Using Artificial Intelligence-platform on Plaque Control and Periodontal Treatment Outcome in Patients With Periodontal Disease-Preliminary Results
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
- Protection Motivation Theory (PMT) scores
研究概览
简要总结
The aim of this study was to evaluate the long-term effectiveness of an AI dental monitoring intervention on patients' periodontal disease, preventive behaviors and motivation. This randomized controlled trial included experimental group: AI group (EG-A), AI-humanized group (EG-B) and control group(CG), respectively.
The EG-A and EG-B received AI dental monitoring intervention by taking mouth image at home once a week for six month.
Baseline and follow-up surveys were used to collect the data in periodontal index, periodontal preventive behavior and motivation.
详细描述
A randomized experimental design was used. Patients with periodontal disease whose aged 35-65 years were recruited through department of Periodontics 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 follow-ups.
Each patients will be diagnosed periodontal disease by dentist and have more than 16 functional teeth.
Each patients will completed the questionnaire at baseline and at 1-month, 3-month and 6-month 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 between 35-65 years old
- •Diagnosed periodontal disease by dentist (Comprehensive Periodontal Treatment Project)
- •More than 16 functional teeth
排除标准
- •Have received periodontal treatment within 3 months
- •Patient has disease related to periodontal disease (ex. Drug-related excessive gum growth or blood clotting problems, pregnancy, mental illness)
- •Disability patients
结局指标
主要结局
Protection Motivation Theory (PMT) scores
时间窗: Change from Baseline PMT at 6-month after intervention
Item including that "I think periodontal disease is a serious disease" "If I do not have periodontal disease prevention behavior, the risk of developing periodontal disease in the future is very high" "If I stick to periodontal disease prevention behavior, it will improve my oral health" "I believe that I can follow the periodontal health guidance" "I find it hard to remember/hard to do periodontal health care guidance" "Periodontal disease bothers me" "I want to complete my personal periodontal disease prevention behavior plan" All the items' scores ranged from one to ten, with higher scores indicating a higher level of motivation toward change behaviors. Cronbach's α was 0.70 for this scale. The scores ranged from one ("impossible") to ten ("very possible"), with the total possible score ranging from seven to seventy.
gingival index (GI)
时间窗: Change from Baseline GI at 6-month 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 6-month 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 6-month 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.
Clinical Attachment Loss(CAL)
时间窗: Change from Baseline CAL at 6-month 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 self-care behavior(Change from Baseline at 6 month after intervention)
- OHIP-14T scales(Change from Baseline at 6 month after intervention)