Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-03 @ 6:15 AM
Study NCT ID:
NCT03910205
Status:
COMPLETED
Last Update Posted:
2019-11-29
First Post:
2019-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus
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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-27', 'studyFirstSubmitDate': '2019-04-09', 'studyFirstSubmitQcDate': '2019-04-09', 'lastUpdatePostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin-18 level', 'timeFrame': 'Baseline', 'description': 'IL-18'}], 'secondaryOutcomes': [{'measure': 'Tnf-alpha level', 'timeFrame': 'Baseline', 'description': 'Tnf-Alpha'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['interleukin-18', 'gingival crevicular fluid', 'tumor necrosis factor alpha'], 'conditions': ['Periodontal Diseases']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the levels of interleukin 18 and tumor necrosis factor-alpha (TNF-α) in gingival crevicular fluid (GCF) of children with type 1 diabetes mellitus and gingivitis.', 'detailedDescription': 'Eighty eight children (44 with type 1 diabetes mellitus and 44 healty; age range 7-14 years) will be recruited for the study. The children will be classified into four subgroups based on their periodontal status; 1) Children with gingivitis and diabetes mellitus (MG, n=22); 2) Children with type 1 diabetes mellitus with healthy periodontium (MH, n=22); 3)Healthy children with gingivitis (HG, n=22); 4) Healthy children with healthy periodontium (HH, n=22). Probing pocket depth (PPD), gingival index (GI) and plaque index (PI) will be recorded. Interleukin-18 and TNF-α will be analyzed in GCF and saliva samples by ELISA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '88 Children with diabetes mellitus and systemically healty children with and without gingivitis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children diagnosed as type 1 diabetes mellitus\n* Age between 7 and 14 years\n\nExclusion Criteria:\n\n* Having another systemic problem except type 1 diabetes mellitus\n* Children carrying orthodontic appliances'}, 'identificationModule': {'nctId': 'NCT03910205', 'briefTitle': 'Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Gingival Crevicular Fluid Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '2019-062'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 1 diabetes with gingivitis', 'description': 'Children with type 1 diabetes mellitus and gingivitis', 'interventionNames': ['Diagnostic Test: ELISA']}, {'label': 'Type 1 diabetes with healthy gingiva', 'description': 'Children with type 1 diabetes mellitus and healthy gingiva', 'interventionNames': ['Diagnostic Test: ELISA']}, {'label': 'Healthy patients with gingivitis', 'description': 'Systemically healthy patients with gingivitis', 'interventionNames': ['Diagnostic Test: ELISA']}, {'label': 'Healthy patients with healthy gingiva', 'description': 'Systemically healthy patients with healthy gingiva', 'interventionNames': ['Diagnostic Test: ELISA']}], 'interventions': [{'name': 'ELISA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Enzim linked immunoabsorbant assay', 'armGroupLabels': ['Healthy patients with gingivitis', 'Healthy patients with healthy gingiva', 'Type 1 diabetes with gingivitis', 'Type 1 diabetes with healthy gingiva']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09100', 'city': 'Aydin', 'country': 'Turkey (Türkiye)', 'facility': 'Sultan KELES', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}], 'overallOfficials': [{'name': 'Sultan KELES, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof.Dr.', 'investigatorFullName': 'Sultan KELES', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}