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

Study acronym: Incipient
StatusRecruiting
PhasePhase 4
Started
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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.

Record History

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  1. Primary completion date: Dec 2024 to Oct 2025
    • Study completion date: Jun 2025 to Dec 2025
    v3
  2. Study description expanded, about 14 wordsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06172764
Lead Sponsor Dow University of Health Sciences
Collaborators: University of Karachi
Conditions
(from sponsor)		 Dental Caries, White Spot Lesion, Initial Caries, Incipient Enamel Caries
Related terms Dental Caries
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov