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Search / Trial NCT06172764

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

Launched by DOW UNIVERSITY OF HEALTH SCIENCES · Dec 12, 2023

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Dental Caries White Spot Lesion Initial Caries Incipient Enamel Caries

ClinConnect Summary

This clinical trial is studying how vitamin D supplements can help improve dental health, specifically in people who have early signs of tooth decay known as Initial Carious Lesions. Researchers want to see if vitamin D can prevent these lesions from getting worse compared to using fluoride treatments. Participants will be divided into three groups: one group will receive vitamin D supplements and tips on oral hygiene; another group will get both vitamin D and fluoride treatments along with hygiene tips; and the last group, who already have enough vitamin D, will only receive fluoride and hygiene tips. The study will last for six months, during which researchers will monitor changes in tooth health and the types of bacteria present in saliva.

To be eligible for the trial, participants should be between 12 and 50 years old, have at least two teeth with early signs of decay, and have a vitamin D deficiency. Some individuals may not qualify, including those with certain gum diseases, severe health issues affecting vitamin D, or those currently using specific dental products. This study is actively recruiting participants, and it aims to provide insights into how vitamin D might be an effective way to support dental health in those at risk of decay.

Gender

ALL

Eligibility criteria

  • 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.

About Dow University Of Health Sciences

Dow University of Health Sciences (DUHS) is a premier educational and research institution based in Karachi, Pakistan, dedicated to advancing healthcare through innovative research and clinical excellence. As a clinical trial sponsor, DUHS integrates cutting-edge scientific inquiry with practical applications, fostering a collaborative environment that promotes the development of new treatments and therapies. The institution is committed to upholding the highest ethical standards in research, ensuring participant safety, and contributing to the global body of medical knowledge. With a focus on interdisciplinary collaboration and community health impact, DUHS plays a pivotal role in enhancing the quality of healthcare both locally and internationally.

Locations

Karachi, Sindh, Pakistan

Patients applied

0 patients applied

Trial Officials

Dr Saba Arshad

Principal Investigator

DUHS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported