<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/NCT03041480</url>
  </required_header>
  <id_info>
    <org_study_id>MADC/IRB/2015/91</org_study_id>
    <nct_id>NCT03041480</nct_id>
  </id_info>
  <brief_title>Serum Lipid Levels and Lp-PLA2 in Chronic Periodontitis</brief_title>
  <official_title>The Association Between Periodontal Status, Serum Lipid Levels and Lipoprotein Associated Lipophosphase A2(Lp-PLA2) in Chronic Periodontitis Subjects and Healthy Controls: A Case Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meenakshi Ammal Dental College and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meenakshi Ammal Dental College and Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To assess the association between periodontal parameters, serum lipid profile and Lp-PLA2&#xD;
      level in systemically healthy Chronic Periodontitis subjects and healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Seventy five participants were divided into 3 groups. The groups consisted of GROUP I-&#xD;
      generalized severe chronic periodontitis, GROUP II- generalized moderate chronic&#xD;
      periodontitis and GROUP III- systemically and periodontally healthy volunteers who served as&#xD;
      control. The selected patients were then evaluated for periodontal parameters, lipid profile&#xD;
      and Lp-PLA2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2015</start_date>
  <completion_date type="Actual">November 26, 2015</completion_date>
  <primary_completion_date type="Actual">August 23, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Estimation of serum Lp-PLA2</measure>
    <time_frame>9 months</time_frame>
    <description>Serum Lp-PLA2 was estimated in all the groups using ELISA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimation of serum lipid profile</measure>
    <time_frame>9 months</time_frame>
    <description>Serum Total cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein and very low density lipoprotein</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">75</enrollment>
  <condition>Chronic Periodontitis (Disorder)</condition>
  <arm_group>
    <arm_group_label>GROUP I</arm_group_label>
    <description>Estimation of serum lipid levels and Lp-PLA2 in generalized severe chronic periodontitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GROUP II</arm_group_label>
    <description>Estimation of serum lipid levels and Lp-PLA2 in generalized moderate chronic periodontitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GROUP III</arm_group_label>
    <description>Estimation of serum lipid levels and Lp-PLA2 in systemically and periodontally healthy controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>serum lipid levels and Lp-PLA2</intervention_name>
    <description>Estimation of Total Cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein, very low density lipoprotein and Lipoprotein associated lipophosphase A2 in chronic periodontitis</description>
    <arm_group_label>GROUP I</arm_group_label>
    <arm_group_label>GROUP II</arm_group_label>
    <arm_group_label>GROUP III</arm_group_label>
    <other_name>Biological marker</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population was selected from the Department of Periodontology, Meenakshi Ammal&#xD;
        Dental College&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Group I:&#xD;
&#xD;
          1. Subjects with age ≥ 35 years.&#xD;
&#xD;
          2. Presence of at least 24 teeth, with Clinical attachment loss (CAL) ≥ 5mm in more than&#xD;
             30% of sites.&#xD;
&#xD;
        Group II:&#xD;
&#xD;
          1. Subjects with age ≥ 35 years.&#xD;
&#xD;
          2. Presence of at least 24 teeth, with Clinical attachment loss (CAL) between 3-4 mm in&#xD;
             more than 30% of sites.&#xD;
&#xD;
        Group III:&#xD;
&#xD;
          1. Subjects with age ≥ 35 years.&#xD;
&#xD;
          2. Healthy and intact periodontium&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of any systemic disease or conditions that could affect periodontal tissues.&#xD;
&#xD;
          2. History of periodontal treatment in past 6 months.&#xD;
&#xD;
          3. Smoking and alcoholism&#xD;
&#xD;
          4. Anomalies of blood and immune system&#xD;
