Using AR Dental Care Training System in HE on Periodontal Status, Blood Sugar Control and QoL in Patients With T2DM

NCT ID: NCT05941468

Last Updated: 2023-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-28

Study Completion Date

2024-03-27

Brief Summary

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The aim of this study was to evaluate the long-term effectiveness of an AR dental care training in health education on periodontal status, blood sugar control and quality of life in patients with poorly controlled type 2 diabetes. This randomized controlled trial included experimental group: AR group (EG-A), AR-health consulting group (EG-B) and control group (CG), respectively.

The EG-A and EG-B received AR dental care training intervention 2 to 3 times during non-surgical periodontal treatment.

Baseline and follow-up surveys were used to collect the data in periodontal index, blood sugar data, oral health knowledge, attitudes, behavior, oral health-related quality of life.

Detailed Description

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A randomized experimental design was used. Patients with type 2 diabetes whose aged 35-65 years and HbA1c over 7% in the past six months were recruited through department of Endocrinology and Metabolism 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 and 1 year follow-ups.

Each patients will be diagnosed periodontal disease by dentist and have more than 12 functional teeth.

Each patients will completed the questionnaire at baseline and at 1-month, 3- month,6-month and 1 year follow-up.

Conditions

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Diabetes Mellitus Type 2 With Periodontal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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AR group (EG-A)

Behavioral: AR intervention For the EG-A, the AR dental care training system will give to patients that 2 to 3 times tooth clean skill learning course (including Bass method of brushing and inter-dental toothbrush brushing technique) during non-surgical periodontal treatment period.

Group Type EXPERIMENTAL

AR Dental Care Training System

Intervention Type DEVICE

AR dental care training system is the first training system used in tooth clean skill learning (including Bass method of brushing and inter-dental toothbrush brushing technique) the world, it has been used to training elementary school children and dental hygiene student. And we are the first study to use this system to learn oral cleaning skill in hospital for patient with T2DM.

AR-health consulting group (EG-B)

Behavioral: AR intervention For the EG-B, the AR dental care training system will give to patients that 2 to 3 times tooth clean skill learning course (including Bass method of brushing and inter-dental toothbrush brushing technique) during non-surgical periodontal treatment period.

The health counseling will also provide professional oral health related courses (including oral care for diabetes and periodontal disease, etc.)

Group Type EXPERIMENTAL

AR Dental Care Training System

Intervention Type DEVICE

AR dental care training system is the first training system used in tooth clean skill learning (including Bass method of brushing and inter-dental toothbrush brushing technique) the world, it has been used to training elementary school children and dental hygiene student. And we are the first study to use this system to learn oral cleaning skill in hospital for patient with T2DM.

Control group (CG)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AR Dental Care Training System

AR dental care training system is the first training system used in tooth clean skill learning (including Bass method of brushing and inter-dental toothbrush brushing technique) the world, it has been used to training elementary school children and dental hygiene student. And we are the first study to use this system to learn oral cleaning skill in hospital for patient with T2DM.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 35 years old (inclusive) and above
* HbA1c over 7% in the past six months
* There are more than 12 functional teeth to ensure that the patient has enough teeth to evaluate the periodontal condition

Exclusion Criteria

* Have received periodontal treatment within the previous 6 months
* Habits of smoking, drugs and betel nut chewing
* Taking antibiotics and osteoporosis bisphosphonates and other drugs regularly
* People with cognitive function or physical and mental disabilities
* Severely impaired diseases (for example: cancer, renal function or liver failure, etc.)
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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HSIAO-LING HUANG, Dr.PH

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene

Locations

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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CHIH-CHANG CHEN, Master

Role: primary

+886-7-3121101 ext. 2159

Other Identifiers

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KMUHIRB-F(II)-20230056

Identifier Type: -

Identifier Source: org_study_id

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