xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05993741</url>
    </required_header>
    <id_info>
      <org_study_id>11111-011</org_study_id>
      <nct_id>NCT05993741</nct_id>
    </id_info>
    <brief_title>Using AR Dental Care Training on Periodontal Status, Blood Sugar Control and QoL in Patients With Type 2 Diabetes</brief_title>
    <official_title>Augmented Reality(AR) Training System on Periodontal Health, Blood Sugar Control and Quality of Life in Patients With T2DM</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chimei Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Kaohsiung Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Chimei Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study was to evaluate the long-term effectiveness of an AR dental care&#xD;
        training in health education on periodontal status, blood sugar control and quality of life&#xD;
        in patients with poorly controlled type 2 diabetes. This randomized controlled trial included&#xD;
        experimental group: AR group (EG-AR), AR health consulting group (EG-ARHC) and control group&#xD;
        (CG), respectively. The EG-AR and EG-ARHC received AR dental care training intervention 2 to&#xD;
        3 times during non-surgical periodontal treatment. Baseline and follow-up surveys were used&#xD;
        to collect the data in periodontal index, blood sugar data, oral health knowledge, attitudes,&#xD;
        behavior, oral health related quality of life.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A randomized experimental design was used. Patients with type 2 diabetes whose aged 35-65&#xD;
        years and HbA1c over 7% in the past six months were recruited through department of&#xD;
        Endocrinology and Metabolism in Chimei Hospital Yongkang and Liuying Campus.&#xD;
  &#xD;
        Each group was expected for 100 per group, patients will be randomized into each group.&#xD;
        G*Power (version 3.1.9.4) was used for power analysis. All patients will underwent&#xD;
        periodontal examination at baseline and at 1-month, 3-month, 6-month and 1-year follow-ups.&#xD;
        Each patients will be diagnosed periodontal disease by dentist and have more than 12&#xD;
        functional teeth. Each patients will completed the questionnaire at baseline and at 1-month,&#xD;
        3- month, 6-month and 1-year follow-ups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Gingival index (GI)</measure>
      <time_frame>Change from Baseline GI at 1-month after intervention</time_frame>
      <description>The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows:&#xD;
  0 = No inflammation.&#xD;
  = Mild inflammation, slight change in color, slight edema, no bleeding on probing&#xD;
  = Moderate inflammation, moderate glazing, redness, bleeding on probing&#xD;
  = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.&#xD;
  For each patient, GI will measured by the teeth 12,16,24,32,36,44</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gingival index (GI)</measure>
      <time_frame>Change from Baseline GI at 3-month after intervention</time_frame>
      <description>The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows:&#xD;
  0 = No inflammation.&#xD;
  = Mild inflammation, slight change in color, slight edema, no bleeding on probing&#xD;
  = Moderate inflammation, moderate glazing, redness, bleeding on probing&#xD;
  = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.&#xD;
  For each patient, GI will measured by the teeth 12,16,24,32,36,44</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gingival index (GI)</measure>
      <time_frame>Change from Baseline GI at 6-month after intervention</time_frame>
      <description>The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows:&#xD;
  0 = No inflammation.&#xD;
  = Mild inflammation, slight change in color, slight edema, no bleeding on probing&#xD;
  = Moderate inflammation, moderate glazing, redness, bleeding on probing&#xD;
  = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.&#xD;
  For each patient, GI will measured by the teeth 12,16,24,32,36,44</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gingival index (GI)</measure>
      <time_frame>Change from Baseline GI at 1-year after intervention</time_frame>
      <description>The gingiva inflammation status of 6 tooth was recorded using the gingiva index, as follows:&#xD;
  0 = No inflammation.&#xD;
  = Mild inflammation, slight change in color, slight edema, no bleeding on probing&#xD;
  = Moderate inflammation, moderate glazing, redness, bleeding on probing&#xD;
  = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.&#xD;
  For each patient, GI will measured by the teeth 12,16,24,32,36,44</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plaque index (PI)</measure>
      <time_frame>Change from Baseline PI at 1-month after intervention</time_frame>
      <description>The plaque status of 6 tooth was recorded using the plaque index, as followes:&#xD;
  0 = No plaque&#xD;
  = Thin film of plaque, scraped with explorer&#xD;
  = Moderate amount of plaque, visible with naked eyes&#xD;
  = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.&#xD;
  For each patient, PI will measured by the teeth 12,16,24,32,36,44</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plaque index (PI)</measure>
      <time_frame>Change from Baseline PI at 3-month after intervention</time_frame>
      <description>The plaque status of 6 tooth was recorded using the plaque index, as followes:&#xD;
  0 = No plaque&#xD;
  = Thin film of plaque, scraped with explorer&#xD;
  = Moderate amount of plaque, visible with naked eyes&#xD;
  = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.&#xD;
  For each patient, PI will measured by the teeth 12,16,24,32,36,44</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plaque index (PI)</measure>
      <time_frame>Change from Baseline PI at 6-month after intervention</time_frame>
      <description>The plaque status of 6 tooth was recorded using the plaque index, as followes:&#xD;
  0 = No plaque&#xD;
  = Thin film of plaque, scraped with explorer&#xD;
  = Moderate amount of plaque, visible with naked eyes&#xD;
  = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.&#xD;
  For each patient, PI will measured by the teeth 12,16,24,32,36,44</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plaque index (PI)</measure>
      <time_frame>Change from Baseline PI at 1-year after intervention</time_frame>
      <description>The plaque status of 6 tooth was recorded using the plaque index, as followes:&#xD;
  0 = No plaque&#xD;
  = Thin film of plaque, scraped with explorer&#xD;
  = Moderate amount of plaque, visible with naked eyes&#xD;
  = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.&#xD;
  For each patient, PI will measured by the teeth 12,16,24,32,36,44</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Probing Pocket Depth (PPD)</measure>
      <time_frame>Change from Baseline PPD at 1-month after intervention</time_frame>
