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Recruiting Not applicable

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

NCT06083649 · tracked via the Priya Life Science Taiwan tracker
Phase
Not applicable
Started
2020-08-10
Last updated
2025-02-06

Condition(s) studied

Periodontal Diseases

Investigational drug(s) / intervention(s)

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

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.

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 oral health related quality of life,periodontal parameters, periodontal preventive behaviors 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 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
  • gingival index (GI) — Change from Baseline GI at 3-month after intervention
    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
  • gingival index (GI) — Change from Baseline GI at 6-month after intervention
    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
  • 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, 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) — 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, 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) — 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, 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) — 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. \- Page 4 of 8 - 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. \- Page 4 of 8 - 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. \- Page 4 of 8 - For each patient, CAL will measured each teeth.
  • OHRQoL(OHIP-14T scales) — Change from Baseline at 1 month after intervention
    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) — Change from Baseline at 3 month after intervention
    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) — Change from Baseline at 6 month after intervention
    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.

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 NCT06083649 on ClinicalTrials.gov ↗ ← All trials in Taiwan