[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640997":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":43,"centralContacts":47,"locations":56,"responsibleParty":79,"collaborators":83,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":29,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":59,"whyStopped":29,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Alanya Alaaddin Keykubat University","OTHER",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"5% Sodium Fluoride (NaF) Varnish","EXPERIMENTAL","Caries-active children aged 6-8 years. Teeth are gently air-dried for 30 seconds under isolation with cotton rolls and aspirator. Approximately 0.5 mL of 5% NaF varnish is applied to all teeth sequentially by quadrant starting from the upper jaw using an applicator tip and left in place for 1 minute. Parents are instructed to restrict water and hard food intake for 1 hour post-application. Saliva samples collected at T0, T1 and T2. n=20.",[13],"Other: 5% Sodium Fluoride Varnish",{"label":15,"type":10,"description":16,"interventionNames":17},"2% Chlorhexidine Pre-Treatment + 5% NaF Varnish","Caries-active children aged 6-8 years. Teeth are gently air-dried for 30 seconds under isolation. 2% CHX is applied to the lesion\u002Ftooth surfaces using an applicator tip and left for 30 seconds. Excess CHX is absorbed, an additional 30 seconds was allowed to pass.NaF varnish was then applied and left for 1 minute. Precautions are taken to prevent CHX ingestion. Parents are instructed to restrict water and hard food intake for 1 hour post-application. Saliva samples collected at T0, T1 and T2. n=20.",[18],"Other: 2% Chlorhexidine Pre-Treatment + 5% NaF Varnish",{"label":20,"type":21,"description":22,"interventionNames":23},"Standard Care \u002F Oral Hygiene Education","ACTIVE_COMPARATOR","Caries-active children aged 6-8 years. No professional topical agent is applied. Children and parents receive standardized oral hygiene education including twice-daily brushing with fluoride toothpaste, reduction of sugar frequency, and a brief parent information brochure. Necessary treatment will be offered at the end of the study upon request (wait-list design). Saliva samples collected at T0 and T2. n=20.",[24],"Behavioral: Standard Oral Hygiene Education",{"label":26,"type":27,"description":28,"interventionNames":29},"Caries-Free Healthy Control","NO_INTERVENTION","Age- and sex-matched caries-free children (ICDAS II = 0, dmft = 0) aged 6-8 years. No intervention is applied. Clinical assessment (dmft\u002FICDAS) is performed and recorded. Saliva sampling is performed at T0 only. This group serves as a non-randomized biological reference group. n=20.",null,[31,35,38],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"5% Sodium Fluoride Varnish","Teeth are gently air-dried for 30 seconds under isolation with cotton rolls and aspirator. Approximately 0.5 mL of 5% NaF varnish is applied to all tooth surfaces sequentially by quadrant starting from the upper jaw using an applicator tip and left in place for 1 minute. Parents are instructed to restrict water and hard food intake for 1 hour post-application. This is a routine preventive application; no off-label use is involved.",[9],{"type":6,"name":15,"description":36,"armGroupLabels":37,"otherNames":29},"Following isolation and air-drying, 2% chlorhexidine solution is applied to the lesion\u002Ftooth surfaces using an applicator tip and left in place for 30 seconds. Excess CHX is then absorbed. Precautions are taken to prevent ingestion. This pre-treatment is performed immediately prior to 5% NaF varnish application. This is a routine preventive application; no off-label use is involved.",[15],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":29},"BEHAVIORAL","Standard Oral Hygiene Education","Children and parents receive standardized oral hygiene education including instruction on twice-daily brushing with fluoride toothpaste, reduction of sugar intake frequency, and a brief parent information brochure. No professional topical agent is applied. Necessary treatment will be offered at the end of the study upon request (wait-list design).",[20],[44],{"name":45,"affiliation":5,"role":46},"GÜL