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

Primary Purpose

Periodontal Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
The AI-assisted tool used in this study was called Dental Monitoring (DM).
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontal Diseases focused on measuring periodontal disease, artificial intelligence (AI), OHRQoL

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Experimental group A (AI Group: EG-A)

Experimental group B (AI and health counseling group: EG-B)

No Intervention: Control group (CG)

Arm Description

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.

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.

the control group(CG) only have standard oral hygiene education

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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 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
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 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
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 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
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.
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.
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.

Full Information

First Posted
October 9, 2023
Last Updated
October 20, 2023
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06083649
Brief Title
The Dental Care Revolution: Health Education Using AI or Humanized Counseling on Plague Control and Periodontal Treatment Outcome in Patients With Periodontal Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
periodontal disease, artificial intelligence (AI), OHRQoL

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group A (AI Group: EG-A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental group B (AI and health counseling group: EG-B)
Arm Type
Experimental
Arm Description
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.
Arm Title
No Intervention: Control group (CG)
Arm Type
No Intervention
Arm Description
the control group(CG) only have standard oral hygiene education
Intervention Type
Behavioral
Intervention Name(s)
The AI-assisted tool used in this study was called Dental Monitoring (DM).
Intervention Description
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.
Primary Outcome Measure Information:
Title
gingival index (GI)
Description
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
Time Frame
Change from Baseline GI at 1-month after intervention
Title
gingival index (GI)
Description
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
Time Frame
Change from Baseline GI at 3-month after intervention
Title
gingival index (GI)
Description
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
Time Frame
Change from Baseline GI at 6-month after intervention
Title
plaque index (PI)
Description
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
Time Frame
Change from Baseline PI at 1-month after intervention
Title
plaque index (PI)
Description
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
Time Frame
Change from Baseline PI at 3-month after intervention
Title
plaque index (PI)
Description
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
Time Frame
Change from Baseline PI at 6-month after intervention
Title
Probing Pocket Depth (PPD)
Description
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.
Time Frame
Change from Baseline PPD at 1-month after intervention
Title
Probing Pocket Depth (PPD)
Description
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.
Time Frame
Change from Baseline PPD at 3-month after intervention
Title
Probing Pocket Depth (PPD)
Description
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.
Time Frame
Change from Baseline PPD at 6-month after intervention
Title
Clinical Attachment Loss(CAL)
Description
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.
Time Frame
Change from Baseline CAL at 1-month after intervention
Title
Clinical Attachment Loss(CAL)
Description
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.
Time Frame
Change from Baseline CAL at 3-month after intervention
Title
Clinical Attachment Loss(CAL)
Description
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.
Time Frame
Change from Baseline CAL at 6-month after intervention
Title
OHRQoL(OHIP-14T scales)
Description
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.
Time Frame
Change from Baseline at 1 month after intervention
Title
OHRQoL(OHIP-14T scales)
Description
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.
Time Frame
Change from Baseline at 3 month after intervention
Title
OHRQoL(OHIP-14T scales)
Description
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.
Time Frame
Change from Baseline at 6 month after intervention
Secondary Outcome Measure Information:
Title
Protection Motivation Theory (PMT) scores
Description
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
Time Frame
Change from Baseline PMT at 1-month after intervention
Title
Protection Motivation Theory (PMT) scores
Description
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
Time Frame
Change from Baseline PMT at 3-month after intervention
Title
Protection Motivation Theory (PMT) scores
Description
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
Time Frame
Change from Baseline PMT at 6-month after intervention
Title
oral self-care behavior
Description
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.
Time Frame
Change from Baseline at 1 month after intervention
Title
oral self-care behavior
Description
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.
Time Frame
Change from Baseline at 3 month after intervention
Title
oral self-care behavior
Description
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.
Time Frame
Change from Baseline at 6 month after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiao-Ling Huang, Dr.PH
Organizational Affiliation
Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FU-TZU YOU
Phone
+886-7-3121101
Ext
2159
Email
alicedh110@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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