<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/NCT02967861</url>
  </required_header>
  <id_info>
    <org_study_id>MAHER-MU-002-IEC/2016</org_study_id>
    <nct_id>NCT02967861</nct_id>
  </id_info>
  <brief_title>Effect of Pranayama on Periodontal Health</brief_title>
  <official_title>Effect of Pranayama on Peroxisome Proliferator-activated Receptor Gamma, Nuclear Factor Kappa B and Red Complex Microorganisms in Patients With Chronic Periodontitis</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study was to evaluate the levels of Peroxisome proliferator-activated&#xD;
      receptor gamma (PPAR-γ), Nuclear factor-kappa B (NF-kB) and the presence of red complex&#xD;
      microorganisms (RCM) such as Treponema denticola (T.d), Porphyromonas gingivalis (P.g) and&#xD;
      Tannerella forsythia (T.f) in the subgingival tissues of chronic periodontitis subjects&#xD;
      before and after intervention with pranayama as an adjunct to scaling and root planing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty chronic periodontitis subjects were selected out of which 30 subjects (control group)&#xD;
      were treated with scaling and root planing (SRP) and 30 subjects (pranayama group) also&#xD;
      underwent SRP and pranayama for 3 months. Clinical parameters were recorded and the presence&#xD;
      of PPAR-γ, NF-kB and RCM were assessed at baseline and after 3 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>Early Phase 1</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical efficacy of pranayama in chronic periodontitis patients from baseline to 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Clinical attachment level is measured using Williams periodontal probe in millimeters with the criteria of 1 to 2 mm for slight periodontitis, 3 to 4 mm for moderate periodontits and greater or equal to 5 mm for severe periodontitis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microbiological efficacy of pranayama in chronic periodontitis patients from baseline to 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Red complex microorganisms such as P.gingivalis, T.denticola, T.forsythia are identified as '0' for absence and '1' for presence and analysed using polymerase chain reaction from subgingival plaque samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of pranayama on nuclear factor-kappa B (NF-kB) in chronic periodontitis patients</measure>
    <time_frame>3 months</time_frame>
    <description>The expression of NF-kB is analysed using Real time PCR after isolation of RNA from subgingival plaque samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of pranayama on perosxisome proliferator-activated receptor (PPAR)-γ in chronic periodontitis patients</measure>
    <time_frame>3 months</time_frame>
    <description>The expression of PPAR- γ is analysed using Real time PCR after isolation of RNA from subgingival plaque samples.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>SRP &amp; pranayama (lifestyle modification)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 chronic periodontitis subjects treated with SRP &amp; pranayama for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Scaling and root planing</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30 chronic periodontitis subjects treated with scaling and root planing only</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pranayama</intervention_name>
    <description>Pranayama is the breathing exercise through the nostrils. It enhances the systemic immunity which in turn enhances the overall defense mechanism of an individual.</description>
    <arm_group_label>SRP &amp; pranayama (lifestyle modification)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Scaling and root planing</intervention_name>
    <description>It is a mechanical debridement of dental plaque.</description>
    <arm_group_label>Scaling and root planing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of at least 20 teeth&#xD;
&#xD;
          -  Probing pocket depth ≥ 5 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  aggressive periodontitis&#xD;
&#xD;
          -  systemic disorders&#xD;
&#xD;
          -  pregnant &amp; lactating females&#xD;
&#xD;
          -  smokers &amp; alcoholics&#xD;
&#xD;
          -  immunocompromised individuals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaideep Mahendra, MDS, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meenakshi Ammal Dental College &amp; Hospital</affiliation>
  </overall_official>
  <results_reference>
    <citation>Baldwin AS Jr. The NF-kappa B and I kappa B proteins: new discoveries and insights. Annu Rev Immunol. 1996;14:649-83. doi: 10.1146/annurev.immunol.14.1.649.</citation>
    <PMID>8717528</PMID>
  </results_reference>
  <results_reference>
    <citation>Pilkington K, Kirkwood G, Rampes H, Richardson J. Yoga for depression: the research evidence. J Affect Disord. 2005 Dec;89(1-3):13-24. doi: 10.1016/j.jad.2005.08.013. Epub 2005 Sep 26.</citation>
    <PMID>16185770</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 15, 2016</last_update_submitted>
  <last_update_submitted_qc>November 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</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>Nuclear factor-kappa B</keyword>
  <keyword>Pranayama</keyword>
  <keyword>Peroxisome proliferator - activated receptor gamma</keyword>
  <keyword>Red complex microorganisms</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/NCT02967861
org study id: MAHER-MU-002-IEC/2016
nct id: NCT02967861
lead sponsor: 
has dmc: Yes
The objective of the study was to evaluate the levels of Peroxisome proliferator-activated
      receptor gamma (PPAR-γ), Nuclear factor-kappa B (NF-kB) and the presence of red complex
      microorganisms (RCM) such as Treponema denticola (T.d), Porphyromonas gingivalis (P.g) and
      Tannerella forsythia (T.f) in the subgingival tissues of chronic periodontitis subjects
      before and after intervention with pranayama as an adjunct to scaling and root planing.
Sixty chronic periodontitis subjects were selected out of which 30 subjects (control group)
      were treated with scaling and root planing (SRP) and 30 subjects (pranayama group) also
      underwent SRP and pranayama for 3 months. Clinical parameters were recorded and the presence
      of PPAR-γ, NF-kB and RCM were assessed at baseline and after 3 months
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Clinical efficacy of pranayama in chronic periodontitis patients from baseline to 3 months
time frame: 3 months
description: Clinical attachment level is measured using Williams periodontal probe in millimeters with the criteria of 1 to 2 mm for slight periodontitis, 3 to 4 mm for moderate periodontits and greater or equal to 5 mm for severe periodontitis.
measure: Microbiological efficacy of pranayama in chronic periodontitis patients from baseline to 3 months
time frame: 3 months
description: Red complex microorganisms such as P.gingivalis, T.denticola, T.forsythia are identified as '0' for absence and '1' for presence and analysed using polymerase chain reaction from subgingival plaque samples.
measure: Efficacy of pranayama on nuclear factor-kappa B (NF-kB) in chronic periodontitis patients
time frame: 3 months
description: The expression of NF-kB is analysed using Real time PCR after isolation of RNA from subgingival plaque samples.
measure: Efficacy of pranayama on perosxisome proliferator-activated receptor (PPAR)-γ in chronic periodontitis patients
time frame: 3 months
description: The expression of PPAR- γ is analysed using Real time PCR after isolation of RNA from subgingival plaque samples.
arm group label: SRP & pranayama (lifestyle modification)
arm group type: Active Comparator
description: 30 chronic periodontitis subjects treated with SRP & pranayama for 3 months
arm group label: Scaling and root planing
arm group type: Placebo Comparator
description: 30 chronic periodontitis subjects treated with scaling and root planing only
intervention type: Behavioral
intervention name: Pranayama
description: Pranayama is the breathing exercise through the nostrils. It enhances the systemic immunity which in turn enhances the overall defense mechanism of an individual.
arm group label: SRP & pranayama (lifestyle modification)
intervention type: Procedure
intervention name: Scaling and root planing
description: It is a mechanical debridement of dental plaque.
arm group label: Scaling and root planing
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jaideep Mahendra, MDS, Ph.D
role: Principal Investigator
affiliation: Meenakshi Ammal Dental College & Hospital
citation: Baldwin AS Jr. The NF-kappa B and I kappa B proteins: new discoveries and insights. Annu Rev Immunol. 1996;14:649-83. doi: 10.1146/annurev.immunol.14.1.649.
PMID: 8717528
citation: Pilkington K, Kirkwood G, Rampes H, Richardson J. Yoga for depression: the research evidence. J Affect Disord. 2005 Dec;89(1-3):13-24. doi: 10.1016/j.jad.2005.08.013. Epub 2005 Sep 26.
PMID: 16185770
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