A Randomized Controlled Trial of Vitamin D Supplementation on Salivary Biomarkers and Cariogenic Oral Microbiome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12-50
SponsorDow University of Health Sciences
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- 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
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Dow University of Health Sciences
Lead sponsor
University of Karachi
Collaborator
Source ClinicalTrials.gov