RecruitingPhase 4NCT06172764

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

Effect of Vitamin D Supplementation on Salivary Biomarkers; Certain Proteins and Cariogenic Oral Microbiome for Medical Management of Dental Caries: A Randomized Controlled Trial

Sponsor

Dow University of Health Sciences

Enrollment

90 participants

Start Date

Dec 12, 2023

Study Type

INTERVENTIONAL

Conditions

Dental Caries White Spot Lesion Initial Caries Incipient Enamel Caries

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.

Eligibility

Min Age: 12 YearsMax Age: 50 Years

Inclusion Criteria2

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 Criteria6

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.

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Interventions

DIETARY_SUPPLEMENTVitamin 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_PRODUCTTopical 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.

PROCEDURETopical 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.