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

NCT06083649 | Recruiting

• 1 other identifier: KMUHIRB-F(II)-20200059
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Keywords

periodontal disease; artificial intelligence (AI); OHRQoL

Outcome Measures

Primary Outcomes (15)

• gingival index (GI)

  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

  Change from Baseline GI at 1-month after intervention

• gingival index (GI)

  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

  Change from Baseline GI at 3-month after intervention

• gingival index (GI)

  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

  Change from Baseline GI at 6-month after intervention

• plaque index (PI)

  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

  Change from Baseline PI at 1-month after intervention

• plaque index (PI)

  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

  Change from Baseline PI at 3-month after intervention

• plaque index (PI)

  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

  Change from Baseline PI at 6-month after intervention

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• 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

• Protection Motivation Theory (PMT) scores

  Change from Baseline PMT at 6-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

Study Arms (3)

Experimental group A (AI Group: EG-A)

EXPERIMENTAL

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.

Behavioral: The AI-assisted tool used in this study was called Dental Monitoring (DM).

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

EXPERIMENTAL

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.

Behavioral: The AI-assisted tool used in this study was called Dental Monitoring (DM).

No Intervention: Control group (CG)

NO INTERVENTION

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

Interventions

The AI-assisted tool used in this study was called Dental Monitoring (DM). BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 35-65 years old
• Diagnosed periodontal disease by dentist (Comprehensive Periodontal Treatment Project)
• More than 16 functional teeth

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Hsiao-Ling Huang, Dr.PH

  Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiao-Ling Huang

CONTACT

+886-7-312-1101#2159; hhuang@kmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: August 10, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

TW (1)