A Randomized Controlled Trial of Vitamin D Supplementation on Salivary Biomarkers and Cariogenic … (NCT06172764) | Clinical Trial Compass
RecruitingPhase 4
A Randomized Controlled Trial of Vitamin D Supplementation on Salivary Biomarkers and Cariogenic Oral Microbiome
Pakistan90 participantsStarted 2023-12-12
Plain-language summary
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.
Who can participate
Age range
12 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ICDAS scores of initial caries or white spot lesions
Timeframe: 6 months
2
Number of growth forming units of microbial strains
Timeframe: 6 months
3
Genetic expression of target genes of S. Mutans and L. Rhamnosus