&#xD;
          5. Systemic medication or antibiotic treatment for the previous 6 months.&#xD;
&#xD;
          6. Pregnant females.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bittu Koshy, BDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meenakshi Ammal Dental College</affiliation>
  </overall_official>
  <reference>
    <citation>Zhou SY, Xiao WM, Ouyang XY. Lipoprotein-associated phospholipase A2 and serum lipid levels in subjects with chronic periodontitis and hyperlipidemia. Chin J Dent Res. 2012;15(1):25-9.</citation>
    <PMID>22866279</PMID>
  </reference>
  <reference>
    <citation>Fentoglu O, Koroglu BK, Kara Y, Dogan B, Yilmaz G, Sutcu R, Ay ZY, Tonguc MO, Orhan H, Tamer MN, Kirzioglu FY. Serum lipoprotein-associated phospholipase A(2) and C-reactive protein levels in association with periodontal disease and hyperlipidemia. J Periodontol. 2011 Mar;82(3):350-9. doi: 10.1902/jop.2010.100417. Epub 2010 Sep 1.</citation>
    <PMID>20809860</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meenakshi Ammal Dental College and Hospital</investigator_affiliation>
    <investigator_full_name>Dr.Jaideep Mahendra</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>chronic periodontitis</keyword>
  <keyword>lipids</keyword>
  <keyword>Lp-PLA2</keyword>
  <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>
  <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/NCT03041480
org study id: MADC/IRB/2015/91
nct id: NCT03041480
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To assess the association between periodontal parameters, serum lipid profile and Lp-PLA2
      level in systemically healthy Chronic Periodontitis subjects and healthy controls.
Seventy five participants were divided into 3 groups. The groups consisted of GROUP I-
      generalized severe chronic periodontitis, GROUP II- generalized moderate chronic
      periodontitis and GROUP III- systemically and periodontally healthy volunteers who served as
      control. The selected patients were then evaluated for periodontal parameters, lipid profile
      and Lp-PLA2.
observational model: Case-Control
time perspective: Other
measure: Estimation of serum Lp-PLA2
time frame: 9 months
description: Serum Lp-PLA2 was estimated in all the groups using ELISA
measure: Estimation of serum lipid profile
time frame: 9 months
description: Serum Total cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein and very low density lipoprotein
arm group label: GROUP I
description: Estimation of serum lipid levels and Lp-PLA2 in generalized severe chronic periodontitis
arm group label: GROUP II
description: Estimation of serum lipid levels and Lp-PLA2 in generalized moderate chronic periodontitis
arm group label: GROUP III
description: Estimation of serum lipid levels and Lp-PLA2 in systemically and periodontally healthy controls
intervention type: Diagnostic Test
intervention name: serum lipid levels and Lp-PLA2
description: Estimation of Total Cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein, very low density lipoprotein and Lipoprotein associated lipophosphase A2 in chronic periodontitis
arm group label: GROUP I
arm group label: GROUP II
arm group label: GROUP III
other name: Biological marker
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bittu Koshy, BDS
role: Principal Investigator
affiliation: Meenakshi Ammal Dental College
citation: Zhou SY, Xiao WM, Ouyang XY. Lipoprotein-associated phospholipase A2 and serum lipid levels in subjects with chronic periodontitis and hyperlipidemia. Chin J Dent Res. 2012;15(1):25-9.
PMID: 22866279
citation: Fentoglu O, Koroglu BK, Kara Y, Dogan B, Yilmaz G, Sutcu R, Ay ZY, Tonguc MO, Orhan H, Tamer MN, Kirzioglu FY. Serum lipoprotein-associated phospholipase A(2) and C-reactive protein levels in association with periodontal disease and hyperlipidemia. J Periodontol. 2011 Mar;82(3):350-9. doi: 10.1902/jop.2010.100417. Epub 2010 Sep 1.
PMID: 20809860
responsible party type: Principal Investigator
investigator affiliation: Meenakshi Ammal Dental College and Hospital
investigator full name: Dr.Jaideep Mahendra
investigator title: Professor
mesh term: Periodontitis
mesh term: Chronic Periodontitis
sharing ipd: No