Diabetes Mellitus Type 2 With Periodontal DiseaseNCT05941468
Using AR Dental Care Training System in HE on Periodontal Status, Blood Sugar Control and QoL in Patients With T2DM
A study testing AR Dental Care Training System in people with Diabetes Mellitus Type 2 With Periodontal Disease, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2 With Periodontal Disease
- What is being tested?
- AR Dental Care Training System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Mar 2023to 27 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
CHIH-CHANG CHEN, Master, +886-7-3121101 ext. 2159, R0990137@gmail.com
About this study
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
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.
Read the 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.
- Being tested
- AR Dental Care Training System
- Keywords
- Augmented Reality, Periodontitis, Blood Sugar Control, Type 2 Diabetes
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR Dental Care Training SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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.) Receives: Device: AR Dental Care Training System |
| Control group (CG) | No intervention | the control group(CG) only have standard oral hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline PCR at 1 year after intervention
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline at 1 year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start28 Mar 2023
- Primary completion27 Mar 2024 (estimated)
- Study completion27 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 With Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HSIAO-LING HUANG, Dr.PH, Principal investigator, Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941468
- Sponsor's protocol ID
- KMUHIRB-F(II)-20230056
- Status last verified
- Apr 2023
- First submitted
- 4 Jul 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05941468
- Acronym / sponsor ID
- KMUHIRB-F(II)-20230056
- Keywords
- Augmented Reality, Periodontitis, Blood Sugar Control, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 27 Mar 2024 (estimated)
- Study completion
- 27 Mar 2024 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AR group (EG-A) | Experimental | Device: AR Dental Care Training SystemBehavioral: 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 | Device: AR Dental Care Training SystemBehavioral: 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 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR Dental Care Training SystemAR 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. | Device | AR group (EG-A), AR-health consulting group (EG-B) |
Primary outcome
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. 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
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. 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
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. 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
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. 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
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 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
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 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
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 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
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 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
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.
12 secondary outcomes
Oral health knowledge
Time frame: Change from Baseline at 1-month after intervention
Oral health knowledge
Time frame: Change from Baseline at 3-month after intervention
Oral health knowledge
Time frame: Change from Baseline at 6-month after intervention
Oral health knowledge
Time frame: Change from Baseline at 1 year after intervention
Attitude toward oral health
Time frame: Change from Baseline at 1-month after intervention
Attitude toward oral health
Time frame: Change from Baseline at 3-month after intervention
Attitude toward oral health
Time frame: Change from Baseline at 6-month after intervention
Attitude toward oral health
Time frame: Change from Baseline at 1 year after intervention
Oral Health Related Quality of Life(OHRQoL)
Time frame: Change from Baseline at 1-month after intervention
Oral Health Related Quality of Life(OHRQoL)
Time frame: Change from Baseline at 3-month after intervention
Oral Health Related Quality of Life(OHRQoL)
Time frame: Change from Baseline at 6-month after intervention
Oral Health Related Quality of Life(OHRQoL)
Time frame: Change from Baseline at 1 year after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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Diabetes Type 2, Periodontal Disease
Not yet recruiting
Clinical and Radiographic Evaluation of Subgingival 1% Metformin Gel Versus 0.05% Zoledronate Gel as an Adjunct to MINST of Intrabony Defects in Controlled Type 2 DM
Controlled Type 2 Diabetic Patients With Periodontitis
RecruitingObservational study
Salivary Apelin, Chemerin, Ghrelin, and Lipocalin-2 Levels in Diabetic Patients With Periodontitis
Periodontitis, Type 2 Diabetes Mellitus (T2DM)
Recruiting
HbA1c Screening in Dental Care and Primary Care Referral in Patients With Advanced Periodontitis
Periodontitis, Adult, Prediabetes / Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
HSIAO-LING HUANG, Dr.PH principal investigator
Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR Dental Care Training System in people with Diabetes Mellitus Type 2 With Periodontal Disease, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival index (GI) (time frame: Change from Baseline GI at 1-month after intervention). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.