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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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.) |
|
| Control group (CG) | No Intervention | the control group(CG) only have standard oral hygiene education |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival index (GI) | The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows: 0 = No inflammation.
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.
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.
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.
For each patient, GI will measured by the teeth 12,16,24,32,36,44 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HSIAO-LING HUANG, Dr.PH | Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | Taiwan |
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| 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
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
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
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
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 |
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 |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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