<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/NCT03009097</url>
  </required_header>
  <id_info>
    <org_study_id>kamineni perio</org_study_id>
    <nct_id>NCT03009097</nct_id>
  </id_info>
  <brief_title>Atorvastatin as an Adjunct to DFDBA in Intrabony Defects</brief_title>
  <official_title>&quot;Comparative Evaluation Of The Efficacy Of Atorvastatin Gel As An Adjunct To Allografts In The Treatment Of Intrabony Defects&quot; - A Clinico Radiological Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kamineni Institute of Dental Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kamineni Institute of Dental Sciences</source>
  <brief_summary>
    <textblock>
      Periodontitis is a major oral health problem which leads to the progressive destruction of&#xD;
      periodontal ligament and alveolar bone with pocket formation, recession or both. The ultimate&#xD;
      goal of periodontal therapy is to regenerate the lost periodontal tissue. The most common&#xD;
      form of regenerative periodontal therapy is the use of bone grafts which stimulate bone&#xD;
      formation by the processes of osteoinduction and osteoconduction.&#xD;
&#xD;
      Statins are a group of lipid lowering drugs which inhibit bone resorption by inhibition of&#xD;
      the enzyme HMG-CoA reductase. They also stimulate new bone formation by local stimulation of&#xD;
      BMP-2, a major bone growth regulatory factor. They also have anti-inflammatory and anti&#xD;
      oxidant properties.&#xD;
&#xD;
      Very few studies exist evaluating the beneficiary effects of grafts if combined with the&#xD;
      statins which might enhance the regeneration by bone grafts.&#xD;
&#xD;
      Hence, the present study was carried out in an attempt to comparatively evaluate clinically&#xD;
      and radiologically, the efficacy of atorvastatin gel as an adjunct to allograft in the&#xD;
      treatment of intrabony defects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 26 intrabony defects in patients with chronic periodontitis as diagnosed by&#xD;
      radiographs, were selected for the study after taking an informed consent. The selected sites&#xD;
      were randomized in 2 treatment groups.&#xD;
&#xD;
      Group I - sites were treated with allograft (DFDBA) Group II - sites were treated with&#xD;
      allograft (DFDBA) in combination with Atorvastatin gel.&#xD;
&#xD;
      Clinical parameters like probing depth and clinical attachment level and radiological&#xD;
      assessment of intrabony defect fill were done at baseline and 3 and 6 months postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>bone fill in mm was measured by taking radiographs</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Chronic Periaortitis</condition>
  <condition>Intrabony Periodontal Defect</condition>
  <arm_group>
    <arm_group_label>DFDBA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>13 intrabony defects in chronic periodontitis patients were treated with DFDBA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DFDBA with Atorvastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>13 intrabony defects in chronic periodontitis patients were treated with DFDBA in combination with Atorvastatin gel.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DFDBA</intervention_name>
    <description>13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA)</description>
    <arm_group_label>DFDBA</arm_group_label>
    <other_name>Allograft</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DFDBA with atorvastatin</intervention_name>
    <description>13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA) in combination with atorvastatin gel</description>
    <arm_group_label>DFDBA with Atorvastatin</arm_group_label>
    <other_name>atorvastatin gel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Systemically healthy individual based on personal and medical history.&#xD;
&#xD;
          2. Presentation of untreated Chronic Periodontitis with intrabony defect having probing&#xD;
             pocket depth (PPD) ≥5mm or clinical attachment loss of ≥ 3mm and radiographic signs of&#xD;
             angular bone loss.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients diagnosed and treated for systemic disease&#xD;
&#xD;
          2. Pregnant and Lactating women&#xD;
&#xD;
          3. Smokers&#xD;
&#xD;
          4. History of allergy to statin group or patients on systemic statin therapy.&#xD;
&#xD;
          5. History of antibiotic or periodontal therapy for the past 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Etika Rathi, MDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kamineni Institute of Dental Sciences</affiliation>
  </overall_official>
  <reference>
    <citation>Pradeep AR, Kumari M, Rao NS, Martande SS, Naik SB. Clinical efficacy of subgingivally delivered 1.2% atorvastatin in chronic periodontitis: a randomized controlled clinical trial. J Periodontol. 2013 Jul;84(7):871-9. doi: 10.1902/jop.2012.120393. Epub 2012 Oct 2.</citation>
    <PMID>23030241</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kamineni Institute of Dental Sciences</investigator_affiliation>
    <investigator_full_name>ETIKA RATHI</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Chronic periodontitis</keyword>
  <keyword>atorvastatin</keyword>
  <keyword>intrabony defect</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retroperitoneal Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</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/NCT03009097
org study id: kamineni perio
nct id: NCT03009097
lead sponsor: 
Periodontitis is a major oral health problem which leads to the progressive destruction of
      periodontal ligament and alveolar bone with pocket formation, recession or both. The ultimate
      goal of periodontal therapy is to regenerate the lost periodontal tissue. The most common
      form of regenerative periodontal therapy is the use of bone grafts which stimulate bone
      formation by the processes of osteoinduction and osteoconduction.

      Statins are a group of lipid lowering drugs which inhibit bone resorption by inhibition of
      the enzyme HMG-CoA reductase. They also stimulate new bone formation by local stimulation of
      BMP-2, a major bone growth regulatory factor. They also have anti-inflammatory and anti
      oxidant properties.

      Very few studies exist evaluating the beneficiary effects of grafts if combined with the
      statins which might enhance the regeneration by bone grafts.

      Hence, the present study was carried out in an attempt to comparatively evaluate clinically
      and radiologically, the efficacy of atorvastatin gel as an adjunct to allograft in the
      treatment of intrabony defects.
A total of 26 intrabony defects in patients with chronic periodontitis as diagnosed by
      radiographs, were selected for the study after taking an informed consent. The selected sites
      were randomized in 2 treatment groups.

      Group I - sites were treated with allograft (DFDBA) Group II - sites were treated with
      allograft (DFDBA) in combination with Atorvastatin gel.

      Clinical parameters like probing depth and clinical attachment level and radiological
      assessment of intrabony defect fill were done at baseline and 3 and 6 months postoperatively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: bone fill in mm was measured by taking radiographs
time frame: 6 months
arm group label: DFDBA
arm group type: Active Comparator
description: 13 intrabony defects in chronic periodontitis patients were treated with DFDBA
arm group label: DFDBA with Atorvastatin
arm group type: Active Comparator
description: 13 intrabony defects in chronic periodontitis patients were treated with DFDBA in combination with Atorvastatin gel.
intervention type: Biological
intervention name: DFDBA
description: 13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA)
arm group label: DFDBA
other name: Allograft
intervention type: Drug
intervention name: DFDBA with atorvastatin
description: 13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA) in combination with atorvastatin gel
arm group label: DFDBA with Atorvastatin
other name: atorvastatin gel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Etika Rathi, MDS
role: Principal Investigator
affiliation: Kamineni Institute of Dental Sciences
citation: Pradeep AR, Kumari M, Rao NS, Martande SS, Naik SB. Clinical efficacy of subgingivally delivered 1.2% atorvastatin in chronic periodontitis: a randomized controlled clinical trial. J Periodontol. 2013 Jul;84(7):871-9. doi: 10.1902/jop.2012.120393. Epub 2012 Oct 2.
PMID: 23030241
responsible party type: Principal Investigator
investigator affiliation: Kamineni Institute of Dental Sciences
investigator full name: ETIKA RATHI
investigator title: Principal investigator
mesh term: Retroperitoneal Fibrosis
mesh term: Atorvastatin