Using Augmented Reality Dental Care Training in Health Education on Periodontal Status, Blood Sugar Control and Quality of Life in Patients With Poorly Controlled Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Gingival index (GI)
研究概览
简要总结
The aim of this study was to evaluate the long-term effectiveness of an AR dental care training in health education on periodontal status, blood sugar control and quality of life in patients with poorly controlled type 2 diabetes. This randomized controlled trial included experimental group: AR group (EG-A), AR-health consulting group (EG-B) and control group (CG), respectively.
The EG-A and EG-B received AR dental care training intervention 2 to 3 times during non-surgical periodontal treatment.
Baseline and follow-up surveys were used to collect the data in periodontal index, blood sugar data, oral health knowledge, attitudes, behavior, oral health-related quality of life.
详细描述
A randomized experimental design was used. Patients with type 2 diabetes whose aged 35-65 years and HbA1c over 7% in the past six months were recruited through department of Endocrinology and Metabolism in Kaohsiung Medical University Hospital.
Each group was expected for 100 per group, patients will be randomized into each group. G*Power (version 3.1.9.4) was used for power analysis.
All patients will underwent periodontal examination at baseline and at 1-month, 3-month, 6-month and 1 year follow-ups.
Each patients will be diagnosed periodontal disease by dentist and have more than 12 functional teeth.
Each patients will completed the questionnaire at baseline and at 1-month, 3- month,6-month and 1 year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 35 years old (inclusive) and above
- •HbA1c over 7% in the past six months
- •There are more than 12 functional teeth to ensure that the patient has enough teeth to evaluate the periodontal condition
排除标准
- •Have received periodontal treatment within the previous 6 months
- •Habits of smoking, drugs and betel nut chewing
- •Taking antibiotics and osteoporosis bisphosphonates and other drugs regularly
- •People with cognitive function or physical and mental disabilities
- •Severely impaired diseases (for example: cancer, renal function or liver failure, etc.)
结局指标
主要结局
Gingival index (GI)
时间窗: Change from Baseline GI at 1 year after intervention
The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows: 0 = No inflammation. 1. = Mild inflammation, slight change in color, slight edema, no bleeding on probing 2. = Moderate inflammation, moderate glazing, redness, bleeding on probing 3. = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding. For each patient, GI will measured by the teeth 12,16,24,32,36,44
Plaque index (PI)
时间窗: Change from Baseline PI at 1 year after intervention
The plaque status of 6 tooth was recorded using the plaque index, as followes: 0 = No plaque 1. = Thin film of plaque, scraped with explorer 2. = Moderate amount of plaque, visible with naked eyes 3. = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. For each patient, PI will measured by the teeth 12,16,24,32,36,44
Probing Pocket Depth (PPD)
时间窗: Change from Baseline PPD at 1 year after intervention
Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin. For each patient, PPD will measured each teeth.
Plaque Control Record (PCR)
时间窗: Change from Baseline PCR at 1 year after intervention
The Plaque Control Record is a very simple percentage or score of the total amount of bacteria present in your mouth. A tooth has 6 surfaces at the gum line being; the lingual side (distal, middle, mesial) and buccal side (distal, middle, mesial). For each patient, PCR will measured each teeth.
Clinical Attachment Loss(CAL)
时间窗: Change from Baseline CAL at 1 year after intervention
Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket. For each patient, CAL will measured each teeth.
次要结局
- Oral Health Related Quality of Life(OHRQoL)(Change from Baseline at 1 year after intervention)
- Oral health knowledge(Change from Baseline at 1 year after intervention)
- Attitude toward oral health(Change from Baseline at 1 year after intervention)