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

ConditionsDental CariesWhite Spot LesionInitial CariesIncipient Enamel Caries
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12-50
SponsorDow University of Health Sciences

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin D supplements along with behavioral modification

    Dietary supplement

    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.

  • Topical fluoride application and Vitamin D supplements along with behavioral modification

    Combination product

    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.

  • Topical fluoride application along with behavioral modification

    Procedure/Surgery

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention
Group C: Group CPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

ICDAS scores of initial caries or white spot lesions

Change in ICDAS scores of initial caries or white spot lesions

Time frame
6 months
2

Number of growth forming units of microbial strains

Change in number of growth forming units of microbial strains

Time frame
6 months
3

Genetic expression of target genes of S. Mutans and L. Rhamnosus

Presence or absence of genetic expression of target genes of S. Mutans and L. Rhamnosus

Time frame
6 months

Secondary outcomes

1

Serum Vitamin D levels

Change in Serum Vitamin D levels

Time frame
6 months
2

Salivary protein concentration

Change in salivary protein concentration

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dow University of Health Sciences

Lead sponsor

University of Karachi

Collaborator

Source ClinicalTrials.gov
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