Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-28 @ 12:07 AM
Study NCT ID:
NCT04973761
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2021-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life for Children With Zirconium Anteroir Crowns Versus Strip Composite Crowns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-02', 'studyFirstSubmitDate': '2021-07-17', 'studyFirstSubmitQcDate': '2021-07-21', 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral health related quality of life', 'timeFrame': '12 months', 'description': 'Early Childhood Oral Health Impact Scale (ECOHIS).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caries']}, 'descriptionModule': {'briefSummary': 'Early Childhood Oral Health Impact Scale (ECOHIS) will be used for detection of oral health related quality of life for children using strip composite crowns versus zirconium crowns at 6 and 12 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy children Cariuos primary anteroir teeth Cooperative children\n\nExclusion Criteria:\n\n* children with systemic diseases Children with bad oral habits'}, 'identificationModule': {'nctId': 'NCT04973761', 'briefTitle': 'Quality of Life for Children With Zirconium Anteroir Crowns Versus Strip Composite Crowns', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Evaliation of Oral Health Quality of Life for Children With Zirconium Crowns Versus Anteroir Strip Composite Crowns After 6 and 12 Months', 'orgStudyIdInfo': {'id': '401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Strip composite crowns', 'interventionNames': ['Other: Strip composite crowns']}, {'type': 'EXPERIMENTAL', 'label': 'Zirconium crowns', 'interventionNames': ['Other: Zirconium crowns']}], 'interventions': [{'name': 'Zirconium crowns', 'type': 'OTHER', 'description': 'Prefabricated pirmary anteroir teeth zirconium crowns', 'armGroupLabels': ['Zirconium crowns']}, {'name': 'Strip composite crowns', 'type': 'OTHER', 'description': 'Strip composite crowns', 'armGroupLabels': ['Strip composite crowns']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61111', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Minia University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Mahmoud Ahmed Mahmoud', 'investigatorAffiliation': 'Minia University'}}}}