[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659242":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":23,"studyPopulation":24,"armGroups":25,"interventions":19,"overallOfficials":19,"centralContacts":32,"locations":38,"responsibleParty":53,"collaborators":19,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":19,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":19,"studyType":71,"phases":19,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":41,"whyStopped":19,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Necmettin Erbakan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":19},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Salivary Porphyromonas gingivalis Burden","Porphyromonas gingivalis burden in unstimulated whole saliva will be quantitatively assessed using real-time polymerase chain reaction (qPCR). Bacterial burden will be reported using the quantitative output of the assay, such as bacterial copy number or bacterial load normalized to total bacterial load.","Baseline",{"measure":14,"description":15,"timeFrame":12},"Salivary Fusobacterium nucleatum Burden","Fusobacterium nucleatum burden in unstimulated whole saliva will be quantitatively assessed using real-time polymerase chain reaction (qPCR). Bacterial burden will be reported using the quantitative output of the assay, such as bacterial copy number or bacterial load normalized to total bacterial load.",{"measure":17,"description":18,"timeFrame":12},"Salivary Tannerella forsythia Burden","Tannerella forsythia burden in unstimulated whole saliva will be quantitatively assessed using real-time polymerase chain reaction (qPCR). Bacterial burden will be reported using the quantitative output of the assay, such as bacterial copy number or bacterial load normalized to total bacterial load.",null,{"allocation":19,"interventionModel":19,"interventionModelDescription":19,"primaryPurpose":19,"observationalModel":21,"timePerspective":22,"maskingInfo":19},"CASE_CONTROL","PROSPECTIVE","This is a prospective, matched case-control observational study conducted at Necmettin Erbakan University. The study population will consist of pregnant women followed at the Department of Obstetrics and Gynecology. Participants will be enrolled after providing written informed consent.\n\nThe study is planned to include 160 participants: 80 pregnant women diagnosed with missed abortion and 80 pregnant women with an ongoing uncomplicated pregnancy. Control participants will be matched to cases according to age within approximately 2 years and gestational age within approximately 1 week.\n\nWomen aged 18 to 40 years at 20 weeks of gestation or earlier will be eligible. Participants with detected fetal chromosomal or genetic abnormalities, current smoking or alcohol use, diabetes mellitus, hypertension, autoimmune disease, antibiotic use within the previous 3 months, induced abortion, or multiple pregnancy will be excluded.\n\nFor the missed abortion group, saliva sampling and periodontal examination will be performed after the diagnosis of missed abortion has been confirmed and before uterine evacuation, curettage, or medical treatment. For the control group, saliva samples and periodontal measurements will be obtained during routine pregnancy follow-up.\n\nUnstimulated whole saliva will be collected before periodontal examination to minimize contamination related to probing-induced bleeding. Salivary periodontal pathogen burden will be evaluated using quantitative real-time polymerase chain reaction. The target microorganisms will include Porphyromonas gingivalis, Fusobacterium nucleatum, and Tannerella forsythia. Salivary concentrations of IL-1β, IL-6, TNF-α, MMP-8, and prostaglandin E2 will also be assessed using validated immunoassay methods.\n\nSerum samples will be obtained only from residual blood remaining after routine clinically indicated obstetric laboratory testing. No additional venous blood collection will be performed solely for research purposes. Serum levels of CRP, IL-1β, IL-6, TNF-α, MMP-8, and prostaglandin E2 will be evaluated.\n\nRoutine complete blood count parameters will also be recorded. These data will be used to calculate systemic inflammatory indices, including the neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, monocyte-to-lymphocyte ratio, mean platelet volume-to-platelet ratio, and systemic immune-inflammation index.\n\nA comprehensive periodontal examination will be performed, including probing pocket depth, clinical attachment level, bleeding on probing, gingival index, plaque index, gingival recession, tooth mobility, furcation involvement, and missing tooth status.\n\nIn the missed abortion group, routine genetic examination results from abortus material will be reviewed. Genetic assessment performed as part of routine clinical care includes evaluation of selected autosomal chromosomes and sex chromosomes using qPCR\u002FQF-PCR and STR-based methods, together with assessment for maternal cell contamination. Cases with detected fetal chromosomal abnormalities or unreliable fetal genetic results will not be included in the main analysis.\n\nParticipants in the control group will be followed through routine obstetric records to verify continuation of pregnancy through at least 20 weeks of gestation and, when feasible, through 24 weeks. Participants who develop missed abortion, spontaneous abortion, detected fetal chromosomal abnormality, or a major obstetric complication before the predefined confirmation point will be excluded from the control-group analysis.