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

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Procedure, Dietary supplement
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 50
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Pakistan
Dr Saba Arshad
RECRUITING
Karachi
Contact Information
Primary
Dr Saba Arshad
saba.arshad@duhs.edu.pk
02138771111
Backup
Dr. Sadiah Muhammad Saleem Ullah Khan
sadiah.saleem@uok.edu.pk
02199261300
Time Frame
Start Date: 2023-12-12
Estimated Completion Date: 2025-12
Participants
Target number of participants: 90
Treatments
Experimental: Group A
vitamin D Deficient group having initial caries
Active_comparator: Group B
vitamin D deficient group having initial caries
Placebo_comparator: Group C
vitamin D sufficient group having initial caries
Related Therapeutic Areas
Sponsors
Leads: Dow University of Health Sciences
Collaborators: University of Karachi

This content was sourced from clinicaltrials.gov