Effectiveness of Preventive Oral Healthcare Package Versus Conventional Method of Oral Healthcare on Oral Health Status and Glycemic Control among Children with Type 1 Diabetes Mellitus: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Rashmi Misra
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes in oral health status, oral hygiene practices and caries incidence (incipient
概览
简要总结
This study is a double blinded, Two-Arm, Parallel time series, Randomized Controlled Trial comparing the effectiveness of Preventive Oral Healthcare Package versus conventional method of oral healthcare on oral health status and glycemic control among children with Type 1 Diabetes Mellitus that will be conducted in Department of Public Health Dentistry, Maulana Azad Institute of Dental Sciences, New Delhi in India. The primary outcome measure will be changes in oral health status, oral hygiene practices and caries incidence (incipient caries) in intervention group at 1, 3 and 6 months after implementation of preventive oral healthcare package. The secondary outcome will be improvement of glycemic levels in intervention group, changes in utilization of dental services and Oral health related quality of life in intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects of either sex between the age group of 6 to 14 years, diagnosed with Type 1 Diabetes Mellitus 2.Patient diagnosed with Type 1 Diabetes Mellitus for at least 6 months back.
排除标准
- •1.Patients with known history of any other systemic diseases 2.Presence of periapical pathological lesions 3.Patients who underwent dental treatment in the past 6 months 4.Presence of congenital dental disorders.
结局指标
主要结局
Changes in oral health status, oral hygiene practices and caries incidence (incipient
时间窗: Assessments will be conducted at 1 month, 3 months and 6 months after implementation of Preventive Oral Healthcare Package
caries) in intervention group
时间窗: Assessments will be conducted at 1 month, 3 months and 6 months after implementation of Preventive Oral Healthcare Package
次要结局
- Improvement of glycemic levels in intervention group, changes in utilization of dental services and OHRQoL in intervention group(Assessments will be conducted at 1 month, 3 months and 6 months after implementation of Preventive Oral Healthcare Package)
研究者
Rashmi Misra
Maulana Azad Institute of Dental Sciences