Effect of Pranayama on Periodontal Health

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967861
• Other study ID #: MAHER-MU-002-IEC/2016
• Status: Completed
• Phase: Phase 0
• First received: November 8, 2016
• Last updated: November 15, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Meenakshi Ammal Dental College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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.

Procedure:
• Scaling and root planing
It is a mechanical debridement of dental plaque.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meenakshi Ammal Dental College and Hospital

References & Publications (2)

Baldwin AS Jr. The NF-kappa B and I kappa B proteins: new discoveries and insights. Annu Rev Immunol. 1996;14:649-83. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months	No
Secondary	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.	3 months	No
Secondary	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.	3 months	No
Secondary	Efficacy of pranayama on perosxisome proliferator-activated receptor (PPAR)-? in chronic periodontitis patients	The expression of PPAR- ? is analysed using Real time PCR after isolation of RNA from subgingival plaque samples.	3 months	No