[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611095":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":23,"locations":29,"responsibleParty":46,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":10,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":68,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Istanbul University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with primary hypertension",null,"This group includes adolescents aged 10-18 years who have been clinically diagnosed with primary hypertension based on repeated office blood pressure measurements according to pediatric hypertension guidelines. Participants will undergo standardized assessments including oral examination, blood pressure measurements, salivary collection, and laboratory analyses. Laboratory procedures include: oral microbiota profiling through 16S rRNA gene sequencing, quantification of nitrate-reducing bacterial activity, measurement of salivary pH, total protein concentration, and lysozyme activity. No therapeutic intervention will be administered. All procedures are observational and aim to characterize microbial and biochemical markers associated with primary hypertension.",[13],"Other: No active intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Healthy controls","This group includes healthy adolescents aged 10-18 years with no history of primary or secondary hypertension, chronic systemic disease, or regular medication use affecting cardiovascular or oral microbiome physiology. Participants will undergo standard clinical assessments identical to the hypertension group, including oral examination, salivary collection, and blood pressure measurement. Laboratory procedures will include salivary microbiota analysis (16S rRNA sequencing), assessment of nitrate-reducing bacterial activity, salivary pH, total protein concentration, and lysozyme activity. This cohort serves as the normative comparison group to evaluate microbial and biochemical differences associated with primary hypertension. No intervention will be administered.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"No active intervention","This is an observational study with no active intervention. No drug, device, behavioral, dietary, surgical, or diagnostic intervention is administered to participants. All study procedures, including oral examination, salivary sampling, pH measurement, biochemical tests, and blood pressure assessment, are non-interventional and part of standard clinical evaluation. The study only aims to observe natural variations in oral microbiota composition, nitrate-reducing activity, and blood pressure without changing participants' medical care.",[15,9],[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Yelda Kasimoglu Assoc. Prof.","CONTACT","+90 533 623 39 78","yelda.kasimoglu@iu.edu.tr",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":10,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Istanbul University Faculty of Dentistry","RECRUITING","Istanbul","Fatih","34093","Turkey (Türkiye)",{"type":38,"coordinates":39},"Point",[40,41],28.94966,41.01384,{"lat":41,"lon":40},[44],{"name":45,"role":26,"phone":27,"phoneExt":10,"email":28},"Yelda Kasimoglu, Assoc. Prof.",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Yelda Kasımoğlu","Assoc. Prof.",[51],{"name":52,"class":53},"Istanbul University Scientific Research Projects Coordination Unit- Pending","UNKNOWN","100611095","dietary-nitrate-and-the-oral-microbiome-in-children-with-primary-hypertension-100611095",false,"NCT07236125","Dietary Nitrate and the Oral Microbiome in Children With Primary Hypertension","Investigation of the Relationship Between Dietary Nitrate and Oral Microbiota in Children With Primary Hypertension","Inclusion Criteria:\n\n* Applied to the Istanbul University Faculty of Medicine, Department of Pediatric Nephrology,\n* Between the ages of 10 and 18,\n* Diagnosed with primary hypertension,\n* Clinically excluded from secondary hypertension or heart failure,\n* No systemic or chronic disease other than hypertension,\n* No periodontal disease, dental infection, or oral mucosal disease,\n* Not taking regular antihypertensive or other medications for a chronic disease,\n* Not having received antibiotic treatment in the last 3 months,\n* Patients who have not used mouthwash in the last 3 months,\n* Have no allergies to nitrate-rich foods,\n* Both male and female patients will be included.\n\nExclusion Criteria:\n\n* Younger than 10 years of age or older than 18 years of age\n* Clinically diagnosed with secondary hypertension or heart failure\n* Have a systemic disease\n* Have periodontal disease, dental infection, or oral mucosal disease\n* Are taking regular antihypertensive medications or other chronic illnesses\n* Have received antibiotic treatment within the last 3 months\n* Have used mouthwash within the last 3 months\n* Are allergic to nitrate-rich foods will not be included in the study.",true,"ALL","10 Years","18 Years",{"count":66,"type":67},48,"ESTIMATED","1 Day","OBSERVATIONAL","Children and adolescents with primary hypertension (high blood pressure without an underlying secondary cause) are at increased risk of cardiovascular disease in adulthood. Recent research suggests that not only the heart and blood vessels, but also the bacteria living in the mouth may play a role in blood pressure regulation. Certain oral bacteria can convert nitrate from food into nitrite and then into nitric oxide, a substance that helps blood vessels relax. If this nitrate-nitrite-nitric oxide pathway is impaired, blood pressure may rise.\n\nThis study aims to investigate the relationship between oral microbiota, salivary nitric oxide reductase activity and blood pressure in children and adolescents with primary hypertension compared with healthy peers. We will recruit participants aged 10-18 years who have a diagnosis of primary hypertension and an age- and sex-matched control group without hypertension.\n\nAll participants will undergo a non-invasive oral and dental examination and standardized blood pressure measurements. Saliva samples will be collected to measure pH, flow rate, nitrate and nitrite levels, total protein, lysozyme activity and to analyze the composition of oral bacteria using modern DNA-based techniques. Participants and\u002For their parents will also complete brief questionnaires about diet and general health.\n\nNo medication or dietary supplement will be given as part of the study, and no additional blood samples will be taken beyond routine clinical care. The main risk is minimal discomfort related to oral examination and saliva collection. There is no guaranteed direct benefit for participants; however, the results may help us better understand how oral bacteria and salivary nitric oxide pathways are linked to high blood pressure in young people. This knowledge may support the development of new non-invasive strategies for early detection and prevention of hypertension in the future.",[72],"Primary Hypertension",[74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"primary hypertension","oral microbiome","nitrate-reduction bacteria","salivary nitrite","salivary nitrate","pediatric hypertension","Enterosalivary Nitrate Cycle","Adolescent Hypertension","Salivary Microbiome","Nitrate-Nitrite-Nitric Oxide Pathway","Saliva Biomarkers","Endothelial Dysfunction","Blood Pressure in Adolescents","Non-invasive Biomarkers","Saliva-Based Diagnostics","2026-05-04",{"date":91,"type":92},"2026-05-08","ACTUAL",{"date":94,"type":92},"2026-04-15",{"date":96,"type":67},"2027-01-15",{"name":48,"class":6},1]