Using AR Dental Care Training System in HE on Periodontal Status, Blood Sugar Control and QoL in Patients With T2DM
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05941468 |
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Recruitment Status :
Recruiting
First Posted : July 12, 2023
Last Update Posted : July 12, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus Type 2 With Periodontal Disease | Device: AR Dental Care Training System | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Prevention |
| Official Title: | 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 |
| Actual Study Start Date : | March 28, 2023 |
| Estimated Primary Completion Date : | March 27, 2024 |
| Estimated Study Completion Date : | March 27, 2024 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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. |
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No Intervention: Control group (CG)
the control group(CG) only have standard oral hygiene education
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- Gingival index (GI) [ Time Frame: Change from Baseline GI at 1-month after intervention ]
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
- Gingival index (GI) [ Time Frame: Change from Baseline GI at 3-month after intervention ]
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
- Gingival index (GI) [ Time Frame: Change from Baseline GI at 6-month after intervention ]
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
- Gingival index (GI) [ Time Frame: Change from Baseline GI at 1 year after intervention ]
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
- Plaque index (PI) [ Time Frame: Change from Baseline PI at 1-month after intervention ]
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
- Plaque index (PI) [ Time Frame: Change from Baseline PI at 3-month after intervention ]
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
- Plaque index (PI) [ Time Frame: Change from Baseline PI at 6-month after intervention ]
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
- Plaque index (PI) [ Time Frame: Change from Baseline PI at 1 year after intervention ]
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
- Probing Pocket Depth (PPD) [ Time Frame: Change from Baseline PPD at 1-month after intervention ]
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.
- Probing Pocket Depth (PPD) [ Time Frame: Change from Baseline PPD at 3-month after intervention ]
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.
- Probing Pocket Depth (PPD) [ Time Frame: Change from Baseline PPD at 6-month after intervention ]
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.
- Probing Pocket Depth (PPD) [ Time Frame: Change from Baseline PPD at 1 year after intervention ]
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.
- Clinical Attachment Loss(CAL) [ Time Frame: Change from Baseline CAL at 1-month after intervention ]
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.
- Clinical Attachment Loss(CAL) [ Time Frame: Change from Baseline CAL at 3-month after intervention ]
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.
- Clinical Attachment Loss(CAL) [ Time Frame: Change from Baseline CAL at 6-month after intervention ]
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.
- Clinical Attachment Loss(CAL) [ Time Frame: Change from Baseline CAL at 1 year after intervention ]
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.
- Plaque Control Record (PCR) [ Time Frame: Change from Baseline PCR at 1-month after intervention ]
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.
- Plaque Control Record (PCR) [ Time Frame: Change from Baseline PCR at 3-month after intervention ]
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.
- Plaque Control Record (PCR) [ Time Frame: Change from Baseline PCR at 6-month after intervention ]
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.
- Plaque Control Record (PCR) [ Time Frame: Change from Baseline PCR at 1 year after intervention ]
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.
- Oral health knowledge [ Time Frame: Change from Baseline at 1-month after intervention ]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.
- Oral health knowledge [ Time Frame: Change from Baseline at 3-month after intervention ]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.
- Oral health knowledge [ Time Frame: Change from Baseline at 6-month after intervention ]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.
- Oral health knowledge [ Time Frame: Change from Baseline at 1 year after intervention ]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.
- Attitude toward oral health [ Time Frame: Change from Baseline at 1-month after intervention ]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.
- Attitude toward oral health [ Time Frame: Change from Baseline at 3-month after intervention ]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.
- Attitude toward oral health [ Time Frame: Change from Baseline at 6-month after intervention ]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.
- Attitude toward oral health [ Time Frame: Change from Baseline at 1 year after intervention ]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.
- Oral Health Related Quality of Life(OHRQoL) [ Time Frame: Change from Baseline at 1-month after intervention ]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
- Oral Health Related Quality of Life(OHRQoL) [ Time Frame: Change from Baseline at 3-month after intervention ]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
- Oral Health Related Quality of Life(OHRQoL) [ Time Frame: Change from Baseline at 6-month after intervention ]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
- Oral Health Related Quality of Life(OHRQoL) [ Time Frame: Change from Baseline at 1 year after intervention ]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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 35 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05941468
| Taiwan | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting |
| Kaohsiung, Taiwan | |
| Contact: CHIH-CHANG CHEN, Master +886-7-3121101 ext 2159 R0990137@gmail.com | |
| Principal Investigator: | HSIAO-LING HUANG, Dr.PH | Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene |
| Responsible Party: | Kaohsiung Medical University Chung-Ho Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT05941468 |
| Other Study ID Numbers: |
KMUHIRB-F(II)-20230056 |
| First Posted: | July 12, 2023 Key Record Dates |
| Last Update Posted: | July 12, 2023 |
| Last Verified: | April 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Augmented Reality Periodontitis Blood Sugar Control Type 2 Diabetes |
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Periodontal Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Mouth Diseases Stomatognathic Diseases |