surgical periodontal therapy (NSPT) at baseline. In addition to NSPT, participants will use either synbiotic or placebo capsules once daily for 90 days.\n\nTo evaluate clinical periodontal, immunological, and microbiological parameters, periodontal measurements will be performed, and saliva and subgingival plaque samples will be collected. In addition, stool samples will be collected from participants to evaluate the effects of synbiotic supplementation on the gastrointestinal microbiota, and microbiota analyses will be performed.\n\nAll samples will be collected again and evaluated at the third month following non-surgical periodontal therapy.",[92],"Periodontal Disease",[94,95,96,97],"Periodontitis","Non-surgical periodontal treatment","Synbiotic","Probiotic","NOT_YET_RECRUITING","2026-06-24",{"date":101,"type":102},"2026-06-26","ACTUAL",{"date":104,"type":86},"2026-07-06",{"date":106,"type":86},"2027-10-06",{"name":5,"class":6},1]