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

Using Augmented Reality Dental Care Training in Health Education on Periodontal Status, Blood Sugar Control and Quality of Life in Patients With Poorly Controlled Type 2 Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus Type 2 With Periodontal Disease
• Intervention / Treatment: Device: AR Dental Care Training System

Detailed 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
    • Contact: CHIH-CHANG CHEN, Master; Phone Number: 2159 +886-7-3121101; Email: R0990137@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group (CG); the control group(CG) only have standard oral hygiene education
Experimental: 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.	Device: 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.
Experimental: 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.)	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Pocket Depth (PPD)	Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin. For each patient, PPD will measured each teeth.	Change from Baseline PPD at 1-month after intervention
Probing Pocket Depth (PPD)	Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin. For each patient, PPD will measured each teeth.	Change from Baseline PPD at 3-month after intervention
Probing Pocket Depth (PPD)	Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin. For each patient, PPD will measured each teeth.	Change from Baseline PPD at 6-month after intervention
Clinical Attachment Loss(CAL)	Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket. For each patient, CAL will measured each teeth.	Change from Baseline CAL at 1-month after intervention
Clinical Attachment Loss(CAL)	Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket. For each patient, CAL will measured each teeth.	Change from Baseline CAL at 3-month after intervention
Clinical Attachment Loss(CAL)	Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket. For each patient, CAL will measured each teeth.	Change from Baseline CAL at 6-month after intervention
Gingival index (GI)	The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows: 0 = No inflammation.; = Mild inflammation, slight change in color, slight edema, no bleeding on probing; = Moderate inflammation, moderate glazing, redness, bleeding on probing; = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding. For each patient, GI will measured by the teeth 12,16,24,32,36,44	Change from Baseline GI at 1-month after intervention
Gingival index (GI)	The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows: 0 = No inflammation.; = Mild inflammation, slight change in color, slight edema, no bleeding on probing; = Moderate inflammation, moderate glazing, redness, bleeding on probing; = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding. For each patient, GI will measured by the teeth 12,16,24,32,36,44	Change from Baseline GI at 3-month after intervention
Gingival index (GI)	The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows: 0 = No inflammation.; = Mild inflammation, slight change in color, slight edema, no bleeding on probing; = Moderate inflammation, moderate glazing, redness, bleeding on probing; = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding. For each patient, GI will measured by the teeth 12,16,24,32,36,44	Change from Baseline GI at 6-month after intervention
Gingival index (GI)	The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows: 0 = No inflammation.; = Mild inflammation, slight change in color, slight edema, no bleeding on probing; = Moderate inflammation, moderate glazing, redness, bleeding on probing; = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding. For each patient, GI will measured by the teeth 12,16,24,32,36,44	Change from Baseline GI at 1 year after intervention
Plaque index (PI)	The plaque status of 6 tooth was recorded using the plaque index, as followes: 0 = No plaque; = Thin film of plaque, scraped with explorer; = Moderate amount of plaque, visible with naked eyes; = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. For each patient, PI will measured by the teeth 12,16,24,32,36,44	Change from Baseline PI at 1-month after intervention
Plaque index (PI)	The plaque status of 6 tooth was recorded using the plaque index, as followes: 0 = No plaque; = Thin film of plaque, scraped with explorer; = Moderate amount of plaque, visible with naked eyes; = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. For each patient, PI will measured by the teeth 12,16,24,32,36,44	Change from Baseline PI at 3-month after intervention
Plaque index (PI)	The plaque status of 6 tooth was recorded using the plaque index, as followes: 0 = No plaque; = Thin film of plaque, scraped with explorer; = Moderate amount of plaque, visible with naked eyes; = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. For each patient, PI will measured by the teeth 12,16,24,32,36,44	Change from Baseline PI at 6-month after intervention
Plaque index (PI)	The plaque status of 6 tooth was recorded using the plaque index, as followes: 0 = No plaque; = Thin film of plaque, scraped with explorer; = Moderate amount of plaque, visible with naked eyes; = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. For each patient, PI will measured by the teeth 12,16,24,32,36,44	Change from Baseline PI at 1 year after intervention
Probing Pocket Depth (PPD)	Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin. For each patient, PPD will measured each teeth.	Change from Baseline PPD at 1 year after intervention
Clinical Attachment Loss(CAL)	Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket. For each patient, CAL will measured each teeth.	Change from Baseline CAL at 1 year after intervention
