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| Name | Class |
|---|---|
| University of Karachi | OTHER |
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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | vitamin D Deficient group having initial caries |
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| Group B | Active Comparator | vitamin D deficient group having initial caries |
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| Group C | Placebo Comparator | vitamin D sufficient group having initial caries |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D supplements along with behavioral modification | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ICDAS scores of initial caries or white spot lesions | Change in ICDAS scores of initial caries or white spot lesions | 6 months |
| Number of growth forming units of microbial strains | Change in number of growth forming units of microbial strains | 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Vitamin D levels | Change in Serum Vitamin D levels | 6 months |
| Salivary protein concentration | Change in salivary protein concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Saba Arshad | Contact | 02138771111 | saba.arshad@duhs.edu.pk | |
| Dr. Sadiah Muhammad Saleem Ullah Khan | Contact | 02199261300 | sadiah.saleem@uok.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| Dr Saba Arshad | DUHS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Saba Arshad | Recruiting | Karachi | Sindh | 75330 | Pakistan |
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| Topical fluoride application and Vitamin D supplements along with behavioral modification | Combination 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 modification | Procedure | 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. |
|
| 6 months |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D000097182 | Fluoride Treatment |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D005457 | Fluoridation |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
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