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

Dental Caries Clinical Trial

— Incipient  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172764
• Other study ID #: SArshad
• Status: Recruiting
• Phase: Phase 4
• Start date: December 12, 2023
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: Dow University of Health Sciences
• Contact: Dr Saba Arshad
• Phone: 02138771111
• Email: saba.arshad[@]duhs.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Incipient Enamel Caries
• White Spot Lesion

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Dr Saba Arshad	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Dow University of Health Sciences	University of Karachi

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICDAS scores of initial caries or white spot lesions	Change in ICDAS scores of initial caries or white spot lesions	6 months
Primary	Number of growth forming units of microbial strains	Change in number of growth forming units of microbial strains	6 months
Primary	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	Serum Vitamin D levels	Change in Serum Vitamin D levels	6 months
Secondary	Salivary protein concentration	Change in salivary protein concentration	6 months