Effect of Fermented Rice Water(FRW) and Probiotic curd on salivary pH in 5–12-year-old children – A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference in change in salivary pH before and after use of Fermented Rice water and Probiotic curd.
研究概览
简要总结
Early childhood dental caries remains a major public health concern, with salivary pH playing a crucial role in the initiation and progression of the caries process. Natural, diet-based preventive strategies such as probiotics and fermented foods have gained attention due to their ability to modulate the oral microbiome and maintain salivary pH balance. Fermented rice water (FRW) and probiotic curd (PC) are traditional, cost-effective dietary products commonly consumed in Indian households and are known to possess probiotic properties.
The present study is a randomized controlled trial designed to evaluate and compare the effect of fermented rice water and probiotic curd on salivary pH in children aged 5–12 years. Eligible participants will be randomly allocated into three groups: Group I (fermented rice water), Group II (probiotic curd), and Group III (control group). Baseline salivary pH will be recorded, followed by intervention-specific administration for a defined period, after which post-intervention salivary pH will be assessed.
The primary outcome measure of the study is the change in salivary pH before and after the intervention. The findings of this study aim to provide scientific evidence regarding the role of traditional probiotic food products in maintaining oral pH and enhancing preventive strategies in pediatric dentistry. If proven effective, these easily accessible and economical dietary interventions could be incorporated into routine oral health promotion programs for children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •Children who give assent to participate in the study and whose parents give written informed consent.
- •Healthy children without any Developmental Abnormalities or Medical Condition.
排除标准
- •Children with a history of taking any antibiotic treatment 1 month prior to the study period and throughout the study period Children on any other supplements containing probiotics during the study.
- •Lactose intolerant subjects Children on use of xylitol products for 3 weeks before and throughout the study.
结局指标
主要结局
Difference in change in salivary pH before and after use of Fermented Rice water and Probiotic curd.
时间窗: Baseline sample - before intervention | First Day Post Intervention Sample | Post Intervention Sample at 15th day
次要结局
- To evaluate & compare changes in the selected salivary parameters before & after swishing & spitting of Fermented Rice Water & Probiotic Curd –(Buffering Capacity using Ericson’s method & Digital pH meter)
研究者
Dr Isha Shahapurkar
Government Dental College Kottayam
