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

NCT06172764 | Recruiting Phase 4

• 1 other identifier: SArshad
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• ICDAS scores of initial caries or white spot lesions

  Change in ICDAS scores of initial caries or white spot lesions

  6 months

• Number of growth forming units of microbial strains

  Change in number of growth forming units of microbial strains

  6 months

• 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

  6 months

Secondary Outcomes (2)

• Serum Vitamin D levels

  6 months

• Salivary protein concentration

  6 months

Study Arms (3)

Group A

EXPERIMENTAL

vitamin D Deficient group having initial caries

Dietary Supplement: Vitamin D supplements along with behavioral modification

Group B

ACTIVE COMPARATOR

vitamin D deficient group having initial caries

Combination Product: Topical fluoride application and Vitamin D supplements along with behavioral modification

Group C

PLACEBO COMPARATOR

vitamin D sufficient group having initial caries

Procedure: Topical fluoride application along with behavioral modification

Interventions

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.

Group A

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.

Group B

Topical fluoride application along with behavioral modification PROCEDURE

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.

Group C

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead
• University of Karachi: collaborator

Study Sites (1)

Dr Saba Arshad

Karachi, Sindh, 75330, Pakistan

RECRUITING

MeSH Terms

Conditions

Dental Caries

Interventions

Behavior Therapy; Fluoride Treatment

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Fluoridation; Preventive Dentistry; Dentistry

Study Officials

• Dr Saba Arshad

  DUHS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Saba Arshad

CONTACT

02138771111; saba.arshad@duhs.edu.pk

Dr. Sadiah Muhammad Saleem Ullah Khan

CONTACT

02199261300; sadiah.saleem@uok.edu.pk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 15, 2023
• Study Start: December 12, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

PA (1)