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Recruiting Not applicable

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

NCT04567030 · tracked via the Priya Life Science Taiwan tracker
Phase
Not applicable
Started
2019-11-16
Last updated
2025-02-06

Condition(s) studied

Periodontal Diseases

Investigational drug(s) / intervention(s)

Dental monitoring (DM)

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.

Study 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.

Eligibility

Sex
ALL
Min age
35 Years
Max age
65 Years
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

Primary outcome measure(s)

  • gingival index (GI) — Change from Baseline GI at 1-month after intervention
    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
  • gingival index (GI) — Change from Baseline GI at 3-month after intervention
    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
  • gingival index (GI) — Change from Baseline GI at 6-month after intervention
    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
  • plaque index (PI) — 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) — 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
  • plaque index (PI) — 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
  • Probing Pocket Depth (PPD) — 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. For each patient, PPD will measured each teeth.
  • Probing Pocket Depth (PPD) — 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. For each patient, PPD will measured each teeth.
  • Probing Pocket Depth (PPD) — 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. For each patient, PPD will measured each teeth.
  • Clinical Attachment Loss(CAL) — 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. For each patient, CAL will measured each teeth.
  • Clinical Attachment Loss(CAL) — 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. For each patient, CAL will measured each teeth.
  • Clinical Attachment Loss(CAL) — 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. For each patient, CAL will measured each teeth.
  • Protection Motivation Theory (PMT) scores — Change from Baseline PMT at 1-month after intervention
    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 — Change from Baseline PMT at 3-month after intervention
    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 — Change from Baseline PMT at 6-month after intervention
    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.

Trial sites (1)

FacilityCityRegionStatus
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City Taiwan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04567030 on ClinicalTrials.gov ↗ ← All trials in Taiwan