Comparative evaluation of Oral hygiene and hydration status of athletes aged 10 – 14 years consuming Kangen water, energy sports drink & normal water. A Randomized controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- To evaluate & compare plaque level, salivary pH, and Streptococcus Mutans in athletes consuming Kangen water, energy sports drinks, and normal water. at baseline, 14 days and 28 days interval.
研究概览
简要总结
This study is prospective, three-arm, single-blinded Randomized controlled trial evaluating the oral hygeine of athlets of aged 10-14 years old consuming kangen water, energy sport drink and normal water as a primary objective & evaluate & compare the hydration status (body weight, heart rate, blood pressure, breathing rate, body temperature) of athletes consuming Kangen water, energy sports drinks & normal water as additional objectives and evaluate the acceptance of Kangen water, energy sports drinks, and normal water as an energy enhancer by athletes 10 – 14 years old.
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
- 10.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Athlete of age group 10-14 years.
- •Athlete with body mass index (BMI) between 18.5-24.9 Athletes who are willing to participate in the study.
排除标准
- •Athlete having any systemic disease.
- •History of oral prophylaxis at least 3 months before study.
- •History of antibiotic therapy at least 3 months before study.
- •Parents or caretakers not willing to participate in this study.
结局指标
主要结局
To evaluate & compare plaque level, salivary pH, and Streptococcus Mutans in athletes consuming Kangen water, energy sports drinks, and normal water. at baseline, 14 days and 28 days interval.
时间窗: To evaluate & compare plaque level, salivary pH, and Streptococcus Mutans in athletes consuming Kangen water, energy sports drinks, and normal water. at baseline, 14 days and 28 days interval.
次要结局
- To evaluate & compare the hydration status (body weight, heart rate, blood pressure, breathing rate, body temperature) of athletes consuming Kangen water, energy sports drinks & normal water.(To evaluate the acceptance of Kangen water, energy sports drinks, & normal water as an energy enhancer by athletes 10 – 14 years old.)
研究者
Utkarsha Kadam
Government Dental College and Hospital Nagpur