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Effect of Pranayama on Periodontal Health

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ClinicalTrials.gov Identifier: NCT02967861
Recruitment Status : Completed
First Posted : November 18, 2016
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Behavioral: Pranayama Procedure: Scaling and root planing Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Active Comparator: SRP & pranayama (lifestyle modification)
30 chronic periodontitis subjects treated with SRP & pranayama for 3 months
Behavioral: Pranayama
Pranayama is the breathing exercise through the nostrils. It enhances the systemic immunity which in turn enhances the overall defense mechanism of an individual.

Placebo Comparator: Scaling and root planing
30 chronic periodontitis subjects treated with scaling and root planing only
Procedure: Scaling and root planing
It is a mechanical debridement of dental plaque.




Primary Outcome Measures :
  1. Clinical efficacy of pranayama in chronic periodontitis patients from baseline to 3 months [ Time Frame: 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 :
  1. Microbiological efficacy of pranayama in chronic periodontitis patients from baseline to 3 months [ Time Frame: 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.

  2. Efficacy of pranayama on nuclear factor-kappa B (NF-kB) in chronic periodontitis patients [ Time Frame: 3 months ]
    The expression of NF-kB is analysed using Real time PCR after isolation of RNA from subgingival plaque samples.

  3. Efficacy of pranayama on perosxisome proliferator-activated receptor (PPAR)-γ in chronic periodontitis patients [ Time Frame: 3 months ]
    The expression of PPAR- γ is analysed using Real time PCR after isolation of RNA from subgingival plaque samples.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967861


Sponsors and Collaborators
Meenakshi Ammal Dental College and Hospital
Investigators
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Principal Investigator: Jaideep Mahendra, MDS, Ph.D Meenakshi Ammal Dental College & Hospital

Publications of Results:
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Responsible Party: Dr.Jaideep Mahendra, Professor, Meenakshi Ammal Dental College and Hospital
ClinicalTrials.gov Identifier: NCT02967861     History of Changes
Other Study ID Numbers: MAHER-MU-002-IEC/2016
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital:
chronic periodontitis
Nuclear factor-kappa B
Pranayama
Peroxisome proliferator - activated receptor gamma
Red complex microorganisms

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases