Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-03-09 @ 7:49 AM
Study NCT ID:
NCT02423304
Status:
UNKNOWN
Last Update Posted:
2015-04-22
First Post:
2015-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serological Evaluation of 77A/G and 11A/12A Gene of MMP-13 in Periodontitis Affected and Healthy Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-21', 'studyFirstSubmitDate': '2015-04-17', 'studyFirstSubmitQcDate': '2015-04-21', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate the association of 77A/G AND 11A/12A gene polymorphism of mmp-13 in periodontitis effected and healthy individuals', 'timeFrame': '6 months', 'description': 'collect DNA samples from serum and evaluate for gene polymorphism'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Generalized Adult Periodontitis']}, 'referencesModule': {'references': [{'pmid': '19453573', 'type': 'BACKGROUND', 'citation': 'Pirhan D, Atilla G, Emingil G, Tervahartiala T, Sorsa T, Berdeli A. MMP-13 promoter polymorphisms in patients with chronic periodontitis: effects on GCF MMP-13 levels and outcome of periodontal therapy. J Clin Periodontol. 2009 Jun;36(6):474-81. doi: 10.1111/j.1600-051X.2009.01399.x. Epub 2009 Apr 22.'}, {'pmid': '9626053', 'type': 'RESULT', 'citation': 'Uitto VJ, Airola K, Vaalamo M, Johansson N, Putnins EE, Firth JD, Salonen J, Lopez-Otin C, Saarialho-Kere U, Kahari VM. Collagenase-3 (matrix metalloproteinase-13) expression is induced in oral mucosal epithelium during chronic inflammation. Am J Pathol. 1998 Jun;152(6):1489-99.'}, {'pmid': '11940142', 'type': 'RESULT', 'citation': 'Kiili M, Cox SW, Chen HY, Wahlgren J, Maisi P, Eley BM, Salo T, Sorsa T. Collagenase-2 (MMP-8) and collagenase-3 (MMP-13) in adult periodontitis: molecular forms and levels in gingival crevicular fluid and immunolocalisation in gingival tissue. J Clin Periodontol. 2002 Mar;29(3):224-32. doi: 10.1034/j.1600-051x.2002.290308.x.'}, {'pmid': '19929954', 'type': 'RESULT', 'citation': 'Hernandez Rios M, Sorsa T, Obregon F, Tervahartiala T, Valenzuela MA, Pozo P, Dutzan N, Lesaffre E, Molas M, Gamonal J. Proteolytic roles of matrix metalloproteinase (MMP)-13 during progression of chronic periodontitis: initial evidence for MMP-13/MMP-9 activation cascade. J Clin Periodontol. 2009 Dec;36(12):1011-7. doi: 10.1111/j.1600-051X.2009.01488.x.'}]}, 'descriptionModule': {'briefSummary': '50 periodontitis 50 healthy individuals serological evaluation will done to see association of 77A/G AND 11A/12A gene polymorphisms of MMP-13', 'detailedDescription': '* The study will be conducted on 100 individuals\n* 50 chronic periodontitis and 50 healthy individuals will be recruited from the Out Patient Department of Periodontics in the study.\n* An informed consent will be obtained from patients who wish to participate in the study.\n* Patients will be categorized by Periodontal Disease Index (PDI) by P. Ramfjord(1959)\n* After clinical examination, blood samples will be collected and assessed for MMP 13 Gene Polymorphisms.\n* Subjects will be selected according to the study criteria and divided into two groups (50 each).\n\n 1. Test group\n 2. Control group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* The study will be conducted on 100 individuals\n* 50 chronic periodontitis and 50 healthy individuals will be recruited from the Out Patient Department of Periodontics in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:• Test group\n\n1. Patients with chronic periodontitis classified according to American Academy of Periodontology ( AAP) 1999\n2. Subjects aged between 30-55 years\n\n * Control group Systemically and periodontally healthy individuals of same age group\n\nExclusion Criteria:\n\n1. Present and past Smokers\n2. Presence of any systemic diseases.\n3. Oral diseases other than Periodontitis\n4. With a previous history of periodontal treatment in the past 6 months and subjects under any medications.\n5. Family history of any diagnosed genetic disorders.'}, 'identificationModule': {'nctId': 'NCT02423304', 'acronym': 'SEGPPAH', 'briefTitle': 'Serological Evaluation of 77A/G and 11A/12A Gene of MMP-13 in Periodontitis Affected and Healthy Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre'}, 'officialTitle': 'A Serological Evaluation of 77A/G and 11A/12A Associated Gene Polymorphisms of MMP-13 in Periodontitis Affected and Healthy Individuals', 'orgStudyIdInfo': {'id': 'Divya Aiswairya thesis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'test', 'description': '50 periodontitis patients\n\n• Patients will be categorized by Periodontal Disease Index (PDI) by P. Ramfjord(1959) blood samples collected from all patients serum separated and evaluated for77A/G AND 11A/12A associated gene polymorphism of Matrix Metallo Proteinase( MMP)-13 in all the patients. studies showing that there is co relation of these genes with increase inflammation.', 'interventionNames': ['Genetic: blood samples collected from all patients']}, {'label': 'control', 'description': '50 periodontally healthy individuals blood samples collected from all patients serum separated and evaluated for77A/G AND 11A/12A associated gene polymorphism of Matrix Metallo Proteinase (MMP)-13 in all the patients', 'interventionNames': ['Genetic: blood samples collected from all patients']}], 'interventions': [{'name': 'blood samples collected from all patients', 'type': 'GENETIC', 'description': 'blood samples collected from brachial pluxes', 'armGroupLabels': ['control', 'test']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Institute for Genetic and Human Therapy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dr.M.Divya Aiswairya', 'investigatorFullName': 'J.surya prasanna', 'investigatorAffiliation': 'Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre'}}}}