[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529360":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":43,"centralContacts":48,"locations":57,"responsibleParty":73,"collaborators":76,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":32,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":103,"overallStatus":59,"whyStopped":32,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Dow University of Health Sciences","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","vitamin D Deficient group having initial caries",[13],"Dietary Supplement: Vitamin D supplements along with behavioral modification",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B","ACTIVE_COMPARATOR","vitamin D deficient group having initial caries",[19],"Combination Product: Topical fluoride application and Vitamin D supplements along with behavioral modification",{"label":21,"type":22,"description":23,"interventionNames":24},"Group C","PLACEBO_COMPARATOR","vitamin D sufficient group having initial caries",[25],"Procedure: Topical fluoride application along with behavioral modification",[27,33,38],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","Vitamin D supplements along with behavioral modification","Vitamin D soft gel capsules of 50,000 IU\u002Fweek for two months followed by a maintenance dosage of 5000 IU\u002Fday for one month.\n\nBehavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling.",[9],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"COMBINATION_PRODUCT","Topical fluoride application and Vitamin D supplements along with behavioral modification","Professional topical 5% sodium fluoride gel application for 5 minutes on the teeth having ICL.\n\nBehavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling.\n\nVitamin D soft gel capsules of 50,000 IU\u002Fweek for two months followed by a maintenance dosage of 5000 IU\u002Fday for one month.\n\nBehavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling.",[15],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":32},"PROCEDURE","Topical fluoride application along with behavioral modification","Professional topical 5% sodium fluoride gel application for 5 minutes on the teeth having ICL.\n\nBehavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling.\n\nBehavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling.",[21],[44],{"name":45,"affiliation":46,"role":47},"Dr Saba Arshad","DUHS","PRINCIPAL_INVESTIGATOR",[49,53],{"name":45,"role":50,"phone":51,"phoneExt":32,"email":52},"CONTACT","02138771111","saba.arshad@duhs.edu.pk",{"name":54,"role":50,"phone":55,"phoneExt":32,"email":56},"Dr. Sadiah Muhammad Saleem Ullah Khan","02199261300","sadiah.saleem@uok.edu.pk",[58],{"facility":45,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Karachi","Sindh","75330","Pakistan","PK",{"type":66,"coordinates":67},"Point",[68,69],67.0104,24.8608,{"lat":69,"lon":68},[72],{"name":45,"role":50,"phone":32,"phoneExt":32,"email":52},{"type":47,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Saba Arshad","Principal Investigator",[77],{"name":78,"class":6},"University of Karachi","100529360","phase-4-a-randomized-controlled-trial-of-vitamin-d-supplementation-on-salivary-biomarkers-and-cariogenic-oral-microbiome-100529360",false,"NCT06172764","A Randomized Controlled Trial of Vitamin D Supplementation on Salivary Biomarkers and Cariogenic Oral Microbiome","Effect of Vitamin D Supplementation on Salivary Biomarkers; Certain Proteins and Cariogenic Oral Microbiome for Medical Management of Dental Caries: A Randomized Controlled Trial","Incipient","Inclusion Criteria:\n\n* Patients of all genders and ages ranging from 12-50 years, having at least two teeth with clinically diagnosed Initial Carious Lesions at Moderate Risk of Dental Caries, after written informed consent.\n* Patients having vitamin D deficiency.\n\nExclusion Criteria:\n\n* Patients who have heavy calculus, gingivitis, or periodontitis.\n* Patients using desensitizing toothpaste or mouthwash up to six weeks before the study.\n* Patients who have severe intestine or kidney disease, malabsorption syndrome, or any other conditions affecting vitamin D metabolism.\n* Patients on antibiotics or probiotics therapy for the last month\n* Pregnant females.\n* Patients with poor oral hygiene and with excessive dietary exposure to acids and carbohydrates.",true,"ALL","12 Years","50 Years",{"count":92,"type":93},90,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","The goal of this clinical trial is to compare the treatment effect of vitamin D supplementation and topical fluorides in the population having vitamin D deficiency and Initial Carious Lesions (ICL) on the progression of ICL in teeth. This study aims to observe the changes in the International Caries Detection and Assessment System (ICDAS) scores, the concentration of salivary proteins, and cariogenic microbes, six months after the interventions.\n\n* Group A will get vitamin D supplements and oral hygiene instructions (OHI).\n* Group B will get vitamin D supplements, topical fluorides, and OHI.\n* Group C (Control), the vitamin D sufficient group will get topical fluorides and OHI.",[99,100,101,102],"Dental Caries","White Spot Lesion","Initial Caries","Incipient Enamel Caries",[99,100,101,102],"2025-03-08",{"date":106,"type":107},"2025-03-11","ACTUAL",{"date":109,"type":107},"2023-12-12",{"date":111,"type":93},"2025-12",{"name":5,"class":6},1]