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Recruiting NCT04567030

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

No phase Interventional Periodontal Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dental monitoring (DM).
Who it may be relevant to
Registry conditions: Periodontal Diseases. Basic parameters: 35 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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.

Interventions

  • Device 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.

Primary outcome measures

  • gingival index (GI) [Time frame: Change from Baseline GI at 1-month after intervention]
  • gingival index (GI) [Time frame: Change from Baseline GI at 3-month after intervention]
  • gingival index (GI) [Time frame: Change from Baseline GI at 6-month after intervention]
  • plaque index (PI) [Time frame: Change from Baseline PI at 1-month after intervention]
  • plaque index (PI) [Time frame: Change from Baseline PI at 3-month after intervention]
  • plaque index (PI) [Time frame: Change from Baseline PI at 6-month after intervention]
  • Probing Pocket Depth (PPD) [Time frame: Change from Baseline PPD at 1-month after intervention]
  • Probing Pocket Depth (PPD) [Time frame: Change from Baseline PPD at 3-month after intervention]
  • Probing Pocket Depth (PPD) [Time frame: Change from Baseline PPD at 6-month after intervention]
  • Clinical Attachment Loss(CAL) [Time frame: Change from Baseline CAL at 1-month after intervention]
Secondary outcome measures (6)
  • oral self-care behavior [Time frame: Change from Baseline at 1 month after intervention]
  • oral self-care behavior [Time frame: Change from Baseline at 3 month after intervention]
  • oral self-care behavior [Time frame: Change from Baseline at 6 month after intervention]
  • OHIP-14T scales [Time frame: Change from Baseline at 1 month after intervention]
  • OHIP-14T scales [Time frame: Change from Baseline at 3 month after intervention]
  • OHIP-14T scales [Time frame: Change from Baseline at 6 month after intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Taiwan · 1 center
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City

Publications

  • 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

Identifiers

NCT: NCT04567030 · KMUHIRB-E(I)-20190141

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