<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/NCT03807596</url>
  </required_header>
  <id_info>
    <org_study_id>15062011</org_study_id>
    <nct_id>NCT03807596</nct_id>
  </id_info>
  <brief_title>Hyaluronic Acid With Scaling &amp; Root Planing In Chronic Periodontitis Patients With Diabetes Mellitus Type 2</brief_title>
  <official_title>Adjunctive Use Of Hyaluronic Acid With Scaling &amp; Root Planing In Treatment of Chronic Periodontitis Patients With Diabetes Mellitus Type 2: A Randomized Controlled Trial</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>
      The present study aimed to assess the adjunctive use of Hyaluronic acid with scaling &amp; root&#xD;
      planing (SRP) in patients with chronic periodontitis &amp; diabetes mellitus type 2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty subjects with chronic periodontitis &amp; diabetes mellitus type 2 were included in this&#xD;
      randomized clinical trial. These subjects were randomly allocated into test &amp; control equal&#xD;
      groups. The test group comprised fifteen patients who received SRP with subgingival&#xD;
      application of Hyaluronic acid as an adjunct. The control group included fifteen patients who&#xD;
      received SRP alone. Plaque index (PI), gingival index (GI), probing depth (PD) &amp; clinical&#xD;
      attachment level (CAL) were measured &amp; documented at baseline, 6 weeks &amp; 12 weeks intervals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 16, 2017</start_date>
  <completion_date type="Actual">June 29, 2017</completion_date>
  <primary_completion_date type="Actual">June 29, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gain in clinical attachment level</measure>
    <time_frame>12 weeks</time_frame>
    <description>Gain in clinical attachment level will be measured in millimeter by William's graduated periodontal probe</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>SRP group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chronic periodontitis patients with type 2 diabetes mellitus recieved Periodontal treatment in the form of scaling &amp; root planing (SRP) alone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyaluronic acid &amp; SRP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chronic periodontitis &amp; type 2 diabetes mellitus patients received Periodontal treatment in the form of scaling &amp; root planing (SRP) with the adjunctive use of hyaluronic acid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Periodontal treatment with Hyaluronic acid associated with SRP</intervention_name>
    <description>In addition to SRP, patients in the test group received adjunct subgingival application of hyaluronic acid in all selected periodontal pockets.</description>
    <arm_group_label>Hyaluronic acid &amp; SRP group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Scaling &amp; root planning alone</intervention_name>
    <description>Patients received full-mouth supra- &amp; sub-gingival SRP with the use of ultrasonic device &amp; periodontal universal &amp; Gracey curettes under local anesthesia.</description>
    <arm_group_label>SRP group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic periodontitis and type 2 diabetes mellitus&#xD;
&#xD;
          -  Minimum of 20 teeth&#xD;
&#xD;
          -  Clinical attachment level (CAL) ≥ 3 mm&#xD;
&#xD;
          -  Probing depth (PD) ≥ 4 mm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Smokers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>38 Months</minimum_age>
    <maximum_age>56 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gihane G Madkour, Ass Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Dentistry, Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>12411</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Gihane Gharib Madkour</investigator_full_name>
    <investigator_title>Associate Professor</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</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_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/NCT03807596
org study id: 15062011
nct id: NCT03807596
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study aimed to assess the adjunctive use of Hyaluronic acid with scaling & root
      planing (SRP) in patients with chronic periodontitis & diabetes mellitus type 2.
Thirty subjects with chronic periodontitis & diabetes mellitus type 2 were included in this
      randomized clinical trial. These subjects were randomly allocated into test & control equal
      groups. The test group comprised fifteen patients who received SRP with subgingival
      application of Hyaluronic acid as an adjunct. The control group included fifteen patients who
      received SRP alone. Plaque index (PI), gingival index (GI), probing depth (PD) & clinical
      attachment level (CAL) were measured & documented at baseline, 6 weeks & 12 weeks intervals.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Gain in clinical attachment level
time frame: 12 weeks
description: Gain in clinical attachment level will be measured in millimeter by William's graduated periodontal probe
arm group label: SRP group
arm group type: Active Comparator
description: Chronic periodontitis patients with type 2 diabetes mellitus recieved Periodontal treatment in the form of scaling & root planing (SRP) alone.
arm group label: Hyaluronic acid & SRP group
arm group type: Experimental
description: Chronic periodontitis & type 2 diabetes mellitus patients received Periodontal treatment in the form of scaling & root planing (SRP) with the adjunctive use of hyaluronic acid.
intervention type: Procedure
intervention name: Periodontal treatment with Hyaluronic acid associated with SRP
description: In addition to SRP, patients in the test group received adjunct subgingival application of hyaluronic acid in all selected periodontal pockets.
arm group label: Hyaluronic acid & SRP group
intervention type: Procedure
intervention name: Scaling & root planning alone
description: Patients received full-mouth supra- & sub-gingival SRP with the use of ultrasonic device & periodontal universal & Gracey curettes under local anesthesia.
arm group label: SRP group
criteria: 
gender: All
minimum age: 38 Months
maximum age: 56 Months
healthy volunteers: No
last name: Gihane G Madkour, Ass Prof
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Gihane Gharib Madkour
investigator title: Associate Professor
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Hyaluronic Acid
sharing ipd: No