[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054173":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":10,"responsibleParty":25,"collaborators":10,"id":27,"slug":10,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":10,"eligibilityCriteria":32,"healthyVolunteers":33,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":10,"studyType":40,"phases":10,"briefSummary":41,"conditions":42,"keywords":46,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":10},{"fullName":5,"class":6},"Saglik Bilimleri Universitesi","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Pregnant Women Without Periodontitis",null,"Pregnant women aged 18-40 years with singleton pregnancies between 28 and 32 weeks of gestation who do not have periodontitis. This cohort includes periodontally healthy participants and participants with gingivitis who do not meet the diagnostic criteria for periodontitis according to the 2017 World Workshop Classification.",{"label":13,"type":10,"description":14,"interventionNames":10},"Pregnant Women With Periodontitis","Pregnant women aged 18-40 years with singleton pregnancies between 28 and 32 weeks of gestation who are diagnosed with periodontitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.",[16,21],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Erkan Özcan, Prof","CONTACT","+90 312 567 1500","erkan.ozcan@sbu.edu.tr",{"name":22,"role":18,"phone":23,"phoneExt":10,"email":24},"Sayna Behkar, Dr","+90 534 777 7430","saynabehkar@gmail.com",{"type":26,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100054173",false,"NCT07699978","Maternal Periodontal Inflammation and Pregnancy Outcomes: Salivary and Amniotic Biomarkers","The Relationship Between Maternal Periodontal Inflammation and Pregnancy Outcomes: Evaluation Using Inflammatory and Oxidative Stress Biomarkers in Saliva and Amniotic Fluid","Inclusion Criteria:\n\nPregnant women between 28 and 32 weeks of gestation Age 18 to 40 years Singleton pregnancy Systemically healthy Normal gestational diabetes screening (oral glucose tolerance test within the hospital reference range) Receiving only routine prenatal vitamin and iron supplementation (no therapeutic medications) Low-risk pregnancy No history of chorioamnionitis No periodontal treatment within the previous 6 months Able and willing to provide written informed consent\n\nExclusion Criteria:\n\nMultiple pregnancy Use of antibiotics or anti-inflammatory medications during pregnancy Current smoking or alcohol consumption Presence of an acute infection Placental pathology Major fetal anomaly High-risk pregnancy as determined by the obstetrician Refusal or inability to provide informed consent",true,"FEMALE","18 Years","40 Years",{"count":38,"type":39},80,"ESTIMATED","OBSERVATIONAL","Periodontal disease is a chronic inflammatory condition that affects the tissues supporting the teeth and may contribute to systemic inflammation and oxidative stress. Increasing evidence suggests that maternal inflammation during pregnancy may be associated with adverse pregnancy outcomes, including preterm birth. However, the biological mechanisms linking maternal periodontal inflammation to the intrauterine environment remain unclear.\n\nThis prospective observational cohort study aims to investigate the relationship between maternal periodontal status and inflammatory and oxidative stress biomarkers measured in both saliva and amniotic fluid. Eighty healthy pregnant women between 28 and 32 weeks of gestation will be recruited from the Obstetrics and Gynecology Clinic of Gulhane Training and Research Hospital. Participants will undergo a comprehensive periodontal examination and provide unstimulated saliva samples. Amniotic fluid samples will be collected during delivery as part of routine obstetric care, without any additional invasive procedures.\n\nThe concentrations of 8-hydroxy-2'-deoxyguanosine (8-OHdG), malondialdehyde (MDA), interleukin-6 (IL-6), and matrix metalloproteinase-8 (MMP-8) will be measured in saliva and amniotic fluid using enzyme-linked immunosorbent assay (ELISA). Pregnancy outcomes, including gestational age at delivery, birth weight, and pregnancy complications, will also be recorded.\n\nThe study will evaluate whether maternal periodontal inflammation is associated with changes in inflammatory and oxidative stress biomarkers in saliva and amniotic fluid and whether these biomarkers are related to pregnancy outcomes. The findings may improve understanding of the biological relationship between oral health and pregnancy and may contribute to the identification of biomarkers associated with adverse pregnancy outcomes.",[43,44,45],"Periodontal Disease","Pregnancy","Preterm Birth",[47,44,45,48,49,50,51,52,53],"Periodontitis","Oxidative Stress","Inflammation","Saliva","Amniotic Fluid","8-Hydroxy-2'-deoxyguanosine (8-OHdG)","Interleukin-6 (IL-6)","NOT_YET_RECRUITING","2026-07-07",{"date":57,"type":58},"2026-07-13","ACTUAL",{"date":60,"type":39},"2026-08-20",{"date":62,"type":39},"2027-08-15",{"name":5,"class":6}]