Comparison of salivary biochemical and immunological biomarker in children with insulin dependent type 1 diabetes mellitus and non- diabetic children
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- to evaluate and compare salivary biochemical, immunological and microbial factors among children with T1DM and healthy children
研究概览
简要总结
Systemic disease such as diabetes compromises the salivary gland function and alteration in the chemical components and physical properties which can serve as diagnostic parameter. Saliva has several advantages such as easy storage, transport and handling, simple and non-invasive collection. The study is aimed to compare and evaluate biochemical, immunological and microbiological biomarker in children with insulin dependent diabetes mellitus and non-diabetic children. The present study will be conducted on 80 children including 40 children with confirmed type 1 diabetes mellitus and 40 diabetes free children in the age range of 5-15 years. All subjects will be instructed to refrain from eating and drinking for 1 hour before the saliva sample collection. The unstimulated saliva will be collected by spitting method. The goal of the study is to increase oral hygiene awareness of type 1 diabetes mellitus children and non- diabetic children .
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 5.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •children with insulin dependent T1DM children of 5-15 years of age parents giving consent.
排除标准
- •children with less than 5 years and above 15 years with insulin dependent T1DM children with presence of physical and mental disorder children requiring special health care needs children with genetic disease or syndromes children on any other systemic medications.
结局指标
主要结局
to evaluate and compare salivary biochemical, immunological and microbial factors among children with T1DM and healthy children
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
Dr Rajas Mahalle
Rajarajeshwari dental college and hospital, Kumbalgodu, bangalore