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

NCT ID: NCT04567030

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-16
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Experimental group A (AI Group: EG-A)

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.

Group Type: EXPERIMENTAL

Dental monitoring (DM)

Intervention Type: 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 B (AI with humanized Group: EG-B)

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.

Group Type: EXPERIMENTAL

Dental monitoring (DM)

Intervention Type: 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.

Control group (CG)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

KANG-LING SHEN

Role: primary

kmudh108@gmail.com

+886-7-3121101 ext. 2159

References

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.

Reference Type: DERIVED

PMID: 35713224 (View on PubMed)

Other Identifiers

KMUHIRB-E(I)-20190141

Identifier Type: -

Identifier Source: org_study_id