Effect of Pranayama on Periodontal Health

Early Phase 1

Completed

• Conditions: Chronic Periodontitis
• Interventions: Behavioral: Pranayama; Procedure: Scaling and root planing

• Registration Number: NCT02967861
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-01
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-11
• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-15
• Last Update Submitted: 2016-11-15
• Study First Posted: 2016-11-18
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SRP & pranayama (lifestyle modification)	Pranayama	30 chronic periodontitis subjects treated with SRP \& pranayama for 3 months
Scaling and root planing	Scaling and root planing	30 chronic periodontitis subjects treated with scaling and root planing only

Primary Outcome Measures

Name	Time	Method
Clinical efficacy of pranayama in chronic periodontitis patients from baseline to 3 months	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

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