[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656403":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":36,"armGroups":37,"interventions":33,"overallOfficials":33,"centralContacts":49,"locations":55,"responsibleParty":72,"collaborators":33,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":33,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":33,"studyType":90,"phases":33,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":58,"whyStopped":33,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Abant Izzet Baysal University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Total Amount of MFN1 in Gingival Crevicular Fluid","The total amount of mitofusin-1 (MFN1) in pooled gingival crevicular fluid samples will be measured using a commercial enzyme-linked immunosorbent assay (ELISA). MFN1 amounts will be compared across the four groups defined by periodontal health or periodontitis and smoking status.","Baseline, at the sample collection visit 24-72 hours after the periodontal examination and before periodontal treatment.",[14,18,22,25,28,30],{"measure":15,"description":16,"timeFrame":17},"Total Amount of NLRP3 in Gingival Crevicular Fluid","The total amount of NLRP3 protein in pooled gingival crevicular fluid samples will be measured using a commercial enzyme-linked immunosorbent assay (ELISA). NLRP3 amounts will be compared across the four groups defined by periodontal health or periodontitis and smoking status.","The total amount of NLRP3 protein in pooled gingival crevicular fluid samples will be measured using a commercial enzyme-linked immunosorbent assay (ELISA). NLRP3 amounts will be compared across the four groups defined by periodontal health or periodonti",{"measure":19,"description":20,"timeFrame":21},"Full-Mouth Mean Probing Depth","Probing depth will be measured in millimeters from the gingival margin to the base of the sulcus or periodontal pocket at six sites per tooth, excluding third molars. A full-mouth mean will be calculated for each participant. Values will be compared across the four study groups, and associations with gingival crevicular fluid MFN1 and NLRP3 amounts will be evaluated.","Baseline, at the initial periodontal examination before gingival crevicular fluid sampling and periodontal treatment.",{"measure":23,"description":24,"timeFrame":21},"Full-Mouth Mean Clinical Attachment Level","Clinical attachment level will be measured in millimeters from the cementoenamel junction to the base of the sulcus or periodontal pocket at six sites per tooth, excluding third molars. A full-mouth mean will be calculated for each participant. Values will be compared across the four study groups, and associations with gingival crevicular fluid MFN1 and NLRP3 amounts will be evaluated.",{"measure":26,"description":27,"timeFrame":21},"Percentage of Sites With Bleeding on Probing","Bleeding on probing will be recorded at six sites per tooth, excluding third molars. The number of bleeding sites will be divided by the total number of examined sites and multiplied by 100 to calculate a full-mouth percentage for each participant. Scores range from 0% to 100%, with higher values indicating more widespread gingival bleeding. Values will be compared across the four study groups, and associations with gingival crevicular fluid MFN1 and NLRP3 amounts will be evaluated.",{"measure":29,"description":29,"timeFrame":21},"Full-Mouth Mean Plaque Index",{"measure":31,"description":32,"timeFrame":21},"Full-Mouth Mean Gingival Index","Gingival inflammation will be assessed using the Löe and Silness Gingival Index at four surfaces per tooth, excluding third molars. Scores range from 0 to 3, with higher scores indicating more severe gingival inflammation. A full-mouth mean will be calculated for each participant. Values will be compared across the four study groups, and associations with gingival crevicular fluid MFN1 and NLRP3 amounts will be evaluated.",null,{"allocation":33,"interventionModel":33,"interventionModelDescription":33,"primaryPurpose":33,"observationalModel":6,"timePerspective":35,"maskingInfo":33},"CROSS_SECTIONAL","Adults aged 18-65 years attending the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University, Bolu, Türkiye, will be assessed for eligibility. Participants will have at least 20 natural teeth and either periodontal health on an intact periodontium or Stage III or Stage IV periodontitis. Four groups will be formed according to periodontal status and cigarette smoking history: periodontally healthy nonsmokers, periodontally healthy smokers, nonsmokers with periodontitis, and smokers with periodontitis.",[38,41,43,46],{"label":39,"type":33,"description":40,"interventionNames":33},"Periodontally Healthy Nonsmokers","Adults aged 18-65 years with periodontal health on an intact periodontium, defined as probing depths ≤3 mm, full-mouth bleeding on probing \\\u003C10%, and no interdental clinical attachment loss or radiographic bone loss attributable to periodontitis. Participants will have smoked fewer than 100 cigarettes in their lifetime and will not currently use any tobacco or nicotine products. Periodontal measurements and gingival crevicular fluid sampling will be performed to assess MFN1 and