Comparative evaluation of Probiotic Streptococcus salivarius K12 and M18 lozenges on salivary Streptococcus mutans and Lactobacillus counts in school going children: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 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 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.
Probiotics have emerged as a promising intervention for oral health, particularly in preventing and managing dental caries. Probiotics are live microorganisms that confer health benefits to the host when administered in adequate amounts. They work by modulating the oral microbiota, inhibiting the growth of pathogenic bacteria like S. mutans, and promoting a balanced microbial ecosystem. Among various probiotic strains, Streptococcus salivarius K12 has shown potential in reducing S. mutans levels and improving oral health. Additionally, combinations of multiple probiotic strains are being investigated for their synergistic effects on oral health.
This study aims to evaluate and compare the effects of Streptococcus salivarius K12 & M18 lozenges on the counts of S. mutans and Lactobacillus in the saliva of children aged 6 to 12 years. By understanding the efficacy of these probiotics, this research hopes to contribute to the development of effective strategies for the prevention and management of dental caries in school going children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 6 to 12 years with or without dental caries.
- •Participants must be in good general health as determined by a medical history and physical examination.
- •Parents or guardians must provide written informed consent, and children must provide assent.
排除标准
- •Children who have taken antibiotics or probiotics within the past 4 weeks.
- •Children with any chronic illness or condition that could affect oral health or saliva production Children with a history of allergies to probiotics or any components of the lozenges or gummies.
- •Children who are unable to comply with the study protocol, including regular attendance for follow-up visits.
- •Children with a history of chronic use of medications that may affect oral flora, such as long-term steroid therapy.
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 post consumption | 3. After 7 days
次要结局
- 1. The change in the pH and buffering capacity of saliva from baseline to 1-hour post consumption and after 7 days.(2. Adherence to and acceptability of the interventions, assessed through participant and caregiver reports and pill counts.)
研究者
Dr Dipanshu Kumar
Department of Dentistry, AIIMS, Gorakhpur