[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597106":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":21,"responsibleParty":35,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":10,"eligibilityCriteria":43,"healthyVolunteers":44,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":51,"studyType":52,"phases":10,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":24,"whyStopped":10,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Bezmialem Vakif University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Pregnant Women",null,"This group includes 15 healthy pregnant women aged 18-40 with uncomplicated pregnancies. Saliva samples are collected at four time points: during the first (0-13 weeks), second (14-27 weeks), and third trimesters (28 weeks and later), and at 6-8 weeks postpartum. No medical intervention is applied. The aim is to analyze changes in periodontal parameters and salivary metabolite profiles over time using untargeted metabolomics via LC-MS\u002FMS.",{"label":13,"type":10,"description":14,"interventionNames":10},"Non-Pregnant Healthy Controls","This group includes 15 systemically healthy, non-pregnant women aged 18-40 with regular menstrual cycles and no history of pregnancy in the past 6 months. Saliva and periodontal measurements are collected during the early follicular phase of the menstrual cycle. These participants serve as the control group for comparative evaluation of salivary metabolomic profiles and periodontal health status.",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Cansu Can Yasar, Periodontist","CONTACT","+905453153495","cansu.ysr@gmail.com",[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":10,"cosmosGeoPoint":29,"geoPoint":34,"contacts":10},"Bezmialem Vakıf University, Faculty of Dentistry and Faculty of Medicine, Istanbul","RECRUITING","Istanbul","Fatih","34093","Turkey (Türkiye)",{"type":30,"coordinates":31},"Point",[32,33],28.94966,41.01384,{"lat":33,"lon":32},{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100597106","metabolic-profiling-of-saliva-in-pregnancy-and-periodontal-disease-100597106",false,"NCT07054177","Metabolic Profiling of Saliva in Pregnancy and Periodontal Disease","Salivary Metabolomics of Pregnancy and Periodontal Disease Related Metabolic Pathways","Inclusion Criteria:\n\n* Age between 18 and 40 years\n* No history of systemic disease or chronic infection\n* No use of antibiotics or anti-inflammatory drugs in the last 3 months\n* Non-smoker and non-alcohol user\n* Willingness to participate by signing the informed consent form\n\nAdditional Criteria for Pregnant Volunteers:\n\n* Singleton pregnancy (no multiple gestation)\n* Pregnancy progressing without complications (e.g., no diagnosis of preeclampsia, gestational diabetes, or threatened preterm labor)\n* Gestational age confirmed by ultrasound\n\nAdditional Criteria for Non-Pregnant Control Group:\n\n* No history of pregnancy in the past 6 months\n* Regular menstrual cycles\n* No history of hormonal disorders (e.g., polycystic ovary syndrome, thyroid dysfunction)\n\nExclusion Criteria:\n\n* Use of anti-inflammatory or antimicrobial treatments in the past 3 months\n* Smoking or alcohol consumption\n* Body mass index (BMI) \\> 30 kg\u002Fm²\n* Presence of systemic diseases including diabetes mellitus, hyperprolactinemia, congenital adrenal hyperplasia, androgen-secreting tumors, thyroid dysfunction, Cushing's syndrome, hypertension, liver or kidney dysfunction\n* Use of medications that may affect metabolic or hormonal parameters, such as oral contraceptives, steroid hormones, antihypertensives, or insulin-sensitizing drugs\n* Periodontal treatment in the past 6 months\n* Use of medications known to affect periodontal status (e.g., phenytoin, calcium channel blockers, cyclosporine, warfarin, NSAIDs, aspirin \\> 81 mg)\n* Active infectious diseases such as hepatitis, HIV, or tuberculosis",true,"FEMALE","18 Years","40 Years",{"count":49,"type":50},30,"ESTIMATED","9 Months","OBSERVATIONAL","This study aims to better understand how pregnancy affects the health of the gums and tissues that support the teeth. During pregnancy, hormone levels (like estrogen and progesterone) increase significantly. These hormonal changes can cause many changes in the body, including in the mouth. Some pregnant women may notice that their gums become swollen, red, or bleed more easily - this is called pregnancy gingivitis. It happens more often during the second and third trimesters and usually improves after birth. Even if a pregnant person has good oral hygiene, hormonal changes may still make the gums more sensitive to plaque and bacteria. Scientists believe that these changes in gum health are linked to how the body responds to hormones, bacteria in the mouth, and changes in the immune system. To explore this further, saliva samples will be collected from:\n\n* Pregnant women during their 1st, 2nd, and 3rd trimesters\n* The same women again 6-8 weeks after giving birth\n* A group of non-pregnant, healthy women as a comparison group The investigators will use a scientific method called untargeted metabolomics to study these saliva samples. This method helps looking at small substances (called metabolites) in saliva to see if there are any patterns related to pregnancy and gum health.\n\nThe goal is to identify biological changes that happen during pregnancy and understand how they might affect the gums. This research will help improve early detection and prevention of gum problems during pregnancy in the future.",[55,56],"Pregnancy","Gingivitis and Periodontal Diseases",[58,59,60,61,62,63],"pregnancy","gingivitis","periodontal disease","saliva","metabolomics","LC-MS\u002FMS","2025-07-18",{"date":66,"type":67},"2025-07-23","ACTUAL",{"date":69,"type":67},"2025-06-24",{"date":71,"type":50},"2026-04",{"name":5,"class":6},1]