<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/NCT03269799</url>
  </required_header>
  <id_info>
    <org_study_id>2016/DT068</org_study_id>
    <nct_id>NCT03269799</nct_id>
  </id_info>
  <brief_title>Vitamin C as an Adjunct in Periodontal Treatment in Type 2 Diabetes Mellitus Patients</brief_title>
  <official_title>The Effect of Vitamin C as an Adjunct in Periodontal Treatment in Uncontrolled Type 2 Diabetes Mellitus Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Periodontitis patients with uncontrolled type 2 diabetes mellitus will receive non-surgical&#xD;
      periodontal treatment and then be supplemented with daily 500 mg vitamin C (test group) or&#xD;
      placebo (control group) for 2 months. Clinical parameters will be retrieved at baseline, at&#xD;
      the end of week 4 and at the end of week 8.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 30, 2017</start_date>
  <completion_date type="Anticipated">August 19, 2018</completion_date>
  <primary_completion_date type="Anticipated">February 19, 2018</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sulcus bleeding index</measure>
    <time_frame>baseline, change from baseline sulcus bleeding index at 4 weeks, change from baseline sulcus bleeding index at 8 weeks</time_frame>
    <description>bleeding upon probing of gingival sulcus from the most severe periodontitis tooth</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Diabetes Mellitus Type 2 With Hyperglycemia</condition>
  <condition>Periodontitis</condition>
  <arm_group>
    <arm_group_label>test group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>vitamin C 500 mg oral capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin C 500 MG Oral Capsule</intervention_name>
    <description>non surgical periodontal treatment+vitamin C 500 mg/day for 2 months</description>
    <arm_group_label>test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>non surgical periodontal treatment+placebo for 2 months</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  uncontrolled type 2 diabetes mellitus&#xD;
&#xD;
          -  periodontitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  complications from diabetes mellitus, e.g., renal insufficiency&#xD;
&#xD;
          -  receive insulin&#xD;
&#xD;
          -  diseases that interfere with wound healing, e.g., HIV&#xD;
&#xD;
          -  receive one of the followings: tetracycline, acetaminophen, NSAID, warfarin,&#xD;
             aluminum-containing antacids, barbiturates, phenobarbital, pentobarbital,&#xD;
             secobarbital, hormone replacement therapy, chemotherapeutic drug, protease inhibitor&#xD;
&#xD;
          -  receive other vitamins or antibiotics within 6 months&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nis Okuma, DDS, MD, M.Sc (Oral Medicine)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Dentistry, Mahidol University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Piyapat Kunsongkeit, DDS</last_name>
    <phone>+66870491014</phone>
    <email>pkunsongkeit@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Supanee Rassameemasmaung, DDS, M.Sc (Periodontics), Ph.D</last_name>
    <phone>+66867766255</phone>
    <email>supanee.ras@mahidol.ac.th</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Burapha University Hospital</name>
      <address>
        <city>Chon Buri</city>
        <zip>20130</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Piyapat Kunsongkeit, DDS</last_name>
      <phone>+66870491014</phone>
      <email>pkunsongkeit@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Pechngam Chaivanit, MD</last_name>
      <phone>+6638386554</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Supanee Rassameemasmaung</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>uncontrolled type 2 diabetes mellitus</keyword>
  <keyword>periodontitis</keyword>
  <keyword>non surgical periodontal treatment</keyword>
  <keyword>vitamin C</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03269799
org study id: 2016/DT068
nct id: NCT03269799
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Periodontitis patients with uncontrolled type 2 diabetes mellitus will receive non-surgical
      periodontal treatment and then be supplemented with daily 500 mg vitamin C (test group) or
      placebo (control group) for 2 months. Clinical parameters will be retrieved at baseline, at
      the end of week 4 and at the end of week 8.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: sulcus bleeding index
time frame: baseline, change from baseline sulcus bleeding index at 4 weeks, change from baseline sulcus bleeding index at 8 weeks
description: bleeding upon probing of gingival sulcus from the most severe periodontitis tooth
arm group label: test group
arm group type: Active Comparator
description: vitamin C 500 mg oral capsule
arm group label: control group
arm group type: Placebo Comparator
description: placebo
intervention type: Drug
intervention name: Vitamin C 500 MG Oral Capsule
description: non surgical periodontal treatment+vitamin C 500 mg/day for 2 months
arm group label: test group
intervention type: Other
intervention name: placebo
description: non surgical periodontal treatment+placebo for 2 months
arm group label: control group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Nis Okuma, DDS, MD, M.Sc (Oral Medicine)
role: Principal Investigator
affiliation: Faculty of Dentistry, Mahidol University
last name: Piyapat Kunsongkeit, DDS
phone: +66870491014
email: pkunsongkeit@gmail.com
last name: Supanee Rassameemasmaung, DDS, M.Sc (Periodontics), Ph.D
phone: +66867766255
email: supanee.ras@mahidol.ac.th
facility: 
status: Recruiting
contact: 
contact backup: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Supanee Rassameemasmaung
investigator title: Associate Professor
mesh term: Periodontitis
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Hyperglycemia
sharing ipd: Undecided