      <description>Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin.&#xD;
  For each patient, PPD will measured each teeth.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Probing Pocket Depth (PPD)</measure>
      <time_frame>Change from Baseline PPD at 3-month after intervention</time_frame>
      <description>Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin.&#xD;
  For each patient, PPD will measured each teeth.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Probing Pocket Depth (PPD)</measure>
      <time_frame>Change from Baseline PPD at 6-month after intervention</time_frame>
      <description>Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin.&#xD;
  For each patient, PPD will measured each teeth.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Probing Pocket Depth (PPD)</measure>
      <time_frame>Change from Baseline PPD at 1-year after intervention</time_frame>
      <description>Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin.&#xD;
  For each patient, PPD will measured each teeth.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Attachment Loss(CAL)</measure>
      <time_frame>Change from Baseline CAL at 1-month after intervention</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Attachment Loss(CAL)</measure>
      <time_frame>Change from Baseline CAL at 3-month after intervention</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Attachment Loss(CAL)</measure>
      <time_frame>Change from Baseline CAL at 6-month after intervention</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Attachment Loss(CAL)</measure>
      <time_frame>Change from Baseline CAL at 1-year after intervention</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plaque Control Record (PCR)</measure>
      <time_frame>Change from Baseline PCR at 1-month after intervention</time_frame>
      <description>The Plaque Control Record is a very simple percentage or score of the total amount of bacteria present in your mouth.&#xD;
  A tooth has 6 surfaces at the gum line being; the lingual side (distal, middle, mesial) and buccal side (distal, middle, mesial).&#xD;
  For each patient, PCR will measured each teeth.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plaque Control Record (PCR)</measure>
      <time_frame>Change from Baseline PCR at 3-month after intervention</time_frame>
      <description>The Plaque Control Record is a very simple percentage or score of the total amount of bacteria present in your mouth.&#xD;
  A tooth has 6 surfaces at the gum line being; the lingual side (distal, middle, mesial) and buccal side (distal, middle, mesial).&#xD;
  For each patient, PCR will measured each teeth.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plaque Control Record (PCR)</measure>
      <time_frame>Change from Baseline PCR at 6-month after intervention</time_frame>
      <description>The Plaque Control Record is a very simple percentage or score of the total amount of bacteria present in your mouth.&#xD;
  A tooth has 6 surfaces at the gum line being; the lingual side (distal, middle, mesial) and buccal side (distal, middle, mesial).&#xD;
  For each patient, PCR will measured each teeth.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plaque Control Record (PCR)</measure>
      <time_frame>Change from Baseline PCR at 1-year after intervention</time_frame>
      <description>The Plaque Control Record is a very simple percentage or score of the total amount of bacteria present in your mouth.&#xD;
  A tooth has 6 surfaces at the gum line being; the lingual side (distal, middle, mesial) and buccal side (distal, middle, mesial).&#xD;
  For each patient, PCR will measured each teeth.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Oral health knowledge</measure>
      <time_frame>Change from Baseline at 1-month after intervention</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral health knowledge</measure>
      <time_frame>Change from Baseline at 3-month after intervention</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral health knowledge</measure>
      <time_frame>Change from Baseline at 6-month after intervention</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral health knowledge</measure>
      <time_frame>Change from Baseline at 1-year after intervention</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Attitude toward oral health</measure>
      <time_frame>Change from Baseline at 1-month after intervention</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Attitude toward oral health</measure>
      <time_frame>Change from Baseline at 3-month after intervention</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Attitude toward oral health</measure>
      <time_frame>Change from Baseline at 6-month after intervention</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Attitude toward oral health</measure>
      <time_frame>Change from Baseline at 1-year after intervention</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral Health Related Quality of Life(OHRQoL)</measure>
      <time_frame>Change from Baseline at 1-month after intervention</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral Health Related Quality of Life(OHRQoL)</measure>
      <time_frame>Change from Baseline at 3-month after intervention</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral Health Related Quality of Life(OHRQoL)</measure>
      <time_frame>Change from Baseline at 6-month after intervention</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral Health Related Quality of Life(OHRQoL)</measure>
      <time_frame>Change from Baseline at 1-year after intervention</time_frame>
      <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</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Diabetes Mellitus Type 2 With Periodontal Disease</condition>
    <arm_group>
      <arm_group_label>AR group (EG-AR)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Behavioral: AR intervention For the EG-AR, 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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AR-health consulting group (EG-ARHC)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>AR intervention For the EG-B, the ARHC 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.&#xD;
  The health counseling will also provide professional oral health related courses (including oral care for diabetes and periodontal disease, etc.)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group (CG)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>the control group(CG) only have standard oral hygiene education</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>AR Dental Care Training System</intervention_name>
      <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.</description>
      <arm_group_label>AR group (EG-AR)</arm_group_label>
      <arm_group_label>AR-health consulting group (EG-ARHC)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 35 years old (inclusive) and above&#xD;
