Effectiveness of M-Health Intervention versus Conventional Oral Health Education on Periodontal Status and Glycaemic control among Adults with Diabetes Mellitus Type 2: A Randomized Control Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes in Periodontal status, Oral Hygiene status and improvement of glycaemic levels in blood glucose in intervention group.
研究概览
简要总结
Periodontitis and diabetes are two highly prevalent non-communicable diseases whose association has long been established. A comprehensive treatment plan incorporating a common risk factor approach which includes periodontal therapy and health education can be helpful in reducing comorbidities of diabetes. Though, traditional methods that emphasize face to face and direct education have been found to be effective, in a nation like India with a large population, mHealth intervention will be effective considering the increased rate of digitalization and mobile subscriptions. Some studies that conducted in abroad, shows effectiveness of mHealth based intervention in management of Diabetes Mellitus Type 2, to my best of knowledge there is paucity of studies conducted in India with a population of diverse characteristics and lifestyle. This study is to analyze whether integrating mHealth component for diabetes management will improve the periodontal status and diabetic status of Indian population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 30 years to 65 years, diagnosed with controlled Diabetes Mellitus Type 2, under regular medical therapy ( Oral hypoglycaemics /Insulin) for last 6 months.
- •Patients having chronic periodontitis having score 3 i.e. pathological pocket of 4-5 mm and Score 1 i.e. Loss of attachment 4-5mm when assessed using Community Periodontal Index
- •At least 20 firm teeth with no mobility should be present.
- •Patients with access to mobile phone and with a minimum reading level of 5th grade.
- •Patients who are residing in Delhi.
排除标准
- •Patient who are requiring periodontal surgical treatment or splint treatment.
- •Patients who underwent significant changes in diabetes medication during the study.
- •Patients with long term history of tobacco and alcohol consumption.
结局指标
主要结局
Changes in Periodontal status, Oral Hygiene status and improvement of glycaemic levels in blood glucose in intervention group.
时间窗: Baseline,1 month, 3 months, 6 months
次要结局
未报告次要终点