<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/NCT04470635</url>
  </required_header>
  <id_info>
    <org_study_id>2020/114</org_study_id>
    <nct_id>NCT04470635</nct_id>
  </id_info>
  <brief_title>Thiol/Disulphide Homeostasis and Vascular Endothelial Growth Factor Levels in Diabetic Children</brief_title>
  <official_title>Thiol/Disulphide Homeostasis and Salivary Vascular Endothelial Growth Factor Levels in Type 1 Diabetic Patients With Gingivitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aydin Adnan Menderes University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aydin Adnan Menderes University</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 to evaluate the vascular endothelial growth factor level and&#xD;
      thiol/disulphide homeostasis in saliva of diabetic children with gingivitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eighty children (44 with type 1 diabetes mellitus and 44 systemically healthy) will be&#xD;
      recruited for the study. The children will be divided into four subgroups based on their&#xD;
      periodontal and systemic condition: 1) systemically and periodontally healthy children, 2)&#xD;
      systemically healthy children with gingivitis, 3) periodontally healthy children with T1DM,&#xD;
      and 4) children with T1DM and gingivitis. The plaque index, gingival index, probing pocket&#xD;
      depth, will recorded. The vascular endothelial growth factor level determined by ELISA.&#xD;
      Native thiol, total thiol and disulphide levels will be measured in saliva.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 25, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Vascular endothelial growth factor level</measure>
    <time_frame>Baseline</time_frame>
    <description>Vascular endothelial growth factor level in saliva</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Thiol/disulphide measurement</measure>
    <time_frame>Baseline</time_frame>
    <description>Total thiol, native thiol and disulphite level in saliva</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>Type 1 diabetes with gingivitis</arm_group_label>
    <description>Children with type 1 diabetes mellitus and gingivitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 1 diabetes with healthy gingiva</arm_group_label>
    <description>Children with type 1 diabetes mellitus and healthy gingiva</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy children with gingivitis</arm_group_label>
    <description>Systemically healthy children with gingivitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy children and healthy gingiva</arm_group_label>
    <description>Systemically healthy children with healthy gingiva</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ELISA</intervention_name>
    <description>Saliva sample collection</description>
    <arm_group_label>Healthy children and healthy gingiva</arm_group_label>
    <arm_group_label>Healthy children with gingivitis</arm_group_label>
    <arm_group_label>Type 1 diabetes with gingivitis</arm_group_label>
    <arm_group_label>Type 1 diabetes with healthy gingiva</arm_group_label>
    <other_name>Thiol/disulphide measurement</other_name>
    <other_name>Total thiol, native thiol and disulphide level</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Eigthy children will be recuited for the study . The children will be classified into four&#xD;
        subgroups based on their periodontal status;&#xD;
&#xD;
        1) systemically and periodontally healthy children, 2) systemically healthy children with&#xD;
        gingivitis (G), 3) periodontally healthy children with T1DM, and 4) children with T1DM and&#xD;
        gingivitis . The plaque index, gingival index and probing pocket depth will be recorded.&#xD;
        The vascular endothelial growth factor in saliva will be determined by ELISA. Additionally&#xD;
        total and native thiao and disulphide levels in saliva will be determined.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children diagnosed as type 1 diabetes mellitus&#xD;
&#xD;
          -  Age between 7-14 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having another systemic problem except type 1 diabetes mellitus&#xD;
&#xD;
          -  Children carrying orthodontic appliances&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Sultan KELES, Assoc.Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aydin Adnan Menderes University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sultan KELES, Assoc.Prof.</last_name>
    <phone>05318438557</phone>
    <email>dtsultank@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ozge CEVIK, Assoc.Prof.</last_name>
    <phone>05365573259</phone>
    <email>ozge.cevik@adu.edu.tr</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aydin Adnan Menderes University</investigator_affiliation>
    <investigator_full_name>Sultan KELES</investigator_full_name>
    <investigator_title>Assoc.Prof.Dr</investigator_title>
  </responsible_party>
  <keyword>type 1 diabetes mellitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04470635
org study id: 2020/114
nct id: NCT04470635
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study to evaluate the vascular endothelial growth factor level and
      thiol/disulphide homeostasis in saliva of diabetic children with gingivitis.
Eighty children (44 with type 1 diabetes mellitus and 44 systemically healthy) will be
      recruited for the study. The children will be divided into four subgroups based on their
      periodontal and systemic condition: 1) systemically and periodontally healthy children, 2)
      systemically healthy children with gingivitis, 3) periodontally healthy children with T1DM,
      and 4) children with T1DM and gingivitis. The plaque index, gingival index, probing pocket
      depth, will recorded. The vascular endothelial growth factor level determined by ELISA.
      Native thiol, total thiol and disulphide levels will be measured in saliva.
observational model: Case-Control
time perspective: Prospective
measure: Vascular endothelial growth factor level
time frame: Baseline
description: Vascular endothelial growth factor level in saliva
measure: Thiol/disulphide measurement
time frame: Baseline
description: Total thiol, native thiol and disulphite level in saliva
arm group label: Type 1 diabetes with gingivitis
description: Children with type 1 diabetes mellitus and gingivitis
arm group label: Type 1 diabetes with healthy gingiva
description: Children with type 1 diabetes mellitus and healthy gingiva
arm group label: Healthy children with gingivitis
description: Systemically healthy children with gingivitis
arm group label: Healthy children and healthy gingiva
description: Systemically healthy children with healthy gingiva
intervention type: Diagnostic Test
intervention name: ELISA
description: Saliva sample collection
arm group label: Healthy children and healthy gingiva
arm group label: Healthy children with gingivitis
arm group label: Type 1 diabetes with gingivitis
arm group label: Type 1 diabetes with healthy gingiva
other name: Thiol/disulphide measurement
other name: Total thiol, native thiol and disulphide level
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 14 Years
last name: Sultan KELES, Assoc.Prof.
role: Principal Investigator
affiliation: Aydin Adnan Menderes University
last name: Sultan KELES, Assoc.Prof.
phone: 05318438557
email: dtsultank@gmail.com
last name: Ozge CEVIK, Assoc.Prof.
phone: 05365573259
email: ozge.cevik@adu.edu.tr
responsible party type: Principal Investigator
investigator affiliation: Aydin Adnan Menderes University
investigator full name: Sultan KELES
investigator title: Assoc.Prof.Dr
mesh term: Periodontal Diseases
sharing ipd: No