Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-01-02 @ 1:54 PM
Study NCT ID:
NCT04137861
Status:
COMPLETED
Last Update Posted:
2021-02-25
First Post:
2019-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics (A Randomized Clinical Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2019-10-20', 'studyFirstSubmitQcDate': '2019-10-23', 'lastUpdatePostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical success', 'timeFrame': '9 months', 'description': 'Visual oral examination'}, {'measure': 'radiographic success', 'timeFrame': '9 months', 'description': 'Radiolucency assessment (+/-)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iatrogenic Perforation of Primary Molars']}, 'referencesModule': {'references': [{'pmid': '33483869', 'type': 'DERIVED', 'citation': 'Abdelmotelb MA, Gomaa YF, Khattab NMA, Elheeny AAH. Premixed bioceramics versus mineral trioxide aggregate in furcal perforation repair of primary molars: in vitro and in vivo study. Clin Oral Investig. 2021 Aug;25(8):4915-4925. doi: 10.1007/s00784-021-03800-3. Epub 2021 Jan 22.'}]}, 'descriptionModule': {'briefSummary': 'Furcal perforation is one of the most challenging procedural accidents during pulpotomy of primary molars and should be sealed as soon as possible to prevent bacterial invasion at perforation site and subsequent tooth extraction. The aim of the study is to compare bioceramics versus MTA as root repair material for treatment of furcal perforation in primary molars'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apparently healthy children aged from 4 to 7 years\n* No history of spontaneous pain or swelling\n* No signs or symptoms of irreversible pulpits or loss of vitality\n* Absence of radicular or priapical lesions.\n* Accidental furcal perforation should be immediate or mediate (within two weeks) perforation in primary molars.\n\nExclusion Criteria:\n\n* Children with systemic disease\n* Presence of priapical lesions'}, 'identificationModule': {'nctId': 'NCT04137861', 'briefTitle': 'Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics (A Randomized Clinical Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics', 'orgStudyIdInfo': {'id': '308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mineral Trioxide Aggregate (MTA)', 'description': 'Root repair material', 'interventionNames': ['Other: Bioceramics']}, {'type': 'EXPERIMENTAL', 'label': 'bioceramics', 'description': 'Root repair material', 'interventionNames': ['Other: Bioceramics']}], 'interventions': [{'name': 'Bioceramics', 'type': 'OTHER', 'description': 'root repair material', 'armGroupLabels': ['Mineral Trioxide Aggregate (MTA)', 'bioceramics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61111', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Minia University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmad Elheeny', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Ahmad Elheeny', 'investigatorAffiliation': 'Minia University'}}}}