Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04958005
Status:
COMPLETED
Last Update Posted:
2021-10-21
First Post:
2021-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Salivary Interleukin-32, Interleukin-10, Interleukin-6 and Tumor Necrosis Factor-alpha Levels in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IL-32', 'timeFrame': 'Baseline', 'description': 'Interleukin- 32 level'}, {'measure': 'IL-10', 'timeFrame': 'Baseline', 'description': 'Interleukin- 10 level'}], 'secondaryOutcomes': [{'measure': 'IL-6', 'timeFrame': 'Baseline', 'description': 'Interleukin- 6 level'}, {'measure': 'Tnf-Alpha', 'timeFrame': 'Baseline', 'description': 'Tnf-alpha level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early childhood caries'], 'conditions': ['Early Childhood Caries']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the levels of interleukin 10, interleukin 6, interleukin 32 and tumor necrosis factor-alpha (TNF-α) in saliva of children with early childhood caries.', 'detailedDescription': 'Fifty six children ( 28 with early childhood caries and 28 without early childhood caries ; age range 3-6 years) will be recruited for the study. Probing pocket depth (PPD), gingival index (GI) and plaque index (PI) will be recorded and saliva samples will be collected. Interleukin-32, Interleukin-10, Interleukin-6 and TNF-α will be analyzed in saliva samples by ELISA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '70 Months', 'minimumAge': '3 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '28 children with early childhood caries and 28 children without caries will be collected.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with untreated early chilhood caries\n* Age between 3 and 6 years\n\nExclusion Criteria:\n\n* Having a systemic problem or mental retardation\n* Children with treated caries'}, 'identificationModule': {'nctId': 'NCT04958005', 'briefTitle': 'Salivary Interleukin-32, Interleukin-10, Interleukin-6 and Tumor Necrosis Factor-alpha Levels in Children', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Evaluation of Salivary Interleukin-32, Interleukin-10, Interleukin-6 and Tumor Necrosis Factor-alpha Levels in Children With Early Childhood Caries.', 'orgStudyIdInfo': {'id': '2020/190'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with early chilhood caries', 'description': 'Early chilhood caries group', 'interventionNames': ['Diagnostic Test: ELISA']}, {'label': 'Without early chilhood caries', 'description': 'Control group', 'interventionNames': ['Diagnostic Test: ELISA']}], 'interventions': [{'name': 'ELISA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Enzim linked immunoabsorbant assay', 'armGroupLabels': ['Children with early chilhood caries', 'Without early chilhood caries']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09100', 'city': 'Aydin', 'country': 'Turkey (Türkiye)', 'facility': 'Sultan KELEŞ', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof.Dr.', 'investigatorFullName': 'Sultan KELES', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}