Evaluation of Vitamin D supplementation on salivary parameters, streptococcus mutans and lactobacillus counts in children: A Prospective Randomized Open Blinded End Point(PROBE)TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change in the counts of Streptococcus mutans and Lactobacillus in saliva.
研究概览
简要总结
According to the Global Burden of Disease Study in 2017, oral diseases affect approximately 3.5 billion people worldwide, with dental caries being the most common condition. In children, especially those aged 6 to 12 years, dental caries can cause pain, difficulty eating, and disrupted sleep, adversely affecting their overall quality of life and development. Therefore, there is a critical need for effective preventive and management strategies for dental caries in this age group.
Vitamin D is a fat-soluble vitamin primarily known for its role in calcium and phosphate homeostasis and bone health. However, recent research has highlighted its pleiotropic effects, particularly its influence on the immune system. The active form of Vitamin D, 1,25-dihydroxyvitamin D, has been shown to modulate both innate and adaptive immune responses, including the production of antimicrobial peptides such as cathelicidin and defensins, which help maintain the microbial balance of mucosal surfaces. In the context of oral health, Vitamin D may contribute to a reduction in cariogenic bacteria through several mechanisms. Firstly, it promotes the expression of antimicrobial peptides in salivary glands and oral epithelium. Secondly, it enhances the oral mucosa’s physical barrier function and immune surveillance, thereby limiting bacterial colonization. Thirdly, studies have reported an inverse relationship between serum Vitamin D levels and dental caries prevalence in children and adults.
This study proposes to assess the impact of daily supplementation of 1000 IU of Vitamin D3 for 7 days on the salivary counts of S. mutans and Lactobacillus in healthy individuals. The results may provide valuable insights into the antimicrobial potential of Vitamin D in oral health maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Children aged 6 to 12 years with or without dental caries.
- •2.Participants must be in good general health as determined by a medical history and physical examination.
- •3.Parents or guardians must provide written informed consent, and children must provide assent.
排除标准
- 未提供
结局指标
主要结局
The change in the counts of Streptococcus mutans and Lactobacillus in saliva.
时间窗: 1.Baseline | 2.1 hour after one vitamin D (1000IU) gummy consumption | 3.After 7 days of daily one vitamin D (1000IU) gummy consumption
次要结局
- 1. The change in the pH and buffering capacity of saliva.(2. The changes in salivary calcium and phosphorus levels)
研究者
Dr Dipanshu kumar
Department of Dentistry, AIIMS, Gorakhpur
