Actively Recruiting
A Randomized Controlled Trial of Vitamin D Supplementation on Salivary Biomarkers and Cariogenic Oral Microbiome
Led by Dow University of Health Sciences · Updated on 2025-03-11
90
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
D
Dow University of Health Sciences
Lead Sponsor
U
University of Karachi
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Randomized Controlled Trial of Vitamin D Supplementation on Salivary Biomarkers and Cariogenic Oral Microbiome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of all genders aged 12 to 50 years
- At least two teeth with clinically diagnosed Initial Carious Lesions
- Moderate risk of dental caries
- Vitamin D deficiency
- Written informed consent provided
You will not qualify if you...
- Heavy calculus, gingivitis, or periodontitis
- Use of desensitizing toothpaste or mouthwash within six weeks before the study
- Severe intestine or kidney disease, malabsorption syndrome, or other conditions affecting vitamin D metabolism
- Antibiotics or probiotics therapy within the last month
- Pregnant females
- Poor oral hygiene
- Excessive dietary exposure to acids and carbohydrates
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dr Saba Arshad
Karachi, Sindh, Pakistan, 75330
Actively Recruiting
Research Team
D
Dr Saba Arshad
CONTACT
D
Dr. Sadiah Muhammad Saleem Ullah Khan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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