<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/NCT02985099</url>
  </required_header>
  <id_info>
    <org_study_id>GDCRI/ACM/PG/PhD/2/2013-2014DK</org_study_id>
    <nct_id>NCT02985099</nct_id>
  </id_info>
  <brief_title>1.2% Rosuvastatin Subgingivally Delivered In Chronic Periodontitis With Type 2 Diabetes Mellitus</brief_title>
  <official_title>1.2% Rosuvastatin Subgingivally Delivered In Treatment Of Chronic Periodontitis With Type 2 Diabetes Mellitus: A Placebo Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Government Dental College and Research Institute, Bangalore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Government Dental College and Research Institute, Bangalore</source>
  <brief_summary>
    <textblock>
      The purpose of the present study was to evaluate the effects of subgingival delivery of 1.2%&#xD;
      Rosuvastatin (RSV) gel as an adjunct to scaling and root planing in chronic periodontitis&#xD;
      (CP) with Type 2 diabetes mellitus patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The purpose of this double-masked, randomized, controlled clinical trial was to&#xD;
      evaluate the effects of subgingival delivery of 1.2% Rosuvastatin gel as an adjunct to&#xD;
      scaling and root planing (SRP) on clinical and radiographic parameters and compare this&#xD;
      method with SRP plus placebo gel alone in chronic periodontitis (CP) with type 2 DM patients.&#xD;
&#xD;
      Methods: Eighty CP patients with type 2 DM are included in this study. They were divided into&#xD;
      two groups: 1) SRP + 1.2% Rosuvastatin gel (RSV group); 2) SRP + Placebo gel (Placebo group).&#xD;
      At baseline, 3, 6 and 9 months after treatment, clinical measurements, including plaque index&#xD;
      (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level&#xD;
      (CAL) and radiographic parameters intrabony defect depth (IBD), percentage change in&#xD;
      radiographic defect depth reduction (DDR%) were assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Defect depth reduction (%)</measure>
    <time_frame>Change from baseline to 9 months</time_frame>
    <description>Assessed in percentage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>probing depth (mm)</measure>
    <time_frame>Change from baseline to 9 months</time_frame>
    <description>measured in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical attachment level (mm)</measure>
    <time_frame>Change from baseline to 9 months</time_frame>
    <description>measured in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified sulcus bleeding index</measure>
    <time_frame>Change from baseline to 9 months</time_frame>
    <description>scale from 0-3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plaque index</measure>
    <time_frame>Change from baseline to 9 months</time_frame>
    <description>scale from 0-3</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Chronic Periodontitis</condition>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Rosuvastatin group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral prophylaxis followed by placebo gel placement in intrabony defects</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SRP plus Rosuvastatin gel</intervention_name>
    <description>SRP followed by 1.2% Rosuvastatin placement into intrabony defect</description>
    <arm_group_label>Rosuvastatin group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SRP plus placebo gel</intervention_name>
    <description>SRP followed by placebo gel placement into intrabony defect</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetic patients with deep pockets (PD of ≥5mm or CAL ≥4mm) and vertical bone&#xD;
             loss ≥3 mm on intraoral periapical radiographs&#xD;
&#xD;
          -  Patients with ≥20 teeth with no history of periodontal therapy in the preceding 6&#xD;
             months nor under any antibiotic therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any other known systemic disease&#xD;
&#xD;
          -  Patients on systemic statin therapy&#xD;
&#xD;
          -  Known or suspected allergy to statin supplementation&#xD;
&#xD;
          -  Patients with aggressive periodontitis&#xD;
&#xD;
          -  Tobacco use in any form, smokers, alcoholics&#xD;
&#xD;
          -  Immunocompromised patients&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Government Dental College and Research Institute</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 4, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 4, 2016</last_update_submitted>
  <last_update_submitted_qc>December 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Government Dental College and Research Institute, Bangalore</investigator_affiliation>
    <investigator_full_name>Dr. A R Pradeep</investigator_full_name>
    <investigator_title>Professor and Head, Dept of Periodontology</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>Rosuvastatin Calcium</mesh_term>
  </intervention_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/NCT02985099
org study id: GDCRI/ACM/PG/PhD/2/2013-2014DK
nct id: NCT02985099
lead sponsor: 
The purpose of the present study was to evaluate the effects of subgingival delivery of 1.2%
      Rosuvastatin (RSV) gel as an adjunct to scaling and root planing in chronic periodontitis
      (CP) with Type 2 diabetes mellitus patients.
Background: The purpose of this double-masked, randomized, controlled clinical trial was to
      evaluate the effects of subgingival delivery of 1.2% Rosuvastatin gel as an adjunct to
      scaling and root planing (SRP) on clinical and radiographic parameters and compare this
      method with SRP plus placebo gel alone in chronic periodontitis (CP) with type 2 DM patients.

      Methods: Eighty CP patients with type 2 DM are included in this study. They were divided into
      two groups: 1) SRP + 1.2% Rosuvastatin gel (RSV group); 2) SRP + Placebo gel (Placebo group).
      At baseline, 3, 6 and 9 months after treatment, clinical measurements, including plaque index
      (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level
      (CAL) and radiographic parameters intrabony defect depth (IBD), percentage change in
      radiographic defect depth reduction (DDR%) were assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Defect depth reduction (%)
time frame: Change from baseline to 9 months
description: Assessed in percentage
measure: probing depth (mm)
time frame: Change from baseline to 9 months
description: measured in mm
measure: clinical attachment level (mm)
time frame: Change from baseline to 9 months
description: measured in mm
measure: modified sulcus bleeding index
time frame: Change from baseline to 9 months
description: scale from 0-3
measure: plaque index
time frame: Change from baseline to 9 months
description: scale from 0-3
arm group label: Rosuvastatin group
arm group type: Active Comparator
description: Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects
arm group label: Placebo group
arm group type: Placebo Comparator
description: Oral prophylaxis followed by placebo gel placement in intrabony defects
intervention type: Drug
intervention name: SRP plus Rosuvastatin gel
description: SRP followed by 1.2% Rosuvastatin placement into intrabony defect
arm group label: Rosuvastatin group
intervention type: Drug
intervention name: SRP plus placebo gel
description: SRP followed by placebo gel placement into intrabony defect
arm group label: Placebo group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Government Dental College and Research Institute, Bangalore
investigator full name: Dr. A R Pradeep
investigator title: Professor and Head, Dept of Periodontology
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Rosuvastatin Calcium