Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT05941468
Status:
UNKNOWN
Last Update Posted:
2023-07-12
First Post:
2023-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using AR Dental Care Training System in HE on Periodontal Status, Blood Sugar Control and QoL in Patients With T2DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-03-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-04', 'studyFirstSubmitDate': '2023-07-04', 'studyFirstSubmitQcDate': '2023-07-04', 'lastUpdatePostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival index (GI)', 'timeFrame': 'Change from Baseline GI at 1-month after intervention', 'description': 'The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows:\n\n0 = No inflammation.\n\n1. = Mild inflammation, slight change in color, slight edema, no bleeding on probing\n2. = Moderate inflammation, moderate glazing, redness, bleeding on probing\n3. = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.\n\nFor each patient, GI will measured by the teeth 12,16,24,32,36,44'}, {'measure': 'Gingival index (GI)', 'timeFrame': 'Change from Baseline GI at 3-month after intervention', 'description': 'The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows:\n\n0 = No inflammation.\n\n1. = Mild inflammation, slight change in color, slight edema, no bleeding on probing\n2. = Moderate inflammation, moderate glazing, redness, bleeding on probing\n3. = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.\n\nFor each patient, GI will measured by the teeth 12,16,24,32,36,44'}, {'measure': 'Gingival index (GI)', 'timeFrame': 'Change from Baseline GI at 6-month after intervention', 'description': 'The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows:\n\n0 = No inflammation.\n\n1. = Mild inflammation, slight change in color, slight edema, no bleeding on probing\n2. = Moderate inflammation, moderate glazing, redness, bleeding on probing\n3. = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.\n\nFor each patient, GI will measured by the teeth 12,16,24,32,36,44'}, {'measure': 'Gingival index (GI)', 'timeFrame': 'Change from Baseline GI at 1 year after intervention', 'description': 'The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows:\n\n0 = No inflammation.\n\n1. = Mild inflammation, slight change in color, slight edema, no bleeding on probing\n2. = Moderate inflammation, moderate glazing, redness, bleeding on probing\n3. = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.\n\nFor each patient, GI will measured by the teeth 12,16,24,32,36,44'}, {'measure': 'Plaque index (PI)', 'timeFrame': 'Change from Baseline PI at 1-month after intervention', 'description': 'The plaque status of 6 tooth was recorded using the plaque index, as followes:\n\n0 = No plaque\n\n1. = Thin film of plaque, scraped with explorer\n2. = Moderate amount of plaque, visible with naked eyes\n3. = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.\n\nFor each patient, PI will measured by the teeth 12,16,24,32,36,44'}, {'measure': 'Plaque index (PI)', 'timeFrame': 'Change from Baseline PI at 3-month after intervention', 'description': 'The plaque status of 6 tooth was recorded using the plaque index, as followes:\n\n0 = No plaque\n\n1. = Thin film of plaque, scraped with explorer\n2. = Moderate amount of plaque, visible with naked eyes\n3. = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.\n\nFor each patient, PI will measured by the teeth 12,16,24,32,36,44'}, {'measure': 'Plaque index (PI)', 'timeFrame': 'Change from Baseline PI at 6-month after intervention', 'description': 'The plaque status of 6 tooth was recorded using the plaque index, as followes:\n\n0 = No plaque\n\n1. = Thin film of plaque, scraped with explorer\n2. = Moderate amount of plaque, visible with naked eyes\n3. = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.\n\nFor each patient, PI will measured by the teeth 12,16,24,32,36,44'}, {'measure': 'Plaque index (PI)', 'timeFrame': 'Change from Baseline PI at 1 year after intervention', 'description': 'The plaque status of 6 tooth was recorded using the plaque index, as followes:\n\n0 = No plaque\n\n1. = Thin film of plaque, scraped with explorer\n2. = Moderate amount of plaque, visible with naked eyes\n3. = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.\n\nFor each patient, PI will measured by the teeth 12,16,24,32,36,44'}, {'measure': 'Probing Pocket Depth (PPD)', 'timeFrame': 'Change from Baseline PPD at 1-month after intervention', 'description': 'Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin.\n\nFor each patient, PPD will measured each teeth.'}, {'measure': 'Probing Pocket Depth (PPD)', 'timeFrame': 'Change from Baseline PPD at 3-month after intervention', 'description': 'Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin.\n\nFor each patient, PPD will measured each teeth.'}, {'measure': 'Probing Pocket Depth (PPD)', 'timeFrame': 'Change from Baseline PPD at 6-month after intervention', 'description': 'Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin.\n\nFor each patient, PPD will measured each teeth.'}, {'measure': 'Probing Pocket Depth (PPD)', 'timeFrame': 'Change from Baseline PPD at 1 year after intervention', 'description': 'Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin.\n\nFor each patient, PPD will measured each teeth.'}, {'measure': 'Clinical Attachment Loss(CAL)', 'timeFrame': 'Change from Baseline CAL at 1-month after intervention', 'description': 'Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket.\n\nFor each patient, CAL will measured each teeth.'}, {'measure': 'Clinical Attachment Loss(CAL)', 'timeFrame': 'Change from Baseline CAL at 3-month after intervention', 'description': 'Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket.\n\nFor each patient, CAL will measured each teeth.'}, {'measure': 'Clinical Attachment Loss(CAL)', 'timeFrame': 'Change from Baseline CAL at 6-month after intervention', 'description': 'Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket.\n\nFor each patient, CAL will measured each teeth.'