  &#xD;
            -  HbA1c over 7% in the past six months&#xD;
  &#xD;
            -  There are more than 12 functional teeth to ensure that the patient has enough teeth to&#xD;
               evaluate the periodontal condition&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have received periodontal treatment within the previous 6 months&#xD;
  &#xD;
            -  Habits of smoking, drugs and betel nut chewing&#xD;
  &#xD;
            -  Taking antibiotics and osteoporosis bisphosphonates and other drugs regularly&#xD;
  &#xD;
            -  People with cognitive function or physical and mental disabilities&#xD;
  &#xD;
            -  Severely impaired diseases (for example: cancer, renal function or liver failure,&#xD;
               etc.)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>WEI-FU HUANG, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chimei Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Chimei Medical Center</name>
        <address>
          <city>Tainan</city>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>CHIH-CHANG CHEN, Master</last_name>
        <phone>+886-7-3121101</phone>
        <phone_ext>2159</phone_ext>
        <email>R0990137@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Augmented Reality</keyword>
    <keyword>Periodontal Health</keyword>
    <keyword>Blood Sugar Control</keyword>
    <keyword>Type 2 Diabetes Mellitus</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontal Diseases</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05993741
  org study id: 11111-011
  nct id: NCT05993741
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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-AR), AR health consulting group (EG-ARHC) and control group
        (CG), respectively. The EG-AR and EG-ARHC 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 Chimei Hospital Yongkang and Liuying Campus.
  
        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-ups.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Gingival index (GI)
  time frame: 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:
  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
  measure: Gingival index (GI)
  time frame: 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:
  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
  measure: Gingival index (GI)
  time frame: 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:
  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
  measure: Gingival index (GI)
  time frame: 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:
  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
  measure: Plaque index (PI)
  time frame: Change from Baseline PI at 1-month after intervention
  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
  measure: Plaque index (PI)
  time frame: Change from Baseline PI at 3-month after intervention
  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
  measure: Plaque index (PI)
  time frame: Change from Baseline PI at 6-month after intervention
  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
  measure: Plaque index (PI)
  time frame: Change from Baseline PI at 1-year after intervention
  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
  measure: Probing Pocket Depth (PPD)
  time frame: 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.
  For each patient, PPD will measured each teeth.
  measure: Probing Pocket Depth (PPD)
  time frame: 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.
  For each patient, PPD will measured each teeth.
  measure: Probing Pocket Depth (PPD)
  time frame: 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.
  For each patient, PPD will measured each teeth.
  measure: Probing Pocket Depth (PPD)
  time frame: 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.
  For each patient, PPD will measured each teeth.
  measure: Clinical Attachment Loss(CAL)
  time frame: 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. For each patient, CAL will measured each teeth.
  measure: Clinical Attachment Loss(CAL)
  time frame: 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. For each patient, CAL will measured each teeth.
  measure: Clinical Attachment Loss(CAL)
  time frame: 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. For each patient, CAL will measured each teeth.
  measure: Clinical Attachment Loss(CAL)
  time frame: 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. For each patient, CAL will measured each teeth.
  measure: Plaque Control Record (PCR)
  time frame: 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).
  For each patient, PCR will measured each teeth.
  measure: Plaque Control Record (PCR)
  time frame: 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).
  For each patient, PCR will measured each teeth.
  measure: Plaque Control Record (PCR)
  time frame: 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).
  For each patient, PCR will measured each teeth.
  measure: Plaque Control Record (PCR)
  time frame: 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).
  For each patient, PCR will measured each teeth.
  measure: Oral health knowledge
  time frame: 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
  time frame: 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
  time frame: 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
  time frame: 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
  time frame: 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
  time frame: 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
  time frame: 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
  time frame: 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)
  time frame: 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)
  time frame: 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)
  time frame: 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)
  time frame: 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
  arm group label: AR group (EG-AR)
  arm group type: Experimental
  description: Behavioral: AR intervention For the EG-AR, 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 group label: AR-health consulting group (EG-ARHC)
  arm group type: Experimental
  description: AR intervention For the EG-B, the ARHC 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 group label: Control group (CG)
  arm group type: No Intervention
  description: the control group(CG) only have standard oral hygiene education
  intervention type: Device
  intervention name: AR Dental Care Training System
  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.
  arm group label: AR group (EG-AR)
  arm group label: AR-health consulting group (EG-ARHC)
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: WEI-FU HUANG, MD
  role: Principal Investigator
  affiliation: Chimei Medical Center
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Periodontal Diseases
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2