Viewing Study NCT06172764



Ignite Creation Date: 2024-05-06 @ 7:54 PM
Last Modification Date: 2024-10-26 @ 3:16 PM
Study NCT ID: NCT06172764
Status: RECRUITING
Last Update Posted: 2023-12-26
First Post: 2023-12-12

Brief Title: A Randomized Controlled Trial of Vitamin D Supplementation on Salivary Biomarkers and Cariogenic Oral Microbiome
Sponsor: Dow University of Health Sciences
Organization: Dow University of Health Sciences

Study Overview

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
Status: RECRUITING
Status Verified Date: 2023-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Incipient
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None