Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-27 @ 9:10 PM
Study NCT ID:
NCT02967861
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2016-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pranayama on Periodontal Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-15', 'studyFirstSubmitDate': '2016-11-08', 'studyFirstSubmitQcDate': '2016-11-15', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical efficacy of pranayama in chronic periodontitis patients from baseline to 3 months', 'timeFrame': '3 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Microbiological efficacy of pranayama in chronic periodontitis patients from baseline to 3 months', 'timeFrame': '3 months', 'description': "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."}, {'measure': 'Efficacy of pranayama on nuclear factor-kappa B (NF-kB) in chronic periodontitis patients', 'timeFrame': '3 months', 'description': 'The expression of NF-kB is analysed using Real time PCR after isolation of RNA from subgingival plaque samples.'}, {'measure': 'Efficacy of pranayama on perosxisome proliferator-activated receptor (PPAR)-γ in chronic periodontitis patients', 'timeFrame': '3 months', 'description': 'The expression of PPAR- γ is analysed using Real time PCR after isolation of RNA from subgingival plaque samples.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic periodontitis', 'Nuclear factor-kappa B', 'Pranayama', 'Peroxisome proliferator - activated receptor gamma', 'Red complex microorganisms'], 'conditions': ['Chronic Periodontitis']}, 'referencesModule': {'references': [{'pmid': '8717528', 'type': 'RESULT', 'citation': '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': '16185770', 'type': 'RESULT', '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. doi: 10.1016/j.jad.2005.08.013. Epub 2005 Sep 26.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of at least 20 teeth\n* Probing pocket depth ≥ 5 mm\n\nExclusion Criteria:\n\n* aggressive periodontitis\n* systemic disorders\n* pregnant \\& lactating females\n* smokers \\& alcoholics\n* immunocompromised individuals'}, 'identificationModule': {'nctId': 'NCT02967861', 'briefTitle': 'Effect of Pranayama on Periodontal Health', 'organization': {'class': 'OTHER', 'fullName': 'Meenakshi Ammal Dental College and Hospital'}, 'officialTitle': 'Effect of Pranayama on Peroxisome Proliferator-activated Receptor Gamma, Nuclear Factor Kappa B and Red Complex Microorganisms in Patients With Chronic Periodontitis', 'orgStudyIdInfo': {'id': 'MAHER-MU-002-IEC/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SRP & pranayama (lifestyle modification)', 'description': '30 chronic periodontitis subjects treated with SRP \\& pranayama for 3 months', 'interventionNames': ['Behavioral: Pranayama']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Scaling and root planing', 'description': '30 chronic periodontitis subjects treated with scaling and root planing only', 'interventionNames': ['Procedure: Scaling and root planing']}], 'interventions': [{'name': 'Pranayama', 'type': 'BEHAVIORAL', 'description': 'Pranayama is the breathing exercise through the nostrils. It enhances the systemic immunity which in turn enhances the overall defense mechanism of an individual.', 'armGroupLabels': ['SRP & pranayama (lifestyle modification)']}, {'name': 'Scaling and root planing', 'type': 'PROCEDURE', 'description': 'It is a mechanical debridement of dental plaque.', 'armGroupLabels': ['Scaling and root planing']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jaideep Mahendra, MDS, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meenakshi Ammal Dental College & Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meenakshi Ammal Dental College and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr.Jaideep Mahendra', 'investigatorAffiliation': 'Meenakshi Ammal Dental College and Hospital'}}}}