KESKİN, DDS, PhD","STUDY_DIRECTOR",[48,52],{"name":45,"role":49,"phone":50,"phoneExt":29,"email":51},"CONTACT","905444468857","gul.keskin@alanya.edu.tr",{"name":53,"role":49,"phone":54,"phoneExt":29,"email":55},"BİNNUR B ÖZDEMİR, DDS","905069033834","busra.ozdemir@alanya.edu.tr",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":29,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Alanya Alaaddin Keykubat University, Faculty of Dentistry","RECRUITING","Alanya","Antalya","07450","Turkey (Türkiye)",{"type":65,"coordinates":66},"Point",[67,68],31.99982,36.54375,{"lat":68,"lon":67},[71,72,73,75,77],{"name":45,"role":49,"phone":50,"phoneExt":29,"email":51},{"name":53,"role":49,"phone":54,"phoneExt":29,"email":55},{"name":45,"role":74,"phone":29,"phoneExt":29,"email":29},"PRINCIPAL_INVESTIGATOR",{"name":53,"role":76,"phone":29,"phoneExt":29,"email":29},"SUB_INVESTIGATOR",{"name":78,"role":76,"phone":29,"phoneExt":29,"email":29},"ERKAN MAYTALMAN, DDS, PhD",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"SPONSOR_INVESTIGATOR","Gül Keskin","Associate Professor Dr.",[84],{"name":5,"class":6},"100640997","the-effects-of-sodium-fluoride-and-chlorhexidine-use-on-salivary-il-6-and-matrix-metalloproteinase-levels-in-children-with-active-caries-100640997",false,"NCT07609797","The Effects of Sodium Fluoride and Chlorhexidine Use on Salivary IL-6 and Matrix Metalloproteinase Levels in Children With Active Caries","DentalCaries","Inclusion Criteria:\n\n* Children aged 6-8 years with all first permanent molars erupted\n* For active caries groups (Groups A, B, C): participants must meet at least one of the following criteria: dmft ≥ 6, or presence of at least one active caries lesion with an ICDAS code ≥ 3, or clinical evidence of active caries on ≥ 10 surfaces\n* For the dmft = 0 reference group (Group D): all surfaces caries-free and non-high-risk individuals (ICDAS II = 0); only baseline (T0) saliva sampling will be performed\n* No professional topical fluoride application or continuous CHX use within the past 3 months\n* No systemic chronic disease, immunodeficiency, or severe neuromotor disorder\n* No gingival redness, swelling, or bleeding\n* Written parental informed consent obtained\n\nExclusion Criteria:\n\n* Known allergy to fluoride compounds or varnish components\n* Behavioral problems that would prevent safe cooperation during application\n* Regular antibiotic use within the past 1 month\n* Individuals with infectious diseases\n* Those at high risk of endocarditis\n* History of substance dependence\n* Epilepsy\n* Renal failure or immunosuppression",true,"ALL","6 Years","8 Years",{"count":97,"type":98},80,"ESTIMATED","INTERVENTIONAL",[101],"NA","This study aims to compare salivary IL-6, MMP-8, MMP-9, and TIMP-1 levels between healthy children and caries-active children, and to evaluate the effects of 5% sodium fluoride (NaF) varnish and 2% chlorhexidine (CHX) used in caries prevention on these biomarkers.\n\nThe study will be conducted at Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Pediatric Dentistry. Informed consent will be obtained from children and their parents\u002Fguardians. Investigator calibration will be performed using Cohen's kappa method prior to data collection. Sample size was calculated assuming 80% power (1-β = 0.80), α = 0.05, and Cohen's d ≈ 0.8, resulting in 20 participants per group using G\\*Power 3.1 software.\n\nStudy groups: Group A: 5% NaF varnish. Group B: 2% CHX + 5% NaF varnish. Group C: Standard oral hygiene education (negative control). Group D: Caries-free children (biological reference; baseline saliva sampling only).\n\nSaliva samples will be collected at T0 (baseline), T1 (30 minutes post-application), and T2 (1 month). Unstimulated whole saliva will be collected, centrifuged at 5,000 g for 10 minutes at 4°C, and stored at -80°C. IL-6, MMP-8, MMP-9, and TIMP-1 levels will be measured using CE-marked\u002FFDA-approved human saliva ELISA kits.",[104,105],"Dental Caries","Dental Caries in Children",[107,108,109,110,111],"Dental caries","Matrix metalloproteinase","Interleukin-6","Sodium fluoride","Chlorhexidine","2026-06-01",{"date":114,"type":115},"2026-06-02","ACTUAL",{"date":117,"type":115},"2026-05-15",{"date":119,"type":98},"2027-06-30",{"name":81,"class":6},1]