IncipientEffect of Vitamin D Supplementation on Salivary Biomarkers; Certain Proteins and Cariogenic Oral Microbiome for Medical Management of Dental Caries: A Randomized Controlled Trial
Vitamin D supplements along with behavioral modification
+ Topical fluoride application and Vitamin D supplements along with behavioral modification
+ Topical fluoride application along with behavioral modification
Dental Caries+1
+ Stomatognathic Diseases
+ Tooth Diseases
Treatment Study
Summary
Study start date: December 12, 2023
Actual date on which the first participant was enrolled.This study explores the impact of vitamin D supplementation on dental health, particularly focusing on salivary proteins and bacteria that cause tooth decay. The research targets individuals aged 12 to 45 who are at moderate risk for dental cavities and have a deficiency in vitamin D. Participants must also have at least two teeth with early signs of cavities. The goal is to understand if supplementing vitamin D can help manage dental caries by influencing the proteins in saliva and reducing harmful oral bacteria. This is important because improving vitamin D levels might offer a new way to prevent or manage dental cavities, which are a common health issue. Participants are randomly divided into three groups for a six-month period. Group A gets vitamin D supplements and oral hygiene advice; Group B receives vitamin D supplements, fluoride treatments, and oral hygiene advice; and Group C, the control group, receives fluoride treatments and oral hygiene advice without vitamin D supplements. The study evaluates changes in cavity severity, levels of certain proteins in saliva, and the number of cavity-causing bacteria. These results help determine whether vitamin D supplements can positively affect dental health and reduce the risk of cavities.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorGroup III
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location