The Dental Care Revolution: Health Education Using AI or Humanized Counseling on Plague Control and Periodontal Treatment Outcome in Patients With Periodontal Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- gingival index (GI)
Study Overview
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 oral health related quality of life,periodontal parameters, periodontal preventive behaviors 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 35 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 35-65 years old
- •Diagnosed periodontal disease by dentist (Comprehensive Periodontal Treatment Project)
- •More than 16 functional teeth
Exclusion Criteria
- •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
Arms & Interventions
Experimental group A (AI Group: EG-A)
The AI group scanned their own mouths at home once a week for 6 months, with each scan taking approximately 5 min. After scanning, they uploaded the results to the AI system for evaluation. The AI system then selected and sent a message to each patient depending on their intraoral conditions.
Intervention: The AI-assisted tool used in this study was called Dental Monitoring (DM). (Behavioral)
Experimental group B (AI and health counseling group: EG-B)
The AI and health counseling group scanned their own mouths at home once a week for 6 months, with each scan taking approximately 5 min. After scanning, they uploaded the results to the AI system for evaluation. The EG-B received both AI-assisted DM and real-person oral health counseling and advice from a counselor, who assessed their oral hygiene conditions on the basis of their scanning results and then provided individualized counseling, such as pointing out unclean teeth and offering suggestions on cleaning tools.
Intervention: The AI-assisted tool used in this study was called Dental Monitoring (DM). (Behavioral)
No Intervention: Control group (CG)
the control group(CG) only have standard oral hygiene education
Outcomes
Primary Outcomes
gingival index (GI)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.
gingival index (GI)
Time Frame: Change from Baseline GI at 1-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
gingival index (GI)
Time Frame: Change from Baseline GI at 3-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)
Time Frame: Change from Baseline PI at 1-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
plaque index (PI)
Time Frame: Change from Baseline PI at 3-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)
Time Frame: Change from Baseline PPD at 1-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.
Probing Pocket Depth (PPD)
Time Frame: Change from Baseline PPD at 3-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.
Clinical Attachment Loss(CAL)
Time Frame: Change from Baseline CAL at 1-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.
Clinical Attachment Loss(CAL)
Time Frame: Change from Baseline CAL at 3-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.
OHRQoL(OHIP-14T scales)
Time Frame: Change from Baseline at 1 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.
OHRQoL(OHIP-14T scales)
Time Frame: Change from Baseline at 3 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.
Secondary Outcomes
- 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)
- Protection Motivation Theory (PMT) scores(Change from Baseline PMT at 1-month after intervention)
- Protection Motivation Theory (PMT) scores(Change from Baseline PMT at 3-month after intervention)
- oral self-care behavior(Change from Baseline at 1 month after intervention)
- oral self-care behavior(Change from Baseline at 3 month after intervention)