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A Randomized Controlled Trial of Vitamin D Supplementation on Salivary Biomarkers and Cariogenic Oral Microbiome

RecruitingPhase 4Ages 12 Years - 50 YearsAllDow University of Health Sciences
NCT06172764 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. * Group A will get vitamin D supplements and oral hygiene instructions (OHI). * Group B will get vitamin D supplements, topical fluorides, and OHI. * Group C (Control), the vitamin D sufficient group will get topical fluorides and OHI.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. * Patients having vitamin D deficiency. Exclusion Criteria: * Patients who have heavy calculus, gingivitis, or periodontitis. * Patients using desensitizing toothpaste or mouthwash up to six weeks before the study. * Patients who have severe intestine or kidney disease, malabsorption syndrome, or any other conditions affecting vitamin D metabolism. * Patients on antibiotics or probiotics therapy for the last month * Pregnant females. * Patients with poor oral hygiene and with excessive dietary exposure to acids and carbohydrates.
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What it tests

  • Vitamin D supplements along with behavioral modification
  • Topical fluoride application and Vitamin D supplements along with behavioral modification
  • Topical fluoride application along with behavioral modification
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Where

1 site
Dr Saba Arshad
Karachi, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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