The Dental Care Revolution: Health Education Using AI or Humanized Counseling on Plague Control and Periodontal Treatment Outcome in Patients With Periodontal Disease

Periodontal Diseases Clinical Trial

Official title:

The Dental Care Revolution: Health Education Using AI or Humanized Counseling on Plague Control and Periodontal Treatment Outcome in Patients With Periodontal Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083649
• Other study ID #: KMUHIRB-F(II)-20200059
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Behavioral:
• The AI-assisted tool used in this study was called Dental Monitoring (DM).
DM is the first APP system used in orthopedics patients in the world,it has been widely used in Asian countries (Taiwan, Hong Kong, Singapore, Japan,etc.) and has been used by 2140 patients so far. DM allows patients to take in-mouth photos at home, and uses AI as a background analysis to evaluate the patient's current oral condition (including oral hygiene and gum status) based on the photo.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gingival index (GI)	The gingival inflammation status of 6 tooth was recorded using the gingiva index, as follows: 0 = No inflammation.; = Mild inflammation, slight change in color, slight edema, no bleeding on probing; = Moderate inflammation, moderate glazing, redness, bleeding on probing; = 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	Change from Baseline GI at 1-month after intervention
Primary	gingival index (GI)	The gingival inflammation status of 6 tooth was recorded using the gingiva index, as follows: 0 = No inflammation.; = Mild inflammation, slight change in color, slight edema, no bleeding on probing; = Moderate inflammation, moderate glazing, redness, bleeding on probing; = 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	Change from Baseline GI at 3-month after intervention
Primary	gingival index (GI)	The gingival inflammation status of 6 tooth was recorded using the gingiva index, as follows: 0 = No inflammation.; = Mild inflammation, slight change in color, slight edema, no bleeding on probing; = Moderate inflammation, moderate glazing, redness, bleeding on probing; = 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	Change from Baseline GI at 6-month after intervention
Primary	plaque index (PI)	The plaque status of 6 tooth was recorded using the plaque index, as followes: 0 = No plaque; = Thin film of plaque, scraped with explorer; = Moderate amount of plaque, visible with naked eyes; = 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	Change from Baseline PI at 1-month after intervention
Primary	plaque index (PI)	The plaque status of 6 tooth was recorded using the plaque index, as followes: 0 = No plaque; = Thin film of plaque, scraped with explorer; = Moderate amount of plaque, visible with naked eyes; = 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	Change from Baseline PI at 3-month after intervention
Primary	plaque index (PI)	The plaque status of 6 tooth was recorded using the plaque index, as followes: 0 = No plaque; = Thin film of plaque, scraped with explorer; = Moderate amount of plaque, visible with naked eyes; = 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	Change from Baseline PI at 6-month after intervention
Primary	Probing Pocket Depth (PPD)	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.	Change from Baseline PPD at 1-month after intervention
Primary	Probing Pocket Depth (PPD)	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.	Change from Baseline PPD at 3-month after intervention
Primary	Probing Pocket Depth (PPD)	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.	Change from Baseline PPD at 6-month after intervention
Primary	Clinical Attachment Loss(CAL)	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.	Change from Baseline CAL at 1-month after intervention
Primary	Clinical Attachment Loss(CAL)	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.	Change from Baseline CAL at 3-month after intervention
Primary	Clinical Attachment Loss(CAL)	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.	Change from Baseline CAL at 6-month after intervention
Primary	OHRQoL(OHIP-14T scales)	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.	Change from Baseline at 1 month after intervention
Primary	OHRQoL(OHIP-14T scales)	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.	Change from Baseline at 3 month after intervention
Primary	OHRQoL(OHIP-14T scales)	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.	Change from Baseline at 6 month after intervention
Secondary	Protection Motivation Theory (PMT) scores	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 a 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	Change from Baseline PMT at 1-month after intervention
Secondary	Protection Motivation Theory (PMT) scores	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 a 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	Change from Baseline PMT at 3-month after intervention
Secondary	Protection Motivation Theory (PMT) scores	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 a 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	Change from Baseline PMT at 6-month after intervention
Secondary	oral self-care behavior	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.	Change from Baseline at 1 month after intervention
Secondary	oral self-care behavior	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.	Change from Baseline at 3 month after intervention
Secondary	oral self-care behavior	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.	Change from Baseline at 6 month after intervention