[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474143":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":54,"centralContacts":54,"locations":67,"responsibleParty":78,"collaborators":54,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":54,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":54,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":115,"whyStopped":54,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Ondokuz Mayıs University","OTHER",[8,16,22,27,31,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 (HH)","ACTIVE_COMPARATOR","17 systemically healthy + periodontally healthy (normoglycemic)",[13,14,15],"Diagnostic Test: ELISA Test","Other: Periodontal Examination","Other: Saliva Sample Collection",{"label":17,"type":18,"description":19,"interventionNames":20},"Group 2 (HP)","EXPERIMENTAL","17 systemic healthy + grade A periodontitis",[21,13,14,15],"Procedure: Non-surgical periodontal treatment",{"label":23,"type":10,"description":24,"interventionNames":25},"Group 3 (T2D+H)","17 T2DM (HbA1c\\\u003C%7) + periodontally healthy",[13,14,15,26],"Diagnostic Test: HbA1c Level",{"label":28,"type":18,"description":29,"interventionNames":30},"Group 4 (T2D+P)","17 T2DM (HbA1c\\\u003C%7) + grade B periodontitis",[21,13,14,15,26],{"label":32,"type":10,"description":33,"interventionNames":34},"Group 5 (T2D-H)","17 T2DM (HbA1c≥%7) + periodontally healthy",[13,14,15,26],{"label":36,"type":18,"description":37,"interventionNames":38},"Group 6 (T2D-P)","17 T2DM (HbA1c≥%7) + grade C periodontitis",[21,13,14,15,26],[40,49,55,59,63],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"PROCEDURE","Non-surgical periodontal treatment","Routine non-surgical periodontal treatment will be applied to patients with periodontitis. The main aim of non-surgical periodontal treatment is to protect, heal and maintain the existing dentition. For this purpose, using manual, sonic or ultrasonic instruments, microbial dental plaque and calculus are removed by tooth surface cleaning and root surface straightening.",[17,28,36],[46,47,48],"phase I periodontal therapy","scaling and root planing","full mouth debridement",{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"DIAGNOSTIC_TEST","ELISA Test","C1P and PGE2 levels in saliva samples obtained, and will be examined by ELISA test.",[9,17,23,28,32,36],null,{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":54},"Periodontal Examination","All diagnostic procedures were performed with examination instruments (periodontal probe, dental mirror, x-ray device, etc.). Periodontal clinical index measurements (PI, GI, BOP, PPD, CAL) recorded from all teeth. Routine panoramic radiographs were taken from all patients to determine alveolar bone resorption. Vertical\u002Fhorizontal bone losses on the radiographs were evaluated and used in the diagnosis of periodontitis.",[9,17,23,28,32,36],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":54},"Saliva Sample Collection","Saliva samples were collected from all subjects in the morning. Unstimulated saliva from each patient was collected by standard defined spitting method without stimulation.",[9,17,23,28,32,36],{"type":50,"name":64,"description":65,"armGroupLabels":66,"otherNames":54},"HbA1c Level","Measurement of HbA1c levels from blood tests",[23,28,32,36],[68],{"facility":69,"status":54,"city":70,"state":54,"zip":54,"country":71,"countryCode":54,"cosmosGeoPoint":72,"geoPoint":77,"contacts":54},"Ondokuz Mayis University","Samsun","Turkey (Türkiye)",{"type":73,"coordinates":74},"Point",[75,76],36.3361,41.27976,{"lat":76,"lon":75},{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"PRINCIPAL_INVESTIGATOR","SELMAN YILMAZ CICEK","Principal Investigator","100474143","salivary-c1p-and-pge2-levels-in-periodontitis-patients-with-t2dm-and-effect-of-non-surgical-periodontal-treatment-100474143",false,"NCT05454059","Salivary C1P and PGE2 Levels in Periodontitis Patients With T2DM and Effect of Non-Surgical Periodontal Treatment","Investigation of Salivary Ceramide-1-Phosphate and Prostaglandin E2 Levels in Periodontitis Patients With Poorly and Well-Controlled Type 2 Diabetes and Effect of Non-Surgical Periodontal Treatment: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Between the ages of 30-65\n* Have not received periodontal treatment in the last 6 months,\n* Does not have any systemic disease and does not use drugs,\n* Not using local or systemic antibiotics in the last 3 months,\n* HbA1c \\\u003C%7 for the controlled T2DM group,\n* HbA1c ≥7% for the uncontrolled T2DM group,\n* For female patients who are not in the pregnancy or lactation period,\n* Non-smoker,\n* Not regularly using mouthwash\u002Fmouthwash.\n\nExclusion Criteria:\n\n* Not being willing to participate in the study,\n* Under 30 years old, over 65 years old\n* Having any systemic disease affecting the periodontal condition,\n* To use any medication that may affect the inflammatory process in the last 3 months,\n* Using local or systemic antibiotics in the last 3 months,\n* To have had periodontal treatment in the last 6 months,\n* Being in pregnancy or lactation period for female patients,\n* Using mouthwash regularly\n* Smoking",true,"ALL","30 Years","65 Years",{"count":94,"type":95},102,"ACTUAL","INTERVENTIONAL",[98],"NA","Diabetes and periodontal disease are the most common chronic multifactorial and inflammatory diseases in humans, and there is a bidirectional relationship between type 2 diabetes and periodontitis. With the negative effects of the control of these two diseases, it results in an increase in the severity of diabetes and periodontitis, and they affect many systems together. To elucidate the role of ceramide, which is one of the possible biochemical mechanisms between diabetes and the degree of glycemic control and periodontitis, in inflammation. Aim of this study is the measurement of C1P and PGE2 in saliva and the effect of non-surgical periodontal treatment, which includes the degree of control of diabetes, oral hygiene education, tooth surface cleaning and root surface arrangement, on 3 months.\n\nA total of 102 subjects were included. Clinical periodontal measurements, saliva samples were collected from each individual at baseline and 3 months after non-surgical periodontal treatmet in periodontitis groups. Salivary C1P and PGE2 levels were determined by enzyme-linked immunosorbent assay (ELISA) method.",[101,102],"Periodontitis","Type 2 Diabetes",[104,105,106,107,46,108,109,110,111,112,113,114],"saliva","prostaglandin e2","ceramide-1-phosphate","non-surgical periodontal treatment","saliva biomarker","metabolic control","HbA1c","PGE2","C1P","periodontitis","type 2 diabetes mellitus","COMPLETED","2022-07-06",{"date":118,"type":95},"2022-07-12",{"date":120,"type":95},"2020-10-22",{"date":122,"type":95},"2022-06-22",{"name":5,"class":6},1]