Using Artificial Intelligence-platform on Plaque Control and Periodontal Treatment Outcome in Patients With Periodontal Disease-Preliminary Results
- Conditions
- Periodontal Diseases
- Interventions
- Device: Dental monitoring (DM)
- Registration Number
- NCT04567030
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Age between 35-65 years old
- Diagnosed periodontal disease by dentist (Comprehensive Periodontal Treatment Project)
- More than 16 functional teeth
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group A (AI Group: EG-A) Dental monitoring (DM) Behavioral: AI intervention For the EG-A, a AI scan box will give to patients that taking mouth image at home once a week until six-month. The AI will send automated message to patients' mobile phone telling about their oral hygiene condition, gum condition, tooth condition. Experimental group B (AI with humanized Group: EG-B) Dental monitoring (DM) Behavioral: AI intervention For the EG-B,a AI scan box will give to patients that taking mouth image at home once a week until six-month. The AI will send automated message to patients' mobile phone telling about their oral hygiene condition, gum condition, tooth condition. The humanized counseling will also send to patients' mobile phone about each patients oral hygiene condition and advises.
- Primary Outcome Measures
Name Time Method Protection Motivation Theory (PMT) scores 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) 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 12,16,24,32,36,44plaque index (PI) 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 12,16,24,32,36,44Probing Pocket Depth (PPD) 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) 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.
- Secondary Outcome Measures
Name Time Method oral self-care behavior Change from Baseline at 6 month after intervention Item including that "How many times do you brush your teeth a day?" The response was (once or twice day or three times or fours times or more/ day).
"How long do you usually brush your teeth each time?" The response was lower than 1 min or 1-2 min or 2-3 min or more than 3 min/ day.
"What is your main method of brushing your teeth?"The response was horizontally or vertically or Circle brush or Rotating brush or Horizontal+vertical+ and by the gum at a 45 degree angle. "How often do you replace your toothbrush?" The response was 3-6 month or more than 6 month or lower than 1 month or 1-2 month or 2-3 month.
"Do you use a soft-bristled toothbrush?" The response was no or unknown or yes. "Do you have a habit of using interdental brushes?" The response was no or yes. "Do you have a habit of eating snack?" The response was no or yes.OHIP-14T scales 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" The scores ranged from one ("never") to five ("always"), with the total possible score ranging from fourteen to seventy.
Trial Locations
- Locations (1)
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan