Effect of Vitamin D Supplementation on Salivary Biomarkers; Certain Proteins and Cariogenic Oral Microbiome for Medical Management of Dental Caries: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Number of growth forming units of microbial strains
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of growth forming units of microbial strains
时间窗: 6 months
Change in number of growth forming units of microbial strains
ICDAS scores of initial caries or white spot lesions
时间窗: 6 months
Change in ICDAS scores of initial caries or white spot lesions
Genetic expression of target genes of S. Mutans and L. Rhamnosus
时间窗: 6 months
Presence or absence of genetic expression of target genes of S. Mutans and L. Rhamnosus
次要结局
- Serum Vitamin D levels(6 months)
- Salivary protein concentration(6 months)
研究者
Saba Arshad
Principal Investigator
Dow University of Health Sciences