Clinical Trial

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

Study acronym: Incipient
Recruiting Phase 4
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Record status
This record was last updated March 11, 2025 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-12-12; most recent amendment 2025-03-08.
Trial Details
NCT Number NCT06172764
Lead Sponsor Dow University of Health Sciences
Collaborators: University of Karachi
Conditions Dental Caries, White Spot Lesion, Initial Caries, Incipient Enamel Caries
Enrollment 90 participants
Start Date 2023-12-12
Primary Completion 2025-10 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-03-11