Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT05716867
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-17
First Post:
2023-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Salivary Cystatin S Levels in a Group of Egyptian Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'saliva samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2023-01-29', 'studyFirstSubmitQcDate': '2023-01-29', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of salivary cystatin S protein', 'timeFrame': '2 months', 'description': 'Levels of salivary cystatin S protein measured by Human cystatin S enzyme linked immunosorbent assay (ELISA) kit (unit ng/ml)'}], 'secondaryOutcomes': [{'measure': 'Buffer Capacity', 'timeFrame': '2 months', 'description': 'Buffer Capacity measured by PH meter'}, {'measure': 'Demographic, clinical and nutrition habits characteristics of participants Interview', 'timeFrame': '2 months', 'description': 'Demographic, clinical and nutrition habits characteristics of participants, using interview'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early childhood caries, salivary cystatin S protein, salivary buffer capacity'], 'conditions': ['Early Childhood Caries']}, 'descriptionModule': {'briefSummary': 'Aim of the study\n\n1. Measuring the levels of salivary cystatin S protein and salivary buffering capacity to determine their relation to early childhood caries.\n2. Predection of early childhood caries by using salivary cystatin S levels with demographic, clinical and nutrition habits characteristics of the participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '71 Months', 'minimumAge': '36 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'the patients going to diagnosis clinic of Pediatric dentistry and Dental Public Health Department, Cairo University', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically free children aged 36 to 71 months with one or more decayed (noncavitated or cavitated lesions), missing, or filled teeth due to caries in any primary tooth(cases).\n* Medically free children aged 36 to 71 months with no decayed, missing, or filled teeth due to caries in any primary tooth(controls).\n\nExclusion Criteria:\n\n* Children receiving antibiotic therapy within three month and fluoride prophylaxis within one year.\n* Parents who will refuse to participate or refuse to sign the informed consent.\n* Children who will not agree or cooperate with participation.'}, 'identificationModule': {'nctId': 'NCT05716867', 'briefTitle': 'Salivary Cystatin S Levels in a Group of Egyptian Children', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Evidence of Early Childhood Caries Prediction by Salivary Cystatin S Levels in a Group of Egyptian Children: a Case Control Study', 'orgStudyIdInfo': {'id': 'PEDO 1-2-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with early childhood caries aged between 36-71 month', 'interventionNames': ['Biological: Measurement of salivary cystatin S protein levels in saliva']}, {'label': 'Caries free children aged between 36-71 month', 'interventionNames': ['Biological: Measurement of salivary cystatin S protein levels in saliva']}], 'interventions': [{'name': 'Measurement of salivary cystatin S protein levels in saliva', 'type': 'BIOLOGICAL', 'description': 'The human cystatin S enzyme-linked immunosorbent assay (ELISA) kit will be used to measure the amounts of cystatin S in saliva for cases and controls', 'armGroupLabels': ['Caries free children aged between 36-71 month', 'Children with early childhood caries aged between 36-71 month']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Oral and Dental Medicine Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Tasneem Salah Sayed Mohamed Abo Ali', 'investigatorAffiliation': 'Cairo University'}}}}