Evaluation of Salivary and Plaque Acidogenicity of Various Sweeteners in Milk Among Children: An In Vivo Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Changes in salivary acidogenicity and plaque acidogenicity (measured by pH levels) after exposure to the milk with various sweeteners.
研究概览
简要总结
This pilot study aims to evaluate the effect of different sweeteners (white sugar, palm sugar, dates syrup) on salivary and plaque acidogenicity in children aged 6-8 years. The participants will be randomly assigned to one of five groups: control (10% sucrose), plain milk, milk with white sugar, milk with palm sugar, or milk with dates syrup. The primary outcome is the change in salivary and plaque pH levels within 30 minutes post-intervention. The study will also compare acidogenicity across the sweeteners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: Children aged between 6 to 8 years.
- •Dental Status: Children with a DMFT (Decayed, Missing, and Filled Teeth) score less than
- •Health Status: Healthy children without any systemic diseases.
- •Oral Hygiene: Children with a Good Oral Hygiene Index.
- •Behavioral Assessment: Children scoring 3 (positive) or 4 (definitely positive) on Frankl’s Behavior Rating Scale.
排除标准
- •1.Children who are not in the habit of consuming milk.
- •2.Children who have an intolerance to milk protein.
- •3.Children who have a history of recent hospitalization, take medications that affect the salivary flow rate.
- •4.Medically compromised children.
- •5.Children having unerupted / partially erupted 1st permanent molars.
结局指标
主要结局
1.Changes in salivary acidogenicity and plaque acidogenicity (measured by pH levels) after exposure to the milk with various sweeteners.
时间窗: Changes in salivary acidogenicity and plaque acidogenicity (measured by pH levels) after exposure to the milk with various sweeteners | at baseline,5 minutes,10 minutes,20minutes and 30 minutes.
2.The interventionional impact on the pH levels of saliva and plaque will be measured to assess the acidogenic potential of the sweeteners.
时间窗: Changes in salivary acidogenicity and plaque acidogenicity (measured by pH levels) after exposure to the milk with various sweeteners | at baseline,5 minutes,10 minutes,20minutes and 30 minutes.
次要结局
未报告次要终点
研究者
SWETHA T
Tagore Dental College And Hospital