Vitamin D supplementation for dental caries treatment
Effect of Vitamin D Supplementation on Salivary Biomarkers; Certain Proteins and Cariogenic Oral Microbiome for Medical Management of Dental Caries: A Randomized Controlled Trial
This study is testing whether vitamin D supplements can help people aged 12 to 45 with early tooth decay get better compared to those using fluoride treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 12 Years to 50 Years |
| Sex | All |
| Sponsor | Dow University of Health Sciences Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT06172764 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effects of vitamin D supplementation and topical fluorides on the progression of initial carious lesions in individuals with vitamin D deficiency. Participants aged 12 to 45 with at least two clinically diagnosed initial carious lesions will be randomly assigned to one of three groups: one receiving vitamin D and oral hygiene instructions, another receiving vitamin D, topical fluorides, and oral hygiene instructions, and a control group receiving topical fluorides and oral hygiene instructions. The study will assess changes in caries detection scores, salivary protein concentrations, and cariogenic microbes over a six-month period. Data will be collected through clinical assessments and laboratory analyses.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 to 45 with vitamin D deficiency and at least two initial carious lesions.
Not a fit: Patients with severe oral health issues, such as periodontitis or those on certain medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new approach to preventing dental caries in patients with vitamin D deficiency.
How similar studies have performed: Other studies have shown promising results with vitamin D supplementation in oral health, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Karachi, Sindh
- Dr Saba Arshad — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Principal investigator: Dr Saba Arshad — Duhs
- Study coordinator: Dr Saba Arshad
- Email: saba.arshad@duhs.edu.pk
- Phone: 02138771111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.