Effect of 5% Aqueous Propolis Added to Sugar-Free Chewing Gum in Salivary and Dental Plaque pH in Children (in Vivo Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Saliva pH measurement
研究概览
简要总结
This study aims to investigate the changes in saliva and dental plaque pH after consuming sugar-free chewing gum containing 5% of aqueous propolis in children aged between 8-11 years. The studied sample will be divided into two groups: Group A (Control group) placebo chewing gum, and Group B (Experimental group) aqueous propolis chewing gum. All children will experience both types of chewing gum with an interval of 1 week between the two studied groups.
详细描述
This study will evaluate saliva and dental plaque pH after consuming 10% sucrose solution and then each child will test each of the two types of gum (aqueous propolis 5% and placebo gum) so that the child himself is the control and tested sample together, according to the following order:
- In the first visit: the pH of saliva and dental plaque will be measured (before giving the sucrose solution, while chewing one of the two types of gum, and after giving the sucrose solution).
- In the second visit: after a week, the pH of saliva and dental plaque will be measured (before giving the sucrose solution, while chewing the other types of gum, and after giving the sucrose solution).)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children have mixed occlusion.
- •Integrity of the buccal surfaces of the reference teeth (16, 21, 26, 36, 41, 46) from caries and developmental disorders
- •Children with DMFS ≥5 according to WHO guidelines and standards.
排除标准
- •Systematic or mental disorders
- •Medications that may affect the salivary flow rate or composition.
- •Allergy to natural sugar substitutes.
- •Children who wear fixed or removable orthodontic appliances.
- •Children who have the habit of daily use of sugar substitute products.
结局指标
主要结局
Saliva pH measurement
时间窗: 15 minutes after chewing gum.
saliva pH will be measured by using saliva pH meter.
次要结局
- Dental plaque pH measurement(15 minutes after chewing gum.)