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

NCT05941468 | Unknown

• 1 other identifier: KMUHIRB-F(II)-20230056
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus Type 2 With Periodontal Disease

Keywords

Augmented Reality; Periodontitis; Blood Sugar Control; Type 2 Diabetes

Outcome Measures

Primary Outcomes (20)

• Gingival index (GI)

  The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows: 0 = No inflammation. 1. = Mild inflammation, slight change in color, slight edema, no bleeding on probing 2. = Moderate inflammation, moderate glazing, redness, bleeding on probing 3. = 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. 1. = Mild inflammation, slight change in color, slight edema, no bleeding on probing 2. = Moderate inflammation, moderate glazing, redness, bleeding on probing 3. = 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. 1. = Mild inflammation, slight change in color, slight edema, no bleeding on probing 2. = Moderate inflammation, moderate glazing, redness, bleeding on probing 3. = 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. 1. = Mild inflammation, slight change in color, slight edema, no bleeding on probing 2. = Moderate inflammation, moderate glazing, redness, bleeding on probing 3. = 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 1. = Thin film of plaque, scraped with explorer 2. = Moderate amount of plaque, visible with naked eyes 3. = 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 1. = Thin film of plaque, scraped with explorer 2. = Moderate amount of plaque, visible with naked eyes 3. = 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 1. = Thin film of plaque, scraped with explorer 2. = Moderate amount of plaque, visible with naked eyes 3. = 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 1. = Thin film of plaque, scraped with explorer 2. = Moderate amount of plaque, visible with naked eyes 3. = 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-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

• 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-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

• 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 Outcomes (12)

• Oral health knowledge

  Change from Baseline at 1-month after intervention

• Oral health knowledge

  Change from Baseline at 3-month after intervention

• Oral health knowledge

  Change from Baseline at 6-month after intervention

• Oral health knowledge

  Change from Baseline at 1 year after intervention

• Attitude toward oral health

  Change from Baseline at 1-month after intervention

Study Arms (3)

AR group (EG-A)

EXPERIMENTAL

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-health consulting group (EG-B)

EXPERIMENTAL

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

Control group (CG)

NO INTERVENTION

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

Interventions

AR Dental Care Training System 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 group (EG-A); AR-health consulting group (EG-B)

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• HSIAO-LING HUANG, Dr.PH

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 12, 2023
• Study Start: March 28, 2023
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: July 12, 2023

Record last verified: 2023-04

Locations

TW (1)