Evaluation And Comparison Of Salivary Aquaporin-5 Level and Streptococcus Mutans Counts In Children Before And After Consumption Of Milk Sweetend With Xylitol,D-Allulose And Monk Fruit Sugar Substitutes-An In vivo study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
研究概览
简要总结
A total of 45 eligible children will be randomly allocated into three groups with15 each
Group 1 Healthy Children receiving milk sweetened with xylitol sugar substitute.
Group 2 Healthy Children receiving milk sweetened with D Allulose sugar substitute.
Group 3 Healthy Children receiving milk sweetened with Monk Fruit sugar substitute.
All participants will be instructed to refrain from eating or drinking for one hour prior to saliva collection. Children are instructed to rinse with filtered water and Pre intervention unstimulated saliva samples will be collected using spitting method. Samples will be collected over a period of five minutes, sealed immediately and stored at minus 20 degree celsius.
Intervention protocol
Group 1. 4g per day xylitol, 2g with 100ml milk in the morning and evening.
Group 2. 4g per day D Allulose, 2g with 100ml milk in the morning and evening.
Group 3. 1g per day Monk Fruit sugar substitute ,0.5g with 100ml of milk in the morning and evening to be followed for 1 month.
Bilingual instruction sheets will be provided to parents and daily reminder notification will be sent through a mobile application app every morning and evening to ensure compliances. Post intervention saliva samples will be collected after one month following the same protocol. All samples will be analysed for Aquaporin 5 using ELISA and for Streptococcus mutans using Mitis salivarius bacitracin agar.
The results obtained will be subjected to statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Children aged 5-9 years of age.
- •Children with DMFT or dmft DC greater than or equal to 3, ICDAS 2 criteria with CODE 03 and
- •3.Children who have not previously received sugar substitute therapy.
- •4.Children without any systemic disease.
- •Children who consumes milk at least three times per week.
- •6.No history of intolerance or adverse reaction to milk or sugar substitutes.
- •7.Written informed consent obtained from parents or guardians.
排除标准
- •1.Children with metabolic disorders, gastrointestinal Diseases and severe chronic illnesses.
- •2.Children with milk protein allergy, lactose intolerance or known hypersensitivity to sugar substitutes.
- •3.Children with Recent history of antibiotic usage.
- •Parents or children are unwilling to participate in the study.
研究者
Dr Prathibha Gunasekaran
Rajarajeswari Dental College and Hospital