Dental CariesPhase 4IncipientNCT06172764
A Randomized Controlled Trial of Vitamin D Supplementation on Salivary Biomarkers and Cariogenic Oral Microbiome
A Phase 4 study testing Vitamin D supplements along with behavioral modification, Topical fluoride application and Vitamin D supplements along with behavioral modification and Topical fluoride application along with behavioral modification in people with Dental Caries and White Spot Lesion, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, White Spot Lesion, Initial Caries
- What is being tested?
- Vitamin D supplements along with behavioral modification, Topical fluoride application and Vitamin D supplements along with behavioral modification and Topical fluoride application along with behavioral modification
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Dec 2023to Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Dr Saba Arshad
Karachi, Sindh, 75330
Dr Saba Arshad, saba.arshad@duhs.edu.pk
About this study
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
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.
Read the 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).
- 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
- Keywords
- Dental Caries, White Spot Lesion, Initial Caries, Incipient Enamel Caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplements along with behavioral modificationDietary supplement
Vitamin D soft gel capsules of 50,000 IU/week for two months followed by a maintenance dosage of 5000 IU/day for one month.
Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling.
Topical fluoride application and Vitamin D supplements along with behavioral modificationCombination product
Professional topical 5% sodium fluoride gel application for 5 minutes on the teeth having ICL.
Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling.
Vitamin D soft gel capsules of 50,000 IU/week for two months followed by a maintenance dosage of 5000 IU/day for one month.
Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling.
Topical fluoride application along with behavioral modificationProcedure or surgery
Professional topical 5% sodium fluoride gel application for 5 minutes on the teeth having ICL.
Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling.
Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | vitamin D Deficient group having initial caries Receives: Dietary Supplement: Vitamin D supplements along with behavioral modification |
| Group B | Active comparator | vitamin D deficient group having initial caries Receives: Combination Product: Topical fluoride application and Vitamin D supplements along with behavioral modification |
| Group C | Placebo comparator | vitamin D sufficient group having initial caries Receives: Procedure: Topical fluoride application along with behavioral modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICDAS scores of initial caries or white spot lesions
Change in ICDAS scores of initial caries or white spot lesions
Measured: 6 months
Number of growth forming units of microbial strains
Change in number of growth forming units of microbial strains
Measured: 6 months
Genetic expression of target genes of S. Mutans and L. Rhamnosus
Presence or absence of genetic expression of target genes of S. Mutans and L. Rhamnosus
Measured: 6 months
Secondary outcomes (2)
Serum Vitamin D levels
Change in Serum Vitamin D levels
Measured: 6 months
Salivary protein concentration
Change in salivary protein concentration
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start12 Dec 2023
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Karachi
- Responsible party
- Principal investigator, Saba Arshad, Dow University of Health Sciences
- Investigators
- Dr Saba Arshad, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172764
- Sponsor's protocol ID
- SArshad
- Acronym
- Incipient
- Status last verified
- Mar 2025
- First submitted
- 12 Dec 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06172764
- Acronym / sponsor ID
- Incipient / SArshad
- Keywords
- Dental Caries, White Spot Lesion, Initial Caries, Incipient Enamel Caries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Collaborators
- University of Karachi
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: Vitamin D supplements along with behavioral modificationvitamin D Deficient group having initial caries |
| Group B | Active comparator | Combination Product: Topical fluoride application and Vitamin D supplements along with behavioral modificationvitamin D deficient group having initial caries |
| Group C | Placebo comparator | Procedure: Topical fluoride application along with behavioral modificationvitamin D sufficient group having initial caries |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D supplements along with behavioral modificationVitamin D soft gel capsules of 50,000 IU/week for two months followed by a maintenance dosage of 5000 IU/day for one month. Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling. | Dietary supplement | Group A |
| Topical fluoride application and Vitamin D supplements along with behavioral modificationProfessional topical 5% sodium fluoride gel application for 5 minutes on the teeth having ICL. Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling. Vitamin D soft gel capsules of 50,000 IU/week for two months followed by a maintenance dosage of 5000 IU/day for one month. Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling. | Combination product | Group B |
| Topical fluoride application along with behavioral modificationProfessional topical 5% sodium fluoride gel application for 5 minutes on the teeth having ICL. Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling. Behavior modification for dental caries with standard instructions of brushing teeth twice daily with regular fluoridated toothpaste and diet counseling. | Procedure or surgery | Group C |
Primary outcome
ICDAS scores of initial caries or white spot lesions
Time frame: 6 months
Change in ICDAS scores of initial caries or white spot lesions
Number of growth forming units of microbial strains
Time frame: 6 months
Change in number of growth forming units of microbial strains
Genetic expression of target genes of S. Mutans and L. Rhamnosus
Time frame: 6 months
Presence or absence of genetic expression of target genes of S. Mutans and L. Rhamnosus
2 secondary outcomes
Serum Vitamin D levels
Time frame: 6 months
Salivary protein concentration
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Saba Arshad principal investigator
DUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D supplements along with behavioral modification, Topical fluoride application and Vitamin D supplements along with behavioral modification and Topical fluoride application along with behavioral modification in people with Dental Caries and White Spot Lesion, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Saba Arshad (02138771111, saba.arshad@duhs.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICDAS scores of initial caries or white spot lesions (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.