Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02327533
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2014-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Expression Profiles in Generalized Aggressive Periodontitis: A Gene Network-based Microarray Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-06-18', 'releaseDate': '2015-06-03'}, {'resetDate': '2018-10-04', 'releaseDate': '2018-02-09'}], 'estimatedResultsFirstSubmitDate': '2015-06-03'}}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Biospecimens were kept for analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-24', 'studyFirstSubmitDate': '2014-12-17', 'studyFirstSubmitQcDate': '2014-12-24', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mRNA quantification', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Definition of gen networking and new molecular pathways', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['generalized aggressive periodontitis', 'microarray analysis'], 'conditions': ['Generalized Aggressive Periodontitis']}, 'referencesModule': {'references': [{'pmid': '16135066', 'type': 'BACKGROUND', 'citation': 'Kinane DF, Shiba H, Hart TC. The genetic basis of periodontitis. Periodontol 2000. 2005;39:91-117. doi: 10.1111/j.1600-0757.2005.00118.x. No abstract available.'}, {'pmid': '18980520', 'type': 'RESULT', 'citation': 'Demmer RT, Behle JH, Wolf DL, Handfield M, Kebschull M, Celenti R, Pavlidis P, Papapanou PN. Transcriptomes in healthy and diseased gingival tissues. J Periodontol. 2008 Nov;79(11):2112-24. doi: 10.1902/jop.2008.080139.'}, {'pmid': '15154918', 'type': 'RESULT', 'citation': 'Papapanou PN, Abron A, Verbitsky M, Picolos D, Yang J, Qin J, Fine JB, Pavlidis P. Gene expression signatures in chronic and aggressive periodontitis: a pilot study. Eur J Oral Sci. 2004 Jun;112(3):216-23. doi: 10.1111/j.1600-0722.2004.00124.x.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators evaluated molecular biomarkers which play a role in the development of generalized aggressive periodontitis (GAgP) using gingival tissue samples through omics-based whole-genome transcriptomic while using healthy individuals as background controls.', 'detailedDescription': 'Aggressive periodontitis (AgP) is an inflammatory periodontal disease which is complex, multifactorial, and destructive. Progression and severity of the disease depend on interacting risk factors such as: immunological, microbiological, environmental, and genetic factors, as well as age, sex, and race.Some patients are genetically predisposed to AgP; they have immunological abnormalities, which are thought to be under genetic control. However, high susceptibility for periodontal destruction and the relationship between inflammatory changes, and genetic factors remain unclear.\n\nGene expression profiling is a powerful means of generating comprehensive genome-level data sets on diseases such as cancer, asthma, rheumatoid disorders and periodontitis, and provides significant insight information for these diseases. Gene expression profiling may provide an evidence for involving genes in the pathogenesis of AgP and generate further information other than clinical signs and symptoms of AgP.\n\nThe aim of this study was to identify gene-expression patterns of patients with generalized aggressive periodontitis by whole-transcriptome gene-expression analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Aggressive periodontitis patients: The periodontal diagnosis of subjects with GAgP was established on the basis of clinical and radiographic criteria and was defined by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions.(Lang et al., 1999) Patients were included if they were between 18 and 35 years of age and otherwise healthy. The bone loss estimation was radiographically performed in each patient for the assessment of the extent and severity of alveolar bone loss.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The periodontal diagnosis of subjects with GAgP was established on the basis of clinical and radiographic criteria and was defined by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions.(Lang et al., 1999) Patients were included if they were between 18 and 35 years of age and otherwise healthy. The bone loss estimation was radiographically performed in each patient for the assessment of the extent and severity of alveolar bone loss.\n\nExclusion Criteria:\n\n* Subjects were excluded if they had any known systemic diseases or conditions that can/could influence the periodontal status (cancer, cardiovascular and respiratory diseases), any history of hepatitis and/or HIV infection, immunosuppressive chemotherapy, current pregnancy, planning a pregnancy or lactation, requirement for antibiotic prophylaxis, oral diseases other than GAgP, ongoing orthodontic therapy, a history of antibiotic therapy, or periodontal treatment within the preceding six months.'}, 'identificationModule': {'nctId': 'NCT02327533', 'briefTitle': 'Gene Expression Profiles in Generalized Aggressive Periodontitis: A Gene Network-based Microarray Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Gene Expression Profiles in Generalized Aggressive Periodontitis: A Gene Network-based Microarray Analysis', 'orgStudyIdInfo': {'id': 'KOU KAEK2013/15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Aggressive Periodontitis', 'description': 'The periodontal diagnosis of subjects with GAgP was established on the basis of clinical and radiographic criteria and was defined by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions.(Lang et al., 1999)'}, {'label': 'Controls', 'description': 'Control subjects had no radiographic evidence of bone loss or any sign of past and present periodontitis.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Esra Güzeldemir-Akçakanat, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kocaeli University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, PhD, Assoc. Prof.', 'investigatorFullName': 'Esra Guzeldemir-Akcakanat', 'investigatorAffiliation': 'Kocaeli University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-06-03', 'type': 'RELEASE'}, {'date': '2015-06-18', 'type': 'RESET'}, {'date': '2018-02-09', 'type': 'RELEASE'}, {'date': '2018-10-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Esra Guzeldemir-Akcakanat, DDS, PhD, Assoc. Prof., Kocaeli University'}}}}