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 range12 Years – 50 Years

SexALL

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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.

What they're measuring

ICDAS scores of initial caries or white spot lesions

Timeframe: 6 months

Number of growth forming units of microbial strains

Timeframe: 6 months

Genetic expression of target genes of S. Mutans and L. Rhamnosus

Timeframe: 6 months

Trial details

NCT IDNCT06172764

SponsorDow University of Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10

Contact for this trial

Dr Saba Arshad

02138771111 saba.arshad@duhs.edu.pk

View on ClinicalTrials.gov More Dental Caries trials

Plain-language summary

Who can participate

Age range12 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.