Recruiting PHASE4 Dental Caries

New treatment option for Dental Caries

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

ClinicalTrials.gov ID: NCT06172764

What this study is testing

What is Topical fluoride application and Vitamin D supplements along with behavioral modification?

Topical fluoride application and Vitamin D supplements along with behavioral modification is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for dental caries.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 12 to 50. Healthy volunteers may be eligible.

You may be able to join if

  • Patients of all genders and ages ranging from 12-50 years, having at least two teeth with clinically diagnosed Initial Carious Lesions at Moderate...
  • Patients having vitamin D deficiency.

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Karachi, Sindh, Pakistan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 12 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Karachi, Sindh, Pakistan. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.