Using Artificial Intelligence-platform on Plaque Control and Periodontal Treatment Outcome in Patients With Periodontal Disease-Preliminary Results

NCT04567030 | Recruiting

• 1 other identifier: KMUHIRB-E(I)-20190141
• 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 periodontal index, periodontal preventive behavior and motivation.

Conditions

Periodontal Diseases

Keywords

oral hygiene; artificial intelligence; Periodontitis; Periodontal Diseases

Outcome Measures

Primary Outcomes (15)

• gingival index (GI)

  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 12,16,24,32,36,44

  Change from Baseline GI at 1-month after intervention

• gingival index (GI)

  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 12,16,24,32,36,44

  Change from Baseline GI at 3-month after intervention

• gingival index (GI)

  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 12,16,24,32,36,44

  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. For each patient, PPD will measured each teeth.

  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. For each patient, PPD will measured each teeth.

  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. For each patient, PPD will measured each teeth.

  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. 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. 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. For each patient, CAL will measured each teeth.

  Change from Baseline CAL at 6-month after intervention

• 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.

  Change from Baseline PMT at 1-month after intervention

• 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.

  Change from Baseline PMT at 3-month after intervention

• 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.

  Change from Baseline PMT at 6-month after intervention

Secondary Outcomes (6)

• oral self-care behavior

  Change from Baseline at 1 month after intervention

• oral self-care behavior

  Change from Baseline at 3 month after intervention

• oral self-care behavior

  Change from Baseline at 6 month after intervention

• OHIP-14T scales

  Change from Baseline at 1 month after intervention

• OHIP-14T scales

  Change from Baseline at 3 month after intervention

Study Arms (3)

Experimental group A (AI Group: EG-A)

EXPERIMENTAL

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.

Device: Dental monitoring (DM)

Experimental group B (AI with humanized Group: EG-B)

EXPERIMENTAL

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.

Device: Dental monitoring (DM)

Control group (CG)

NO INTERVENTION

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

Interventions

Dental monitoring (DM) DEVICE

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 with humanized 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

Related Publications (1)

• Shen KL, Huang CL, Lin YC, Du JK, Chen FL, Kabasawa Y, Chen CC, Huang HL. Effects of artificial intelligence-assisted dental monitoring intervention in patients with periodontitis: A randomized controlled trial. J Clin Periodontol. 2022 Oct;49(10):988-998. doi: 10.1111/jcpe.13675. Epub 2022 Jul 10.

  PMID: 35713224 DERIVED

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

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: September 24, 2020
• First Posted: September 28, 2020
• Study Start: November 16, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

TW (1)