Actively Recruiting
Effect of Vitamin D Supplementation on Salivary Biomarkers and Cariogenic Oral Microbiome for Dental Caries Management: A Randomized Controlled Trial
Led by Dow University of Health Sciences · Updated on 2025-03-11
90
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
D
Dow University of Health Sciences
Lead Sponsor
U
University of Karachi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of vitamin D supplementation and topical fluoride treatments on people aged 12 to 45 who have vitamin D deficiency and early dental cavities called Initial Carious Lesions (ICL). This trial aims to compare how these treatments influence the progression of ICL by measuring changes in the International Caries Detection and Assessment System (ICDAS) scores, concentrations of proteins in saliva, and the presence of cavity-causing bacteria over six months. The study is conducted as a randomized controlled trial at multiple outpatient centers. Participants are randomly assigned to one of three groups: Group A receives vitamin D supplements and oral hygiene instructions; Group B receives vitamin D supplements, topical fluoride application, and oral hygiene instructions; and Group C, the control group with sufficient vitamin D levels, receives topical fluoride and oral hygiene instructions. Vitamin D supplements include weekly 50,000 IU doses for two months followed by daily maintenance doses of 5,000 IU for one month. Fluoride treatments involve professional application of 5% sodium fluoride gel for five minutes on affected teeth. During the six-month study, participants will have their dental health monitored through assessments of their ICDAS scores, saliva samples analyzed for protein levels using ELISA, and bacterial counts measured by PCR techniques. Researchers will also check serum vitamin D levels. Oral hygiene and diet counseling are provided. The study evaluates the progression of initial cavities, changes in saliva biomarkers, and oral bacteria to understand how these interventions impact dental caries management.
CONDITIONS
Brief Title
A Randomized Controlled Trial of Vitamin D Supplementation on Salivary Biomarkers and Cariogenic Oral Microbiome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 to 50 years of any gender
- Must have at least two teeth with clinically diagnosed Initial Carious Lesions
- Must be at moderate risk of dental caries
- Must have vitamin D deficiency
- Must provide written informed consent
You will not qualify if you...
- Presence of heavy calculus, gingivitis, or periodontitis
- Use of desensitizing toothpaste or mouthwash within six weeks before the study
- Severe intestinal or kidney disease, malabsorption syndrome, or other conditions affecting vitamin D metabolism
- Use of antibiotics or probiotics therapy within the last month
- Pregnant females
- Poor oral hygiene or excessive dietary exposure to acids and carbohydrates
- Patients without vitamin D deficiency or without initial carious lesions as required for study groups (implied by study design but not explicitly listed in exclusion criteria, so not included here as per instructions). Note: Only explicit exclusions are listed here as per source instructions and do not include inferred criteria beyond the source text.
Note: The last bullet is not added since it is implied eligibility rather than exclusion and not explicitly stated in exclusion criteria.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive assigned interventions including vitamin D supplements, topical fluoride applications, and behavioral modifications depending on group assignment to manage dental caries.
Regular visits for treatment and assessments during the 6-month period
Trial Site Locations
Total: 1 location
1
Dr Saba Arshad
Karachi, Sindh, Pakistan, 75330
Actively Recruiting
Research Team
D
Dr Saba Arshad
D
Dr. Sadiah Muhammad Saleem Ullah Khan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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