NLRP3.",{"label":42,"type":33,"description":40,"interventionNames":33},"Periodontally Healthy Smokers",{"label":44,"type":33,"description":45,"interventionNames":33},"Nonsmokers With Periodontitis","Adults aged 18-65 years with Stage III or Stage IV periodontitis according to the 2017 periodontal disease classification. Participants will have smoked fewer than 100 cigarettes in their lifetime and will not currently use any tobacco or nicotine products. Periodontal measurements and gingival crevicular fluid sampling will be performed before periodontal treatment to assess MFN1 and NLRP3. Routine periodontal treatment will be planned after sample collection.",{"label":47,"type":33,"description":48,"interventionNames":33},"Smokers With Periodontitis","Adults aged 18-65 years with Stage III or Stage IV periodontitis according to the 2017 periodontal disease classification. Participants will be current smokers who have regularly smoked at least 10 cigarettes per day for at least 5 years. Periodontal measurements and gingival crevicular fluid sampling will be performed before periodontal treatment to assess MFN1 and NLRP3. Routine periodontal treatment will be planned after sample collection.",[50],{"name":51,"role":52,"phone":53,"phoneExt":33,"email":54},"Zeynep Akgul, DDS, PhD","CONTACT","05304253826","zeyneppakgulakgul@gmail.com",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":33,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Faculty of Dentistry, Bolu Abant İzzet Baysal University, Department of Periodontics","RECRUITING","Bolu","Central","14100","Turkey (Türkiye)",{"type":64,"coordinates":65},"Point",[66,67],31.60611,40.73583,{"lat":67,"lon":66},[70],{"name":71,"role":52,"phone":53,"phoneExt":33,"email":33},"Zeynep Akgul",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Zeynep AKGÜL","Assist Prof","100656403","smoking-and-gingival-crevicular-fluid-mfn1-and-nlrp3-levels-in-periodontal-health-and-periodontitis-100656403",false,"NCT07826728","SMOKING AND GINGIVAL CREVICULAR FLUID MFN1 AND NLRP3 LEVELS IN PERIODONTAL HEALTH AND PERIODONTITIS","ASSOCİATİON BETWEEN SMOKİNG AND GİNGİVAL CREVİCULAR FLUİD MFN1 AND NLRP3 LEVELS İN INDİVİDUALS WİTH PERİODONTAL HEALTH OR PERİODONTİTİS","Inclusion Criteria:\n\n* Aged 18-65 years. At least 20 natural teeth. For the periodontal health groups: periodontal health on an intact periodontium, with probing depths ≤3 mm, full-mouth bleeding on probing \\\u003C10%, and no interdental clinical attachment loss or radiographic bone loss attributable to periodontitis.\n\nFor the periodontitis groups: Stage III or Stage IV periodontitis according to the 2017 periodontal disease classification.\n\nFor the smoking groups: current cigarette smoking of at least 10 cigarettes per day for at least 5 years.\n\nFor the nonsmoking groups: fewer than 100 cigarettes smoked during the lifetime and no current use of tobacco or nicotine products.\n\nProvision of written informed consent.\n\nExclusion Criteria:\n\n* ormer cigarette smoking. Use of electronic cigarettes, heated tobacco products, nicotine pouches, or nicotine replacement products.\n\nUncontrolled diabetes, immunodeficiency, autoimmune or chronic inflammatory disease, or a serious systemic disease that may affect periodontal or mitochondrial responses.\n\nPregnancy or breastfeeding. Use of antibiotics, systemic corticosteroids, immunosuppressive medications, or regular anti-inflammatory medications within the previous 3 months.\n\nPeriodontal treatment within the previous 6 months. Acute oral infection, periodontal abscess, or local pathology affecting the sampling sites.\n\nGingival crevicular fluid samples contaminated with blood or saliva, or insufficient for ELISA analysis.",true,"ALL","18 Years","65 Years",{"count":88,"type":89},88,"ESTIMATED","OBSERVATIONAL","This observational study aims to examine the relationship between cigarette smoking and the levels of two proteins, mitofusin-1 (MFN1) and NLRP3, in the fluid found between the teeth and gums. These proteins are involved in processes related to cell function and inflammation.\n\nAdults aged 25-65 years will be included in four groups: periodontally healthy nonsmokers, periodontally healthy smokers, nonsmokers with periodontitis, and smokers with periodontitis. Periodontitis is a gum disease that damages the tissues and bone supporting the teeth.\n\nParticipants will provide information about their health and smoking history and undergo a periodontal examination. Small samples of fluid from around the gums will be collected using paper strips before periodontal treatment. The samples will be analyzed for MFN1 and NLRP3.\n\nResearchers will compare the amounts of these proteins across the four groups and examine their relationships with periodontal measurements and smoking history. No experimental medication or treatment will be assigned. Participants with periodontitis will be offered routine periodontal care after sample collection.",[93,94],"Periodontitis","Smoking",[96,97,98,99,100,101],"Periodontal health","Gingival crevicular fluid","Mitofusin-1","MFN1","NLRP3","Smoking exposure","2026-09-14",{"date":104,"type":105},"2026-09-17","ACTUAL",{"date":107,"type":105},"2026-08-15",{"date":109,"type":89},"2026-11-15",{"name":5,"class":6},1]