Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-03-05 @ 7:40 PM
Study NCT ID:
NCT06635369
Status:
COMPLETED
Last Update Posted:
2024-10-10
First Post:
2024-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taurine in Periodontitis and Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are separated into four different groups. Young (25-44 years) with a healthy periodontium, young with periodontitis, old (≥65 years) with a healthy periodontium, and old with periodontitis'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-09', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2024-10-09', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Taurine', 'timeFrame': '12 Weeks', 'description': 'Taurine levels in saliva and serum were measured'}, {'measure': 'SIRT1', 'timeFrame': '12 Weeks', 'description': 'SIRT1 levels in saliva and serum were measured'}, {'measure': 'TNF-α', 'timeFrame': '12 Weeks', 'description': 'TNF-α levels in saliva and serum were measured'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Taurine', 'Periodontitis', 'Aging', 'Inflammation', 'TNF-α', 'SIRT1', 'Biomarker'], 'conditions': ['Peridontal Disease', 'Aging']}, 'descriptionModule': {'briefSummary': 'Aging leads to a decline in physiological functions and increases the risk of chronic diseases. Periodontitis is a chronic inflammatory disease that causes progressive destruction of the tissues supporting the teeth. Taurine, an amino acid with anti-inflammatory and antioxidant effects, might impact both periodontitis and aging. This study investigated taurine, SIRT1, and TNF-α levels in saliva and blood of 66 healthy people in different age groups, with or without periodontal disease. The findings showed that young people with healthy periodontal status had higher levels of taurine and SIRT1 compared to others. TNF-α, a marker of inflammation, was linked to the severity of periodontitis and may help identifying it in younger individuals. Overall, higher TNF-α levels are associated with periodontal inflammation, while taurine levels decrease with age-related inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '26 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Exclusion Criteria:\n\n* ages 18-25 or 45-64\n* use of antibiotics, anti-inflammatory drugs, immunosuppressants, beta-blockers, calcium channel blockers, or anticoagulants within the last 6 months\n* presence of diabetes, rheumatoid arthritis, or other systemic conditions such as cardiovascular, renal, hepatic, and neurodegenerative disorders\n* pregnancy or lactation\n* alcoholism\n* smoking\n* nonsurgical periodontal treatment in the past 6 months or surgical treatment in the past 12 months\n* having less than 20 natural teeth, excluding third molars\n* use of orthodontic appliances'}, 'identificationModule': {'nctId': 'NCT06635369', 'briefTitle': 'Taurine in Periodontitis and Aging', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'The Role of Taurine in Periodontitis and Aging: a Preliminary Study', 'orgStudyIdInfo': {'id': '1078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Young (25-44 years) with a healthy periodontium', 'interventionNames': ['Diagnostic Test: Periodontal Indices']}, {'type': 'EXPERIMENTAL', 'label': 'young (25-44 years) with Periodontitis', 'interventionNames': ['Diagnostic Test: Periodontal Indices']}, {'type': 'EXPERIMENTAL', 'label': 'Old (≥65 years) with a healthy periodontium', 'interventionNames': ['Diagnostic Test: Periodontal Indices']}, {'type': 'EXPERIMENTAL', 'label': 'Old (≥65 years) with Periodontitis', 'interventionNames': ['Diagnostic Test: Periodontal Indices']}], 'interventions': [{'name': 'Periodontal Indices', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Salivary Flow Rate', 'TNF-α Levels', 'SIRT1 Levels', 'Taurine Levels'], 'description': 'Saliva, serum and periodontal indexes were obtained from patients', 'armGroupLabels': ['Old (≥65 years) with Periodontitis', 'Old (≥65 years) with a healthy periodontium', 'Young (25-44 years) with a healthy periodontium', 'young (25-44 years) with Periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Unkapani', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to patients data privacy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd candidate', 'investigatorFullName': 'Hadi Sayedyousef', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}