[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"incipient-enamel-caries\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:incipient-enamel-caries":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":33,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"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":22,"type":23},90,"ESTIMATED","INTERVENTIONAL",[26],"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.",[29,30,31,32],"Dental Caries","White Spot Lesion","Initial Caries","Incipient Enamel Caries",[29,30,31,32],"RECRUITING","2025-03-08",{"date":37,"type":38},"2025-03-11","ACTUAL",{"date":40,"type":38},"2023-12-12",{"date":42,"type":23},"2025-12",{"name":44,"class":45},"Dow University of Health Sciences","OTHER"]