Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-28 @ 1:57 PM
Study NCT ID:
NCT04369768
Status:
UNKNOWN
Last Update Posted:
2020-07-20
First Post:
2020-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094604', 'term': 'Molar Hypomineralization'}], 'ancestors': [{'id': 'D000094603', 'term': 'Dental Enamel Hypomineralization'}, {'id': 'D000094602', 'term': 'Developmental Defects of Enamel'}, {'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-17', 'studyFirstSubmitDate': '2020-04-28', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'treating hypersensitivity associated with MIH affected permanent molars by questioning the patient', 'timeFrame': 'one year', 'description': 'questioning the patient about hypersensitivity after performing treatment ( direct composite restorations and preformed metal crowns)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Molar Incisor Hypomineralization']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the clinical outcome of using direct esthetic composite restorations and the use of preformed metal crowns in managing MIH cases among a group of Egyptian children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with MIH in one fully erupted molar or more.\n* Age ranging from 7-12 years.\n* Cooperative children\n* Good general health.\n\nExclusion Criteria:\n\n* patients participating in other experiments.\n* Patients with parents planning to move away within the following year.\n* Patients with only mildly affected MIH molars that do not require extensive restorative treatment.\n* MIH-affected molars that have a very poor prognosis and require extraction.\n* First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta'}, 'identificationModule': {'nctId': 'NCT04369768', 'briefTitle': 'Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial (Part I)', 'orgStudyIdInfo': {'id': 'MIH restoration'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'direct composite restorations', 'interventionNames': ['Procedure: restoration of permanent molars affected with MIH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'preformed metal crowns', 'interventionNames': ['Procedure: restoration of permanent molars affected with MIH']}], 'interventions': [{'name': 'restoration of permanent molars affected with MIH', 'type': 'PROCEDURE', 'description': 'restore MIH affected molars using direct composite or preformed metal crowns', 'armGroupLabels': ['direct composite restorations', 'preformed metal crowns']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sandra Nasr Fares', 'role': 'CONTACT', 'email': 'dr.sandra.nasr@gmail.com', 'phone': '01225167030'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Sandra Nasr Fares', 'investigatorFullName': 'Sandra Nasr Fares', 'investigatorAffiliation': 'Cairo University'}}}}