[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613132":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":44,"locations":50,"responsibleParty":66,"collaborators":34,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":34,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":34,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":53,"whyStopped":34,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Erzincan University","OTHER",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Control Group","SHAM_COMPARATOR","Periodontally healthy individuals with no clinical attachment loss, probing depth ≤3 mm, no radiographic bone loss, and low gingival and plaque index scores.",[13],"Other: Saliva Collection",{"label":15,"type":16,"description":17,"interventionNames":18},"Mild Periodontitis Group","EXPERIMENTAL","Non-smoking individuals diagnosed with Stage I-II periodontitis according to the AAP\u002FEFP 2018 classification, with clinical attachment loss of 1-4 mm and ≤15-33% radiographic bone loss.",[19,13],"Procedure: Non-surgical Periodontal Therapy (Scaling and Root Planing)",{"label":21,"type":16,"description":22,"interventionNames":23},"Severe Periodontitis Group","Non-smoking individuals diagnosed with Stage III-IV periodontitis according to the AAP\u002FEFP 2018 classification, with clinical attachment loss ≥5 mm and radiographic bone loss to the mid-advanced level of the root.",[19,13],{"label":25,"type":16,"description":26,"interventionNames":27},"Severe Periodontitis with Smoking Group","Individuals who meet the criteria for the Severe Periodontitis Group and are also regular smokers (at least 10 cigarettes per day for a minimum of 5 years).",[19,13],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"PROCEDURE","Non-surgical Periodontal Therapy (Scaling and Root Planing)","A standard periodontal treatment procedure that involves the removal of dental plaque and calculus (tartar) from the tooth surfaces and root pockets. This is followed by root planing to smooth the root surfaces, allowing the gingiva to heal and reattach to the tooth.",[15,21,25],null,{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Saliva Collection","Collection of unstimulated whole saliva. Participants will be asked to allow saliva to pool in the floor of the mouth and then passively drool into a sterile collection tube. A total of 1.5 ml of saliva will be collected from each participant.",[9,15,21,25],[40],{"name":41,"affiliation":42,"role":43},"Ömer F Okumuş, DDS,PhD","Erzincan Binali Yıldırım University, Faculty of Dentistry, Department of Periodontology","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":34,"email":49},"Ömer F. Okumuş, DDS,PhD","CONTACT","05532140969","okumus.omer24@gmail.com",[51],{"facility":52,"status":53,"city":54,"state":54,"zip":55,"country":56,"countryCode":34,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Erzincan Binali Yıldırım University Faculty of Dentistry","RECRUITING","Erzincan","24002","Turkey (Türkiye)",{"type":58,"coordinates":59},"Point",[60,61],39.49015,39.73919,{"lat":61,"lon":60},[64],{"name":65,"role":47,"phone":48,"phoneExt":34,"email":49},"Ömer Faruk Okumuş",{"type":67,"investigatorFullName":65,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","assistant professor","100613132","salivary-mitofusin-1-levels-in-periodontitis-associations-with-disease-severity-smoking-and-treatment-response-100613132",false,"NCT07262606","Salivary Mitofusin-1 Levels in Periodontitis: Associations With Disease Severity, Smoking, and Treatment Response","Inclusion Criteria:\n\n* Willing and able to provide written informed consent.\n* Systemically healthy (no history of diabetes mellitus, immunodeficiency, malignancy, or other systemic conditions that could affect periodontal status).\n* Have a minimum of 20 natural teeth (excluding third molars).\n* No antibiotic therapy or periodontal treatment in the last 6 months.\n\nFor Healthy Control Group:\n\nNo clinical attachment loss. Probing depth ≤ 3 mm. No radiographic evidence of bone loss. Low gingival and plaque index scores.\n\nFor Mild Periodontitis Group:\n\nDiagnosed with Stage I or II periodontitis according to the 2018 AAP\u002FEFP classification.\n\nClinical attachment loss of 1-4 mm. Radiographic bone loss of ≤15-33%. Non-smoker.\n\nFor Severe Periodontitis Group:\n\nDiagnosed with Stage III or IV periodontitis according to the 2018 AAP\u002FEFP classification.\n\nClinical attachment loss ≥ 5 mm. Radiographic bone loss to the mid-advanced level of the root. Non-smoker.\n\nFor Severe Periodontitis with Smoking Group:\n\nMeets all criteria for the Severe Periodontitis Group. Regular smoker (at least 10 cigarettes per day for a minimum of 5 years).\n\nExclusion Criteria:\n\n* Fewer than 20 natural teeth (excluding third molars).\n* Presence of any systemic disease (e.g., diabetes mellitus, immunological disorders, cancer).\n* Use of antibiotics or receiving periodontal treatment in the last 6 months.\n* Pregnancy or lactation.\n* For non-periodontitis groups (Healthy Control): Any signs of periodontitis.\n* For periodontitis groups (all): History of smoking cessation for at least 5 years (must be either a current regular smoker or a never-smoker, depending on the group definition).",true,"ALL","18 Years","65 Years",{"count":80,"type":81},104,"ESTIMATED","INTERVENTIONAL",[84],"NA","Periodontitis (gum inflammation) is a common disease worldwide. This study aims to investigate a novel biomarker, a protein called Mitofusin-1 (Mfn1), in saliva that may be associated with the severity of periodontitis and response to treatment. The study will include periodontally healthy individuals, individuals with mild to severe periodontitis, and smokers with severe periodontitis. Participants will receive saliva samples and undergo clinical periodontal examinations. Individuals with periodontitis will receive standard periodontal treatment, and changes in Mfn1 levels will be assessed 3 months after treatment. The study is expected to shed light on the potential utility of Mfn1 as a marker in the diagnosis and follow-up of periodontitis.",[87,88],"Periodontal Disease","Chronic Periodontitis (Disorder)",[90,91,92,93,94],"Mitofusin-1","Saliva","Biomarker","Periodontal Treatment","Smoking","2025-12-01",{"date":97,"type":98},"2025-12-03","ACTUAL",{"date":100,"type":98},"2025-11-01",{"date":102,"type":81},"2026-11-01",{"name":65,"class":6},1]