Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT06554756
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2024-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Annexin Levels of Periodontal Inflammatory Regulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Saliva, serum and gingival crevicular fluid of periodontitis patients collected for analyzing anxa1, anxa2 and IL-1beta'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2024-08-12', 'studyFirstSubmitQcDate': '2024-08-12', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pocket probing depth', 'timeFrame': '6 months', 'description': 'Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.'}, {'measure': 'Clinical attachment level', 'timeFrame': '6 months', 'description': 'Clinical attachment level (or loss, CAL) is a more accurate indicator of the periodontal support around a tooth than probing depth alone. CAL is measured from a fixed point on the tooth that does not change, the CEJ.\n\nTo calculate CAL, two measurements are needed: distance from the gingival margin to the CEJ and probing depth.\n\nIn recession: probing depth (+) gingival margin to the CEJ (add). In tissue overgrowth: probing depth (-) gingival margin to the CEJ (subtract)'}, {'measure': 'Bleeding on probing', 'timeFrame': '6 months', 'description': 'referring to bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.'}], 'secondaryOutcomes': [{'measure': 'Saliva, serum and GCF samples processing and analyses', 'timeFrame': '1 month', 'description': 'Saliva, GCF and serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for ANXA1, ANXA2 and IL-1beta using commercial ELISA kits'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periodontal disease', 'annexin'], 'conditions': ['Periodontal Diseases', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '39572681', 'type': 'DERIVED', 'citation': 'Yilmaz M, Bal I, Hanli S, Turkmen E, Balci N, Toygar HU. Annexin levels in GCF determine the imbalance of periodontal inflammatory regulation. Sci Rep. 2024 Nov 21;14(1):28833. doi: 10.1038/s41598-024-80418-x.'}]}, 'descriptionModule': {'briefSummary': 'ANXA1, a member of the annexin family, plays a role in the resolution of inflammation and the regulation of anti-inflammatory responses, while ANXA2 is involved in the initiation of the inflammatory responses. The aim of this study was to determine the effects of annexin family (ANXA1 and ANXA2) in periodontal disease.', 'detailedDescription': 'Healthy participants (n:25) and stage III, grade B periodontitis (n:25) patients enrolled for this study. Clinical periodontal parameters and PISA levels were noted. Serum, saliva, and GCF samples were collected to measure the ANXA1, ANXA2 and IL-1β levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nsystemically healthy\n\n* clinical diagnosis of periodontitis\n* clinical diagnosis of periodontal health\n\nExclusion Criteria:\n\n* • history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)\n\n * nonsurgical periodontal treatment (previous 6 months)\n * surgical periodontal treatment (previous 12 months)\n * presence of\\<10 teeth\n * current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)\n * diabetes\n * diagnosis of rheumatoid arthritis\n * pregnancy\n * lactating\n * smoking\n * excessive alcohol consumption.'}, 'identificationModule': {'nctId': 'NCT06554756', 'briefTitle': 'Annexin Levels of Periodontal Inflammatory Regulation', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Annexin Levels in GCF Determine the Imbalance of Periodontal Inflammatory Regulation', 'orgStudyIdInfo': {'id': '635'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Active Comparator', 'description': 'Saliva, serum and GCF collection of patients and samples molecules analysis', 'interventionNames': ['Other: Saliva, serum and GCF sampling']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': "Salivary, serum and GCF ANXA1, ANXA2 and IL-1beta observation Saliva, serum and GCF samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for ANXA1, ANXA2 and IL-1beta using commercial ELISA kits (Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions.", 'interventionNames': ['Other: Saliva, serum and GCF sampling']}], 'interventions': [{'name': 'Saliva, serum and GCF sampling', 'type': 'OTHER', 'description': 'Saliva were collected to analyze the selected markers as unstimulated samples during the early hours of the day. The saliva was centrifuged and then transferred into Eppendorf tubes. Venous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff from each participant. Gingival crevicular fluid (GCF) samples were taken from the vestibular, mesial, and distal surfaces of a single-rooted tooth with standard paper strips (Periopaper, Oraflow Inc., Plainview, NY, USA). Saliva, GCF and serum were then stored at -80 °C until analysis.', 'armGroupLabels': ['Active Comparator', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University, School of Dentistry', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Prof Dr', 'investigatorFullName': 'Melis Yilmaz', 'investigatorAffiliation': 'Medipol University'}}}}