Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-26 @ 7:30 AM
Study NCT ID:
NCT05417061
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2022-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Saliva and serum of periodontitis patients collected for analyzing SIRT6, LPXA4, CASP8'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2022-06-09', 'studyFirstSubmitQcDate': '2022-06-09', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-21', '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 and serum samples processing and analyses', 'timeFrame': '2 months', 'description': "Saliva and serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for Lipoxin A4 (LXA4), Caspase 8 (CASP8) and Sirtuin-6 (SIRT6) using commercial ELISA kits\n\n(Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inflammation resolution', 'periodontitis', 'cell apoptosis'], 'conditions': ['Periodontitis', 'Diagnose Disease']}, 'referencesModule': {'references': [{'pmid': '37851128', 'type': 'DERIVED', 'citation': 'Cekici A, Sahinkaya S, Donmez MF, Turkmen E, Balci N, Toygar H. Sirtuin6 and Lipoxin A4 levels are decreased in severe periodontitis. Clin Oral Investig. 2023 Dec;27(12):7407-7415. doi: 10.1007/s00784-023-05330-6. Epub 2023 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'It has been stated that Sirtuin-6 (SIRT6) play a important role in regulation of inflammation, energy metabolism, homeostasis and apoptosis, and SIRT6 may be assosiciated with many diseases. The aim of this study was to evaluate saliva and serum SIRT6, Lipoxin A4 (LXA4) and Caspase-8 (CASP8) levels in correlation with periodontal clinical status in patients with periodontitis and healthy subjects', 'detailedDescription': '20 patients with Stage III Grade B periodontitis (P) and 20 periodontally healthy individuals (control;C) were included in this study. Clinical periodontal parameters were measured. Saliva and serum levels of SIRT6, LXA4 and CASP8 were analyzed by enzyme-linked immunosorbent assay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systemically healthy\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* 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': 'NCT05417061', 'briefTitle': 'Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis', 'orgStudyIdInfo': {'id': '138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Saliva and serum collection of patients and samples molecules analysis', 'interventionNames': ['Other: Saliva and serum sampling']}, {'type': 'EXPERIMENTAL', 'label': 'Salivary and serum SIRT6, LPXA4 and CASP8 observation', 'description': "Saliva and serum samples obtained for each patient were used for cytokine analysis. Prepared samples were analyzed for Lipoxin A4 (LXA4), Caspase 8 (CASP8) and Sirtuin-6 (SIRT6) using commercial ELISA kits\n\n(Elabscience, Houston, Texas, USA and Bioaasay Technology Laboratory (BT-Lab), Shanghai, China, respectively) according to the manufacturer's instructions. The detection limits of ELISA kits were 0.78 - 50ng/ml for LXA4, 0.16 - 10ng/ml for CASP8 and 0.1- 40 ng/ml for SIRT6.", 'interventionNames': ['Other: Saliva and serum sampling']}], 'interventions': [{'name': 'Saliva and serum 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.\n\nVenous puncture was performed after saliva collection and 10 mL of blood samples were collected by qualified staff (MFD) from each participant. Saliva and serum were then stored at -80 °C until analysis.', 'armGroupLabels': ['Saliva and serum collection of patients and samples molecules analysis', 'Salivary and serum SIRT6, LPXA4 and CASP8 observation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34083', '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': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSOC. PROF DR', 'investigatorFullName': 'Nur Balci, DDs, PhD', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}