}, {'measure': 'Clinical Attachment Loss(CAL)', 'timeFrame': 'Change from Baseline CAL at 1 year after intervention', 'description': 'Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket.\n\nFor each patient, CAL will measured each teeth.'}, {'measure': 'Plaque Control Record (PCR)', 'timeFrame': 'Change from Baseline PCR at 1-month after intervention', '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).\n\nFor each patient, PCR will measured each teeth.'}, {'measure': 'Plaque Control Record (PCR)', 'timeFrame': 'Change from Baseline PCR at 3-month after intervention', '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).\n\nFor each patient, PCR will measured each teeth.'}, {'measure': 'Plaque Control Record (PCR)', 'timeFrame': 'Change from Baseline PCR at 6-month after intervention', '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).\n\nFor each patient, PCR will measured each teeth.'}, {'measure': 'Plaque Control Record (PCR)', 'timeFrame': 'Change from Baseline PCR at 1 year after intervention', '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).\n\nFor each patient, PCR will measured each teeth.'}], 'secondaryOutcomes': [{'measure': 'Oral health knowledge', 'timeFrame': 'Change from Baseline at 1-month after intervention', '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.'}, {'measure': 'Oral health knowledge', 'timeFrame': 'Change from Baseline at 3-month after intervention', '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.'}, {'measure': 'Oral health knowledge', 'timeFrame': 'Change from Baseline at 6-month after intervention', '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.'}, {'measure': 'Oral health knowledge', 'timeFrame': 'Change from Baseline at 1 year after intervention', '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.'}, {'measure': 'Attitude toward oral health', 'timeFrame': 'Change from Baseline at 1-month after intervention', '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."}, {'measure': 'Attitude toward oral health', 'timeFrame': 'Change from Baseline at 3-month after intervention', '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."}, {'measure': 'Attitude toward oral health', 'timeFrame': 'Change from Baseline at 6-month after intervention', '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."}, {'measure': 'Attitude toward oral health', 'timeFrame': 'Change from Baseline at 1 year after intervention', '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."}, {'measure': 'Oral Health Related Quality of Life(OHRQoL)', 'timeFrame': 'Change from Baseline at 1-month after intervention', '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'}, {'measure': 'Oral Health Related Quality of Life(OHRQoL)', 'timeFrame': 'Change from Baseline at 3-month after intervention', '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'}, {'measure': 'Oral Health Related Quality of Life(OHRQoL)', 'timeFrame': 'Change from Baseline at 6-month after intervention', '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'}, {'measure': 'Oral Health Related Quality of Life(OHRQoL)', 'timeFrame': 'Change from Baseline at 1 year after intervention', '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Augmented Reality', 'Periodontitis', 'Blood Sugar Control', 'Type 2 Diabetes'], 'conditions': ['Diabetes Mellitus Type 2 With Periodontal Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nThe EG-A and EG-B received AR dental care training intervention 2 to 3 times during non-surgical periodontal treatment.\n\nBaseline 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.', 'detailedDescription': '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.\n\nEach 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.\n\nAll patients will underwent periodontal examination at baseline and at 1-month, 3-month, 6-month and 1 year follow-ups.\n\nEach patients will be diagnosed periodontal disease by dentist and have more than 12 functional teeth.\n\nEach patients will completed the questionnaire at baseline and at 1-month, 3- month,6-month and 1 year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 35 years old (inclusive) and above\n* HbA1c over 7% in the past six months\n* There are more than 12 functional teeth to ensure that the patient has enough teeth to evaluate the periodontal condition\n\nExclusion Criteria:\n\n* Have received periodontal treatment within the previous 6 months\n* Habits of smoking, drugs and betel nut chewing\n* Taking antibiotics and osteoporosis bisphosphonates and other drugs regularly\n* People with cognitive function or physical and mental disabilities\n* Severely impaired diseases (for example: cancer, renal function or liver failure, etc.)'}, 'identificationModule': {'nctId': 'NCT05941468', 'briefTitle': 'Using AR Dental Care Training System in HE on Periodontal Status, Blood Sugar Control and QoL in Patients With T2DM', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'KMUHIRB-F(II)-20230056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AR group (EG-A)', '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.', 'interventionNames': ['Device: AR Dental Care Training System']}, {'type': 'EXPERIMENTAL', 'label': 'AR-health consulting group (EG-B)', '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.\n\nThe health counseling will also provide professional oral health related courses (including oral care for diabetes and periodontal disease, etc.)', 'interventionNames': ['Device: AR Dental Care Training System']}, {'type': 'NO_INTERVENTION', 'label': 'Control group (CG)', 'description': 'the control group(CG) only have standard oral hygiene education'}], 'interventions': [{'name': 'AR Dental Care Training System', 'type': 'DEVICE', '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.', 'armGroupLabels': ['AR group (EG-A)', 'AR-health consulting group (EG-B)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'CHIH-CHANG CHEN, Master', 'role': 'CONTACT', 'email': 'R0990137@gmail.com', 'phone': '+886-7-3121101', 'phoneExt': '2159'}], 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'HSIAO-LING HUANG, Dr.PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}