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

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What is being tested

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

Dietary SupplementCombination ProductProcedure
Who is being recruted

Dental Caries+1

+ Stomatognathic Diseases

+ Tooth Diseases

From 12 to 50 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: December 2023
See protocol details

Summary

Principal SponsorDow University of Health Sciences
Study ContactDr Saba ArshadMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleEffect of Vitamin D Supplementation on Salivary Biomarkers; Certain Proteins and Cariogenic Oral Microbiome for Medical Management of Dental Caries: A Randomized Controlled Trial
Principal SponsorDow University of Health Sciences
Study ContactDr Saba ArshadMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Dental CariesStomatognathic DiseasesTooth DiseasesTooth Demineralization

Criteria

2 inclusion criteria required to participate
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.

6 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
vitamin D Deficient group having initial caries

Group II

Active Comparator
vitamin D deficient group having initial caries

Group III

Placebo
vitamin D sufficient group having initial caries

Study 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

Recruiting

Dr Saba Arshad

Karachi, PakistanOpen Dr Saba Arshad in Google Maps
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One Study Center