drugset / Trial / NCT06172764

A Randomized Controlled Trial of Vitamin D Supplementation on Salivary Biomarkers and Cariogenic Oral Microbiome

NCT06172764

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-12-12
Primary completion
2025-10
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Vitamin D Other / unclassified 5000 iu Oral
Subject sodium fluoride Unknown 5 % Topical

Indications