Plaque Control Record (PCR)	The Plaque Control Record is a very simple percentage or score of the total amount of bacteria present in your mouth. A tooth has 6 surfaces at the gum line being; the lingual side (distal, middle, mesial) and buccal side (distal, middle, mesial). For each patient, PCR will measured each teeth.	Change from Baseline PCR at 1-month after intervention
Plaque Control Record (PCR)	The Plaque Control Record is a very simple percentage or score of the total amount of bacteria present in your mouth. A tooth has 6 surfaces at the gum line being; the lingual side (distal, middle, mesial) and buccal side (distal, middle, mesial). For each patient, PCR will measured each teeth.	Change from Baseline PCR at 3-month after intervention
Plaque Control Record (PCR)	The Plaque Control Record is a very simple percentage or score of the total amount of bacteria present in your mouth. A tooth has 6 surfaces at the gum line being; the lingual side (distal, middle, mesial) and buccal side (distal, middle, mesial). For each patient, PCR will measured each teeth.	Change from Baseline PCR at 6-month after intervention
Plaque Control Record (PCR)	The Plaque Control Record is a very simple percentage or score of the total amount of bacteria present in your mouth. A tooth has 6 surfaces at the gum line being; the lingual side (distal, middle, mesial) and buccal side (distal, middle, mesial). For each patient, PCR will measured each teeth.	Change from Baseline PCR at 1 year after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral health knowledge	The oral health knowledge is a questionnaire scale. Total of 12 items ex. Are diabetic patients more likely to have periodontal disease? score range is 0 to 12, higher score means have the better the oral health knowledge.	Change from Baseline at 1-month after intervention
Oral health knowledge	The oral health knowledge is a questionnaire scale. Total of 12 items ex. Are diabetic patients more likely to have periodontal disease? score range is 0 to 12, higher score means have the better the oral health knowledge.	Change from Baseline at 3-month after intervention
Oral health knowledge	The oral health knowledge is a questionnaire scale. Total of 12 items ex. Are diabetic patients more likely to have periodontal disease? score range is 0 to 12, higher score means have the better the oral health knowledge.	Change from Baseline at 6-month after intervention
Oral health knowledge	The oral health knowledge is a questionnaire scale. Total of 12 items ex. Are diabetic patients more likely to have periodontal disease? score range is 0 to 12, higher score means have the better the oral health knowledge.	Change from Baseline at 1 year after intervention
Attitude toward oral health	The attitude toward oral health is a questionnaire scale. Total of 7 items ex. It's normal for older people to lose their teeth. score range is 7 to 35, higher score means have more positive attitude toward oral health.	Change from Baseline at 1-month after intervention
Attitude toward oral health	The attitude toward oral health is a questionnaire scale. Total of 7 items ex. It's normal for older people to lose their teeth. score range is 7 to 35, higher score means have more positive attitude toward oral health.	Change from Baseline at 3-month after intervention
Attitude toward oral health	The attitude toward oral health is a questionnaire scale. Total of 7 items ex. It's normal for older people to lose their teeth. score range is 7 to 35, higher score means have more positive attitude toward oral health.	Change from Baseline at 6-month after intervention
Attitude toward oral health	The attitude toward oral health is a questionnaire scale. Total of 7 items ex. It's normal for older people to lose their teeth. score range is 7 to 35, higher score means have more positive attitude toward oral health.	Change from Baseline at 1 year after intervention
Oral Health Related Quality of Life(OHRQoL)	The OHRQoL is a questionnaire scale. Total of 14 items 7 dimensions including functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability and handicaps score range is 0-56 points, the lower the score, the greater the OHRQoL	Change from Baseline at 1-month after intervention
Oral Health Related Quality of Life(OHRQoL)	The OHRQoL is a questionnaire scale. Total of 14 items 7 dimensions including functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability and handicaps score range is 0-56 points, the lower the score, the greater the OHRQoL	Change from Baseline at 3-month after intervention
Oral Health Related Quality of Life(OHRQoL)	The OHRQoL is a questionnaire scale. Total of 14 items 7 dimensions including functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability and handicaps score range is 0-56 points, the lower the score, the greater the OHRQoL	Change from Baseline at 6-month after intervention
Oral Health Related Quality of Life(OHRQoL)	The OHRQoL is a questionnaire scale. Total of 14 items 7 dimensions including functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability and handicaps score range is 0-56 points, the lower the score, the greater the OHRQoL	Change from Baseline at 1 year after intervention

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: HSIAO-LING HUANG, Dr.PH, Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): March 27, 2024
• Study Completion (Estimated): March 27, 2024

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Periodontitis; Augmented Reality; Blood Sugar Control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Stomatognathic Diseases; Mouth Diseases; Diabetes Mellitus, Type 2; Periodontal Diseases
• Other Study ID Numbers: KMUHIRB-F(II)-20230056

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No