Effect of Pranayama on Periodontal Health

November 15, 2016 updated by: Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

Effect of Pranayama on Peroxisome Proliferator-activated Receptor Gamma, Nuclear Factor Kappa B and Red Complex Microorganisms in Patients With Chronic Periodontitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meenakshi Ammal Dental College and Hospital

Investigators

  • Principal Investigator: Jaideep Mahendra, MDS, Ph.D, Meenakshi Ammal Dental College & Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAHER-MU-002-IEC/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe