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Effect of Pranayama on Periodontal Health

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Pranayama
Scaling and root planing
Sponsored by
Meenakshi Ammal Dental College and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring chronic periodontitis, Nuclear factor-kappa B, Pranayama, Peroxisome proliferator - activated receptor gamma, Red complex microorganisms

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • presence of at least 20 teeth
  • Probing pocket depth ≥ 5 mm

Exclusion Criteria:

  • aggressive periodontitis
  • systemic disorders
  • pregnant & lactating females
  • smokers & alcoholics
  • immunocompromised individuals

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    SRP & pranayama (lifestyle modification)

    Scaling and root planing

    Arm Description

    30 chronic periodontitis subjects treated with SRP & pranayama for 3 months

    30 chronic periodontitis subjects treated with scaling and root planing only

    Outcomes

    Primary Outcome Measures

    Clinical efficacy of pranayama in chronic periodontitis patients from baseline to 3 months
    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.

    Secondary Outcome Measures

    Microbiological efficacy of pranayama in chronic periodontitis patients from baseline to 3 months
    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.
    Efficacy of pranayama on nuclear factor-kappa B (NF-kB) in chronic periodontitis patients
    The expression of NF-kB is analysed using Real time PCR after isolation of RNA from subgingival plaque samples.
    Efficacy of pranayama on perosxisome proliferator-activated receptor (PPAR)-γ in chronic periodontitis patients
    The expression of PPAR- γ is analysed using Real time PCR after isolation of RNA from subgingival plaque samples.

    Full Information

    First Posted
    November 8, 2016
    Last Updated
    November 15, 2016
    Sponsor
    Meenakshi Ammal Dental College and Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02967861
    Brief Title
    Effect of Pranayama on Periodontal Health
    Official Title
    Effect of Pranayama on Peroxisome Proliferator-activated Receptor Gamma, Nuclear Factor Kappa B and Red Complex Microorganisms in Patients With Chronic Periodontitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Meenakshi Ammal Dental College and Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    chronic periodontitis, Nuclear factor-kappa B, Pranayama, Peroxisome proliferator - activated receptor gamma, Red complex microorganisms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SRP & pranayama (lifestyle modification)
    Arm Type
    Active Comparator
    Arm Description
    30 chronic periodontitis subjects treated with SRP & pranayama for 3 months
    Arm Title
    Scaling and root planing
    Arm Type
    Placebo Comparator
    Arm Description
    30 chronic periodontitis subjects treated with scaling and root planing only
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pranayama
    Intervention 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Scaling and root planing
    Intervention Description
    It is a mechanical debridement of dental plaque.
    Primary Outcome Measure Information:
    Title
    Clinical efficacy of pranayama in chronic periodontitis patients from baseline to 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.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Microbiological efficacy of pranayama in chronic periodontitis patients from baseline to 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.
    Time Frame
    3 months
    Title
    Efficacy of pranayama on nuclear factor-kappa B (NF-kB) in chronic periodontitis patients
    Description
    The expression of NF-kB is analysed using Real time PCR after isolation of RNA from subgingival plaque samples.
    Time Frame
    3 months
    Title
    Efficacy of pranayama on perosxisome proliferator-activated receptor (PPAR)-γ in chronic periodontitis patients
    Description
    The expression of PPAR- γ is analysed using Real time PCR after isolation of RNA from subgingival plaque samples.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: presence of at least 20 teeth Probing pocket depth ≥ 5 mm Exclusion Criteria: aggressive periodontitis systemic disorders pregnant & lactating females smokers & alcoholics immunocompromised individuals
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jaideep Mahendra, MDS, Ph.D
    Organizational Affiliation
    Meenakshi Ammal Dental College & Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    8717528
    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.
    Results Reference
    result
    PubMed Identifier
    16185770
    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.
    Results Reference
    result

    Learn more about this trial

    Effect of Pranayama on Periodontal Health

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