Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT06561802
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2024-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of GCF And Salivary Ferritin, ALP And MMP-8 Levels of Individuals With Different Periodontal Diseases
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2024-08-16', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total amount of Ferritin in GCF and saliva', 'timeFrame': '24 hours after taking the clinical measurements at the first visit'}, {'measure': 'The total amount of ALP in GCF and saliva', 'timeFrame': '24 hours after taking the clinical measurements at the first visit'}], 'secondaryOutcomes': [{'measure': 'The total amount of MMP-8 in GCF and saliva', 'timeFrame': '24 hours after taking the clinical measurements at the first visit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical study was to determine the levels of ferritin, alkaline phosphatase and matrix metalloproteinase-8 in the gingival crevicular fluid (GCF) and saliva samples were collected from 60 systemically healthy, non-smoker periodontitis (P group, n = 20), gingivitis (G group, n = 20) and periodontally healthy individuals (S group, n = 20) and all clinical parameters were recorded for all groups at baseline. GCF and serum samplings and clinical records were also repeated at 1st and 3rd months visitsfor only P group. Ferritin, MMP8, and ALP levels in samples were determined by enzyme-linked immunosorbent assay (ELISA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy\n* At least twenty permanent teeth in the mouth\n* Non-smoker\n* No medication for continuous use\n* Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.\n* Not in pregnancy or lactation period.\n* For the periodontitis group that has not received periodontal treatment in the last 6 months\n\n * For the periodontitis group; According to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss\n * For the gingivitis group; According to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss\n * For healthy group; According to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.\n\nExclusion Criteria:\n\n* Any oral or systemic disease\n* Regularly using a systemic medication\n* During pregnancy or lactation\n* Received periodontal treatment within the last 6 months.\n* Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months\n* Smokers are not included in the study'}, 'identificationModule': {'nctId': 'NCT06561802', 'briefTitle': 'Evaluation of GCF And Salivary Ferritin, ALP And MMP-8 Levels of Individuals With Different Periodontal Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Katip Celebi University'}, 'officialTitle': 'Evaluation Of Gingival Crevicular Fluid And Salivary Ferritin, Alkaline Phosphatase And Matrix Metalloproteinase-8 Levels Of Individuals With Different Periodontal Diseases', 'orgStudyIdInfo': {'id': '2019-TDR-SABE-0009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'periodontally healthy', 'description': 'Full-mouth clinical periodontal measurements recorded and GCF and saliva obtained.', 'interventionNames': ['Diagnostic Test: GCF and saliva obtaining']}, {'type': 'EXPERIMENTAL', 'label': 'gingivitis', 'description': 'Full-mouth clinical periodontal measurements recorded and GCF and saliva obtained.', 'interventionNames': ['Diagnostic Test: GCF and saliva obtaining']}, {'type': 'EXPERIMENTAL', 'label': 'periodontitis', 'description': 'Full-mouth clinical periodontal measurements recorded and GCF and saliva obtained.', 'interventionNames': ['Diagnostic Test: GCF and saliva obtaining']}], 'interventions': [{'name': 'GCF and saliva obtaining', 'type': 'DIAGNOSTIC_TEST', 'description': "The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Also, 4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips and put into propylene tube. Tubes were stored at -80ºC until the day of analysis.", 'armGroupLabels': ['gingivitis', 'periodontally healthy', 'periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35640', 'city': 'Izmir', 'state': 'Çiğli', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir Katip Çelebi University Department of Periodontology', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Katip Celebi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Erim Bozkurt', 'investigatorAffiliation': 'Izmir Katip Celebi University'}}}}