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

Primary Purpose

Diabetes Mellitus Type 2 With Periodontal Disease

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
AR Dental Care Training System
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus Type 2 With Periodontal Disease focused on measuring Augmented Reality, Periodontitis, Blood Sugar Control, Type 2 Diabetes

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

AR group (EG-A)

AR-health consulting group (EG-B)

Control group (CG)

Arm Description

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.

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.)

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

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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

Full Information

First Posted
July 4, 2023
Last Updated
July 4, 2023
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05941468
Brief Title
Using AR Dental Care Training System in HE on Periodontal Status, Blood Sugar Control and QoL in Patients With T2DM
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
March 27, 2024 (Anticipated)
Study Completion Date
March 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2 With Periodontal Disease
Keywords
Augmented Reality, Periodontitis, Blood Sugar Control, Type 2 Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AR group (EG-A)
Arm Type
Experimental
Arm Description
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.
Arm Title
AR-health consulting group (EG-B)
Arm Type
Experimental
Arm Description
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.)
Arm Title
Control group (CG)
Arm Type
No Intervention
Arm Description
the control group(CG) only have standard oral hygiene education
Intervention Type
Device
Intervention Name(s)
AR Dental Care Training System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gingival index (GI)
Description
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
Time Frame
Change from Baseline GI at 1-month after intervention
Title
Gingival index (GI)
Description
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
Time Frame
Change from Baseline GI at 3-month after intervention
Title
Gingival index (GI)
Description
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
Time Frame
Change from Baseline GI at 6-month after intervention
Title
Gingival index (GI)
Description
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
Time Frame
Change from Baseline GI at 1 year after intervention
Title
Plaque index (PI)
Description
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
Time Frame
Change from Baseline PI at 1-month after intervention
Title
Plaque index (PI)
Description
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
Time Frame
Change from Baseline PI at 3-month after intervention
Title
Plaque index (PI)
Description
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
Time Frame
Change from Baseline PI at 6-month after intervention
Title
Plaque index (PI)
Description
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
Time Frame
Change from Baseline PI at 1 year after intervention
Title
Probing Pocket Depth (PPD)
Description
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.
Time Frame
Change from Baseline PPD at 1-month after intervention
Title
Probing Pocket Depth (PPD)
Description
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.
Time Frame
Change from Baseline PPD at 3-month after intervention
Title
Probing Pocket Depth (PPD)
Description
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.
Time Frame
Change from Baseline PPD at 6-month after intervention
Title
Probing Pocket Depth (PPD)
Description
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.
Time Frame
Change from Baseline PPD at 1 year after intervention
Title
Clinical Attachment Loss(CAL)
Description
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.
Time Frame
Change from Baseline CAL at 1-month after intervention
Title
Clinical Attachment Loss(CAL)
Description
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.
Time Frame
Change from Baseline CAL at 3-month after intervention
Title
Clinical Attachment Loss(CAL)
Description
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.
Time Frame
Change from Baseline CAL at 6-month after intervention
Title
Clinical Attachment Loss(CAL)
Description
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.
Time Frame
Change from Baseline CAL at 1 year after intervention
Title
Plaque Control Record (PCR)
Description
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.
Time Frame
Change from Baseline PCR at 1-month after intervention
Title
Plaque Control Record (PCR)
Description
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.
Time Frame
Change from Baseline PCR at 3-month after intervention
Title
Plaque Control Record (PCR)
Description
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.
Time Frame
Change from Baseline PCR at 6-month after intervention
Title
Plaque Control Record (PCR)
Description
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.
Time Frame
Change from Baseline PCR at 1 year after intervention
Secondary Outcome Measure Information:
Title
Oral health knowledge
Description
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.
Time Frame
Change from Baseline at 1-month after intervention
Title
Oral health knowledge
Description
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.
Time Frame
Change from Baseline at 3-month after intervention
Title
Oral health knowledge
Description
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.
Time Frame
Change from Baseline at 6-month after intervention
Title
Oral health knowledge
Description
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.
Time Frame
Change from Baseline at 1 year after intervention
Title
Attitude toward oral health
Description
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.
Time Frame
Change from Baseline at 1-month after intervention
Title
Attitude toward oral health
Description
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.
Time Frame
Change from Baseline at 3-month after intervention
Title
Attitude toward oral health
Description
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.
Time Frame
Change from Baseline at 6-month after intervention
Title
Attitude toward oral health
Description
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.
Time Frame
Change from Baseline at 1 year after intervention
Title
Oral Health Related Quality of Life(OHRQoL)
Description
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
Time Frame
Change from Baseline at 1-month after intervention
Title
Oral Health Related Quality of Life(OHRQoL)
Description
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
Time Frame
Change from Baseline at 3-month after intervention
Title
Oral Health Related Quality of Life(OHRQoL)
Description
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
Time Frame
Change from Baseline at 6-month after intervention
Title
Oral Health Related Quality of Life(OHRQoL)
Description
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
Time Frame
Change from Baseline at 1 year after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HSIAO-LING HUANG, Dr.PH
Organizational Affiliation
Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHIH-CHANG CHEN, Master
Phone
+886-7-3121101
Ext
2159
Email
R0990137@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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