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

NCT ID: NCT06172764

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-12
• Study Completion Date: 2025-12-31

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.

Detailed Description

The study investigator will conduct a multi-centered randomized clinical trial in the outpatient department of Operative Dentistry, in three units of Dow University of Health Sciences (DUHS), with parallel treatment assignment to an experimental, active comparator, and control groups. The investigator will recruit study participants aged 12 to 45 at moderate risk of dental caries, specifically those with vitamin D deficiency. Additionally, participants must have at least two clinically diagnosed teeth with initial carious lesions (ICL). Each participant will be enrolled for six months in this trial.

The investigator will obtain data on vitamin D deficiency from Dow Diagnostic Laboratory. Dental caries risk will be assessed using a caries risk assessment (CRA) form, while ICL will be evaluated through the International Caries Detection and Assessment System (ICDAS) scores. The investigator will collect the samples of participants' saliva to analyze salivary proteins using the enzyme-linked immunosorbent assay (ELISA), and cariogenic microbes through polymerase chain reaction (PCR).

Participants will be assigned to one of three groups randomly:

• Group A participants will be vitamin D deficient with caries, receiving vitamin D supplements and Oral hygiene instructions (OHI).
• Group B participants will be vitamin D deficient with caries, receiving vitamin D supplements, topical fluorides, and OHI.
• Group C participants will be vitamin D sufficient to be considered as controls for comparison, receiving fluoride application and OHI.

The investigator will assess study outcomes by observing changes in ICDAS scores, salivary protein concentrations, and count of cariogenic bacterial species (Streptococcal mutans and Lactobacilli).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

vitamin D Deficient group having initial caries

Group Type: EXPERIMENTAL

Vitamin D supplements along with behavioral modification

Intervention Type: 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 B

vitamin D deficient group having initial caries

Group Type: ACTIVE_COMPARATOR

Topical fluoride application and Vitamin D supplements along with behavioral modification

Intervention Type: 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 C

vitamin D sufficient group having initial caries

Group Type: PLACEBO_COMPARATOR

Topical fluoride application along with behavioral modification

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: COMBINATION_PRODUCT

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Karachi

OTHER

Sponsor Role: collaborator

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Saba Arshad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Saba Arshad

Role: PRINCIPAL_INVESTIGATOR

DUHS

Locations

Dr Saba Arshad

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Dr Saba Arshad

Role: CONTACT

saba.arshad@duhs.edu.pk

02138771111

Dr. Sadiah Muhammad Saleem Ullah Khan

Role: CONTACT

sadiah.saleem@uok.edu.pk

02199261300

Facility Contacts

Dr Saba Arshad

Role: primary

saba.arshad@duhs.edu.pk

Other Identifiers

SArshad

Identifier Type: -

Identifier Source: org_study_id