Clinical trial NCT06083649: The Dental Care Revolution: Health Education Using AI or Humanized Counseling on Plague Control and Periodontal Treatment Outcome in Patients With Periodontal Disease
Official title: The Dental Care Revolution: Health Education Using AI or Humanized Counseling on Plague Control and Periodontal Treatment Outcome in Patients With Periodontal Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontal Diseases
Keywords: periodontal disease
artificial intelligence (AI)
OHRQoL
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 oral health related quality of life,periodontal parameters, periodontal preventive behaviors 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.

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

Primary outcomes:
measure: gingival index (GI)
timeFrame: Change from Baseline GI at 1-month after intervention
measure: gingival index (GI)
timeFrame: Change from Baseline GI at 3-month after intervention
measure: gingival index (GI)
timeFrame: Change from Baseline GI at 6-month after intervention
measure: plaque index (PI)
timeFrame: Change from Baseline PI at 1-month after intervention
measure: plaque index (PI)
timeFrame: Change from Baseline PI at 3-month after intervention
measure: plaque index (PI)
timeFrame: Change from Baseline PI at 6-month after intervention
measure: Probing Pocket Depth (PPD)
timeFrame: Change from Baseline PPD at 1-month after intervention
measure: Probing Pocket Depth (PPD)
timeFrame: Change from Baseline PPD at 3-month after intervention
measure: Probing Pocket Depth (PPD)
timeFrame: Change from Baseline PPD at 6-month after intervention
measure: Clinical Attachment Loss(CAL)
timeFrame: Change from Baseline CAL at 1-month after intervention
measure: Clinical Attachment Loss(CAL)
timeFrame: Change from Baseline CAL at 3-month after intervention
measure: Clinical Attachment Loss(CAL)
timeFrame: Change from Baseline CAL at 6-month after intervention
measure: OHRQoL(OHIP-14T scales)
timeFrame: Change from Baseline at 1 month after intervention
measure: OHRQoL(OHIP-14T scales)
timeFrame: Change from Baseline at 3 month after intervention
measure: OHRQoL(OHIP-14T scales)
timeFrame: Change from Baseline at 6 month after intervention
Secondary outcomes:
measure: Protection Motivation Theory (PMT) scores
timeFrame: Change from Baseline PMT at 1-month after intervention
measure: Protection Motivation Theory (PMT) scores
timeFrame: Change from Baseline PMT at 3-month after intervention
measure: Protection Motivation Theory (PMT) scores
timeFrame: Change from Baseline PMT at 6-month after intervention
measure: oral self-care behavior
timeFrame: Change from Baseline at 1 month after intervention
measure: oral self-care behavior
timeFrame: Change from Baseline at 3 month after intervention
measure: oral self-care behavior
timeFrame: Change from Baseline at 6 month after intervention
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene
name: Hsiao-Ling Huang, Dr.PH
role: PRINCIPAL_INVESTIGATOR
References: