Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-13 @ 9:46 AM
Study NCT ID:
NCT05325905
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2022-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Gingival Crevicular Fluid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Gingival crevicular fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin-36γ (IL-36γ) levels in GCF', 'timeFrame': 'Baseline', 'description': 'GCF samples were obtained from one interproximal site in each quadrant'}], 'secondaryOutcomes': [{'measure': 'Probing depth (PD)', 'timeFrame': 'Baseline', 'description': 'PD; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars.'}, {'measure': 'Clinical attachment level (CAL)', 'timeFrame': 'Baseline', 'description': 'CAL; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars.'}, {'measure': 'Bleeding on Probing (BoP)', 'timeFrame': 'Baseline', 'description': 'BoP, from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars'}, {'measure': 'IL-10 and IL-1β levels in GCF', 'timeFrame': 'Baseline', 'description': 'GCF samples were obtained from one interproximal site in each quadrant'}, {'measure': 'Plaque Index (PI)', 'timeFrame': 'Baseline', 'description': 'PI; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars'}, {'measure': 'Gingival Index (GI)', 'timeFrame': 'Baseline', 'description': 'GI; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pathogenesis', 'Gingival crevicular fluid', 'cytokine'], 'conditions': ['Periodontal Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status.', 'detailedDescription': 'Gingival crevicular fluid (GCF) is formed when fluid exudes from the vessels of the microcirculation into the inflamed periodontal tissue and into the sulcus or pocket. As the fluid traverses the inflamed tissue, it is thought to pick up enzymes and other molecules that participate in the destructive process, as well as products of cell and tissue degradation. Efforts to develop diagnostic tests based on host factors have been focused almost entirely on analysis of GCF.\n\nThe purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status.\n\nSystemically healthy and non-smokers 80 participants (30 males and 50 females) who were selected from among admitting to Dentistry Faculty of Selcuk University were included in this study. Clinical periodontal parameters were recorded and GCF samples were obtained. Samples were stored in -80 ˚C until analysis with Enzyme-Linked ImmunoSorbent Assay (ELISA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were selected from among admitting to Dentistry Faculty of Selcuk University.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy\n* non-smokers,\n* presence of at least 20 teeth in the mouth\n\nExclusion Criteria:\n\n* receiving periodontal therapy in the last 6 months;\n* receiving antibiotics or anti-inflammatory drugs in the last 6 months;\n* currently pregnant or breastfeeding\n* using a removable partial denture and removable or fixed orthodontic appliances.'}, 'identificationModule': {'nctId': 'NCT05325905', 'acronym': 'GCF', 'briefTitle': 'Analysis of Gingival Crevicular Fluid', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Analysis of Gingival Crevicular Fluid IL-1β, IL-10, IL-36γ Cytokine Levels in Gingivitis and Periodontitis Patients', 'orgStudyIdInfo': {'id': '2014/01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy', 'description': 'bleeding on probing (BoP) ≤ 10% of the sites, probing depth (PD) ≤ 3 mm and no indication of clinical attachment level (CAL) or radiographic bone loss', 'interventionNames': ['Diagnostic Test: Gingival crevicular fluid sampling']}, {'label': 'Gingivitis', 'description': 'gingival inflammation (BoP ≥ 10% of the sites, red-blue discoloration of the gingiva and edema) PD ≤ 4 mm and no clinical attachment or radiographic bone loss', 'interventionNames': ['Diagnostic Test: Gingival crevicular fluid sampling']}, {'label': 'Periodontitis', 'description': 'PD ≤ 5 mm, radiographic bone loss, and 3-4 mm CAL in at least 30% of the sites', 'interventionNames': ['Diagnostic Test: Gingival crevicular fluid sampling']}], 'interventions': [{'name': 'Gingival crevicular fluid sampling', 'type': 'DIAGNOSTIC_TEST', 'description': 'GCF sampling and clinical periodontal measurements were performed', 'armGroupLabels': ['Gingivitis', 'Healthy', 'Periodontitis']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mehtikar Gürsel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bezmialem University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Results will be shared if requested'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Selcuk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.Dr', 'investigatorFullName': 'Mehtikar Gursel', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}