<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/NCT03043196</url>
  </required_header>
  <id_info>
    <org_study_id>GDCRI/ACM/PG/PhD/2/2014-2015HB</org_study_id>
    <nct_id>NCT03043196</nct_id>
  </id_info>
  <brief_title>1.2% Rosuvastatin Gel As A Local Agent In Smokers With Chronic Periodontitis</brief_title>
  <official_title>1.2% Rosuvastatin Gel As A Local Drug Delivery Agent In Smokers With Chronic Periodontitis- A Randomized 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>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the present study was to evaluate the effects of subgingival delivery of&#xD;
      Rosuvastatin gel as an adjunct to scaling and root planing in Smokers With Chronic&#xD;
      Periodontitis (CP) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Periodontal diseases are multi-factorial in etiology, and bacteria are one among&#xD;
      these etiologic agents. However, mechanical therapy itself may not always reduce or eliminate&#xD;
      the anaerobic infection at the base of the pocket, within the gingival tissues. To overcome&#xD;
      this, various systemic and local drug delivered antimicrobials have been used as an adjunct&#xD;
      to scaling and root planing (SRP).The present study aims to explore the efficacy of 1.2%&#xD;
      rosuvastatin (RSV) gel local drug delivery as an adjunct to SRP in smokers with chronic&#xD;
      periodontitis (CP).&#xD;
&#xD;
      Methods: Sixty subjects were randomly allocated into two treatment groups: SRP with placebo&#xD;
      gel (group 1), SRP with 1.2% RSV gel (group 2). Clinical parameters were recorded at&#xD;
      baseline, 6 and 9 months. Radiographic assessment was done using computer aided software at&#xD;
      baseline, 6 and 9 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 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">60</enrollment>
  <condition>Chronic Periodontitis</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 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;
          -  Systemically healthy CP subjects aged between 30-50 years who are current smokers with&#xD;
             no history of periodontal therapy or use of antibiotics in past 6 months, having sites&#xD;
             with intrabony defect depth (IBD) ≥ 3mm (distance between alveolar crest and base of&#xD;
             the defect on intraoral periapical radiograph) along with PPD ≥5 mm or CAL ≥3 mm in an&#xD;
             asymptomatic tooth were included in the study.&#xD;
&#xD;
        A subject was considered as a current smoker if he regularly smoked more than 10&#xD;
        cigarettes/day for a minimum of 5 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Former smokers, i.e. subjects who had previously been smokers but stopped their habit,&#xD;
             and non-smokers were excluded. Subjects allergic to statins, on systemic statin&#xD;
             therapy, with any known systemic disease or any other systemic inflammation/ infection&#xD;
             which could alter the course of periodontal disease and users of tobacco in any other&#xD;
             form than cigarettes were excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 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>February 2017</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</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 HOD, 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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rosuvastatin Calcium</mesh_term>
  </intervention_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/NCT03043196
org study id: GDCRI/ACM/PG/PhD/2/2014-2015HB
nct id: NCT03043196
lead sponsor: 
has dmc: No
The purpose of the present study was to evaluate the effects of subgingival delivery of
      Rosuvastatin gel as an adjunct to scaling and root planing in Smokers With Chronic
      Periodontitis (CP) patients.
Background: Periodontal diseases are multi-factorial in etiology, and bacteria are one among
      these etiologic agents. However, mechanical therapy itself may not always reduce or eliminate
      the anaerobic infection at the base of the pocket, within the gingival tissues. To overcome
      this, various systemic and local drug delivered antimicrobials have been used as an adjunct
      to scaling and root planing (SRP).The present study aims to explore the efficacy of 1.2%
      rosuvastatin (RSV) gel local drug delivery as an adjunct to SRP in smokers with chronic
      periodontitis (CP).

      Methods: Sixty subjects were randomly allocated into two treatment groups: SRP with placebo
      gel (group 1), SRP with 1.2% RSV gel (group 2). Clinical parameters were recorded at
      baseline, 6 and 9 months. Radiographic assessment was done using computer aided software at
      baseline, 6 and 9 months.
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 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: 50 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 HOD, Dept of Periodontology
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Rosuvastatin Calcium
sharing ipd: Undecided