Using AR Dental Care Training on Periodontal Status, Blood Sugar Control and QoL in Patients With Type 2 Diabetes

Chimei Medical Center

Status: Enrolling

Conditions: Diabetes Mellitus Type 2 With Periodontal Disease

Treatments: Device: AR Dental Care Training System

Study type: Interventional

Funder types: Other

Identifiers

NCT05993741

11111-011

Details and patient eligibility

About

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-AR), AR health consulting group (EG-ARHC) and control group (CG), respectively. The EG-AR and EG-ARHC 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.

Full description

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 Chimei Hospital Yongkang and Liuying Campus.

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-ups.

Enrollment: 100 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups

AR group (EG-AR)

Experimental group

Description:

Behavioral: AR intervention For the EG-AR, 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.

Treatment:

Device: AR Dental Care Training System

AR-health consulting group (EG-ARHC)

Experimental group

Description:

AR intervention For the EG-B, the ARHC 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.)

Treatment:

Device: AR Dental Care Training System

Control group (CG)

No Intervention group

Description:

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