NCT02967861

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2016

Shorter than P25 for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

November 8, 2016

Last Update Submit

November 15, 2016

Conditions

Chronic Periodontitis

Keywords

chronic periodontitisNuclear factor-kappa BPranayamaPeroxisome proliferator - activated receptor gammaRed complex microorganisms

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Microbiological efficacy of pranayama in chronic periodontitis patients from baseline to 3 months

    3 months

  • Efficacy of pranayama on nuclear factor-kappa B (NF-kB) in chronic periodontitis patients

    3 months

  • Efficacy of pranayama on perosxisome proliferator-activated receptor (PPAR)-γ in chronic periodontitis patients

    3 months

Study Arms (2)

SRP & pranayama (lifestyle modification)

ACTIVE COMPARATOR

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

Behavioral: Pranayama

Scaling and root planing

PLACEBO COMPARATOR

30 chronic periodontitis subjects treated with scaling and root planing only

Procedure: Scaling and root planing

Interventions

PranayamaBEHAVIORAL

Pranayama is the breathing exercise through the nostrils. It enhances the systemic immunity which in turn enhances the overall defense mechanism of an individual.

SRP & pranayama (lifestyle modification)
Scaling and root planingPROCEDURE

It is a mechanical debridement of dental plaque.

Scaling and root planing

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1146/annurev.immunol.14.1.649.

    PMID: 8717528RESULT

  • 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.

    PMID: 16185770RESULT

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Jaideep Mahendra, MDS, Ph.D

    Meenakshi Ammal Dental College & Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 18, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 18, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share