The Dental Care Revolution: Health Education Using AI or Humanized Counseling on Plague Control and Periodontal Treatment Outcome in Patients With Periodontal Disease
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 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 oral health related quality of life,periodontal parameters, periodontal preventive behaviors 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
gingival index (GI)
时间窗: Change from Baseline GI at 6-month after intervention
The gingival 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
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. - Page 4 of 8 - For each patient, CAL will measured each teeth.
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, recorded at six sites (mesial \[buccal and lingual/palatal\], distal \[buccal and lingual/palatal\], mid-buccal, and mid-lingual/palatal) around each tooth, except for the third molar.
OHRQoL(OHIP-14T scales)
时间窗: Change from Baseline at 6 month after intervention
Item including that because of problems with your teeth or mouth, you: * Have you had trouble pronouncing any words because of problems" * Have you felt that your sense of taste has worsened" * Have you had painful aching in your mouth" * Have you found it uncomfortable to eat any foods" * Have you been self-conscious" * Have you felt tense" * Has been your diet been unsatisfactory" * Have you had to interrupt meals?" * Have you found it difficult to relax" * Have you been a bit embarrassed" * Have you been a bit irritable with other people" * Have you had difficulty doing your usual jobs" * Have you felt that life in general was less satisfying" * Have you been totally unable to function" Responses are scored on a 5-point Likert scale with endpoints ranging from 0 (never) to 4 (very often), indicating the frequency of the problem over the preceding 6 months. The possible scores were 0-56, with lower scores indicating more favorable OHRQoL.
次要结局
- oral self-care behavior(Change from Baseline at 6 month after intervention)
- Protection Motivation Theory (PMT) scores(Change from Baseline PMT at 6-month after intervention)