\n\nThe primary objective is to assess the relationship between periodontal infection and missed abortion after exclusion of detected major fetal chromosomal abnormalities. Additional objectives are to compare local and systemic inflammatory biomarkers between groups and to investigate associations among periodontal pathogen burden, periodontal clinical status, inflammatory mediators, and prostaglandin E2.","The study population will consist of pregnant women aged 18-40 years at 20 weeks of gestation or earlier who are followed at the Department of Obstetrics and Gynecology, Necmettin Erbakan University. The case group will include women diagnosed with missed abortion who meet the eligibility criteria and have no detected fetal chromosomal abnormalities based on the available routine genetic evaluation. The control group will include women with an ongoing uncomplicated pregnancy and will be matched to cases according to age (±2 years) and gestational age (±1 week).",[26,29],{"label":27,"type":19,"description":28,"interventionNames":19},"Missed Abortion Group","Pregnant women aged 18-40 years at 20 weeks of gestation or earlier who are diagnosed with missed abortion and meet the study eligibility criteria. Cases with detected fetal chromosomal abnormalities or unreliable fetal genetic results will be excluded from the main analysis. Study assessments will be performed after confirmation of missed abortion and before uterine evacuation, curettage, or medical treatment.",{"label":30,"type":19,"description":31,"interventionNames":19},"Healthy Pregnancy Control Group","Pregnant women aged 18-40 years with an ongoing uncomplicated pregnancy at 20 weeks of gestation or earlier. Control participants will be matched to participants in the missed abortion group according to age (±2 years) and gestational age (±1 week). Pregnancy continuation will be verified through at least 20 weeks of gestation and, when feasible, through 24 weeks.",[33],{"name":34,"role":35,"phone":36,"phoneExt":19,"email":37},"Osman Babayiğit","CONTACT","+905063208474","obabayigit@erbakan.edu.tr",[39],{"facility":40,"status":41,"city":42,"state":42,"zip":43,"country":44,"countryCode":19,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Necmettin Erbakan University Faculty of Medicine, Department of Obstetrics and Gynecology","RECRUITING","Konya","42090","Turkey (Türkiye)",{"type":46,"coordinates":47},"Point",[48,49],32.48464,37.87135,{"lat":49,"lon":48},[52],{"name":34,"role":35,"phone":36,"phoneExt":19,"email":37},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Osman Babayigit","Associate Professor","100659242","periodontal-pathogens-and-inflammatory-biomarkers-in-missed-abortion-100659242",false,"NCT07864220","Periodontal Pathogens and Inflammatory Biomarkers in Missed Abortion","Salivary Periodontal Pathogen Burden and the Inflammatory-Prostaglandin E2 Axis in Missed Abortion Cases Without Fetal Chromosomal Abnormalities: A Case-Control Study","Inclusion Criteria:\n\n* Female participants aged 18-40 years Pregnancy at 20 weeks of gestation or earlier For the case group: diagnosis of missed abortion For the control group: ongoing uncomplicated pregnancy Provision of written informed consent\n\nExclusion Criteria:\n\n* Detected fetal chromosomal or genetic abnormality Current smoking Alcohol use Diabetes mellitus Hypertension Autoimmune disease Antibiotic use within the previous 3 months Induced abortion Multiple pregnancy",true,"FEMALE","18 Years","40 Years",{"count":69,"type":70},160,"ESTIMATED","OBSERVATIONAL","This observational case-control study will investigate whether periodontal infection and inflammation are associated with missed abortion in pregnancies without detected major fetal chromosomal abnormalities.\n\nA total of 160 pregnant women aged 18 to 40 years and at 20 weeks of gestation or earlier are planned to be enrolled. The study will include 80 women diagnosed with missed abortion and 80 women with an ongoing uncomplicated pregnancy matched according to age and gestational week.\n\nParticipants will undergo a clinical periodontal examination, and unstimulated saliva samples will be collected. Saliva will be analyzed for selected periodontal bacteria, including Porphyromonas gingivalis, Fusobacterium nucleatum, and Tannerella forsythia, as well as inflammatory biomarkers.\n\nSerum obtained from blood samples already collected as part of routine obstetric care will be used to measure inflammatory biomarkers, including IL-1β, IL-6, TNF-α, CRP, MMP-8, and prostaglandin E2. No additional blood sample will be collected solely for this study. Routine complete blood count results will also be used to calculate systemic inflammatory indices.\n\nFor participants with missed abortion, study samples and periodontal assessments will be obtained after the diagnosis has been confirmed and before uterine evacuation or medical treatment. Routine fetal genetic test results will be reviewed, and cases with detected chromosomal abnormalities included in the clinical genetic assessment will be excluded from the main analysis.\n\nThe study aims to determine whether periodontal pathogen burden, periodontal disease, and local and systemic inflammatory responses differ between women with missed abortion and women with ongoing uncomplicated pregnancies.",[74,75],"Missed Abortion","Periodontitis",[77,75,78,79],"Missed abortion","Pregnancy loss","Pregnancy","2026-10-04",{"date":82,"type":83},"2026-10-07","ACTUAL",{"date":85,"type":83},"2026-08-01",{"date":87,"type":70},"2027-06-15",{"name":5,"class":6},1]