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

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.

Conditions

• Dental Caries
• White Spot Lesion
• Initial Caries
• Incipient Enamel Caries

Interventions

DIETARY_SUPPLEMENT

Vitamin D supplements along with behavioral modification

Vitamin D soft gel capsules of 50,000 IU/week for two months followed by a maintenance dosage of 5000 IU/day for one month. Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling.

COMBINATION_PRODUCT

Topical fluoride application and Vitamin D supplements along with behavioral modification

Professional topical 5% sodium fluoride gel application for 5 minutes on the teeth having ICL. Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling. Vitamin D soft gel capsules of 50,000 IU/week for two months followed by a maintenance dosage of 5000 IU/day for one month. Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling.

PROCEDURE

Topical fluoride application along with behavioral modification

Professional topical 5% sodium fluoride gel application for 5 minutes on the teeth having ICL. Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling. Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling.

Sponsors & Collaborators

• University of Karachi

  collaborator OTHER

• Dow University of Health Sciences

  lead OTHER

Principal Investigators

• Dr Saba Arshad · DUHS

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-12

Primary Completion

2025-10-31

Completion

2025-12-31

Countries

• Pakistan

Study Locations