<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/NCT04473209</url>
  </required_header>
  <id_info>
    <org_study_id>version 1</org_study_id>
    <nct_id>NCT04473209</nct_id>
  </id_info>
  <brief_title>Serum Resistin Level Following Non-surgical Periodontal Therapy in Diabetic Patients With Chronic Periodontitis</brief_title>
  <official_title>The Effect of Non-surgical Periodontal Therapy on Serum Resistin Level in Chronic Periodontitis Patients With or Without Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      non-surgical periodontal debridement was performed for diabetic patients with chronic&#xD;
      periodontitis as well as for non-diabetic patients but also with chronic periodontitis. Serum&#xD;
      resistin level was assessed in the two groups before and after periodontal therapy and also&#xD;
      was compared to a healthy control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Resisitin is a recognized marker for chronic inflammatory conditions that could&#xD;
      be directly linked with type 2 diabetes mellitus. The aim of this study was to assess serum&#xD;
      resistin level in type 2 diabetic patients with chronic periodontitis.&#xD;
&#xD;
      Methods: Forty individuals were recruited in this study and were divided into three groups,&#xD;
      diabetic group consisted of 15 diabetic patients (type 2 diabetes mellitus) with moderate to&#xD;
      severe chronic periodontitis, non-diabetic group consisted of 15 non-diabetic patients with&#xD;
      moderate to severe chronic periodontitis and healthy group consisted of 10 non-diabetic&#xD;
      individuals with healthy periodontium. Non-surgical periodontal therapy with supra and&#xD;
      subgingival debridement was performed for the diabetic and non-diabetic groups. Pocket depth,&#xD;
      clinical attachment level, plaque index, gingival index, serum Resistin and high sensitivity&#xD;
      C-Reactive Protein assay were recorded for both groups before and after treatment, while&#xD;
      HbA1c was recorded for the diabetic group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>group1: diabetic patients with chronic periodontitis group2: non diabetic patients with chronic periodontitis</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>serum resistin</measure>
    <time_frame>3 months</time_frame>
    <description>ng/ml</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>3 months</time_frame>
    <description>μg/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>probing pocket depth</measure>
    <time_frame>3 months</time_frame>
    <description>mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical attachment loss</measure>
    <time_frame>3 months</time_frame>
    <description>mm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>diabetic group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>diabetic patients with chronic periodontitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-diabetic group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>non diabetic patients with chronic periodontitis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>non-surgical periodontal therapy</intervention_name>
    <description>supra and subgingival debridement</description>
    <arm_group_label>diabetic group</arm_group_label>
    <arm_group_label>non-diabetic group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed with moderate to severe chronic periodontitis.&#xD;
&#xD;
          -  Presence of a minimum of 15 natural teeth&#xD;
&#xD;
          -  Presence of at least four teeth with one or more sites with probing pocket depth (PPD)&#xD;
             ≥5mm and clinical attachment level (CAL) ≥4mm&#xD;
&#xD;
          -  agreement to participate in the study and sign a written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who received any periodontal treatment or professional scaling and root&#xD;
             planing of the teeth for at least 6 months prior to the study initiation&#xD;
&#xD;
          -  A history of antibiotics therapy and anti-inflammatory drugs within the previous 6&#xD;
             months&#xD;
&#xD;
          -  Pregnancy or use of contraceptives or any medication related to diabetes&#xD;
&#xD;
          -  former or current smokers ˂ 5 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>11865</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 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 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Weam Ahmed Elbattawy</investigator_full_name>
    <investigator_title>Dr. Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT04473209
org study id: version 1
nct id: NCT04473209
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
non-surgical periodontal debridement was performed for diabetic patients with chronic
      periodontitis as well as for non-diabetic patients but also with chronic periodontitis. Serum
      resistin level was assessed in the two groups before and after periodontal therapy and also
      was compared to a healthy control group.
Background: Resisitin is a recognized marker for chronic inflammatory conditions that could
      be directly linked with type 2 diabetes mellitus. The aim of this study was to assess serum
      resistin level in type 2 diabetic patients with chronic periodontitis.

      Methods: Forty individuals were recruited in this study and were divided into three groups,
      diabetic group consisted of 15 diabetic patients (type 2 diabetes mellitus) with moderate to
      severe chronic periodontitis, non-diabetic group consisted of 15 non-diabetic patients with
      moderate to severe chronic periodontitis and healthy group consisted of 10 non-diabetic
      individuals with healthy periodontium. Non-surgical periodontal therapy with supra and
      subgingival debridement was performed for the diabetic and non-diabetic groups. Pocket depth,
      clinical attachment level, plaque index, gingival index, serum Resistin and high sensitivity
      C-Reactive Protein assay were recorded for both groups before and after treatment, while
      HbA1c was recorded for the diabetic group.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: group1: diabetic patients with chronic periodontitis group2: non diabetic patients with chronic periodontitis
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: serum resistin
time frame: 3 months
description: ng/ml
measure: C-reactive protein
time frame: 3 months
description: μg/mL
measure: probing pocket depth
time frame: 3 months
description: mm
measure: clinical attachment loss
time frame: 3 months
description: mm
arm group label: diabetic group
arm group type: Active Comparator
description: diabetic patients with chronic periodontitis
arm group label: non-diabetic group
arm group type: Active Comparator
description: non diabetic patients with chronic periodontitis
intervention type: Procedure
intervention name: non-surgical periodontal therapy
description: supra and subgingival debridement
arm group label: diabetic group
arm group label: non-diabetic group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Weam Ahmed Elbattawy
investigator title: Dr. Principal Investigator
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Diabetes Mellitus, Type 2