Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT05102318
Status:
UNKNOWN
Last Update Posted:
2022-02-11
First Post:
2021-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Evaluation of Mineral Trioxide Aggregate and Biodentine as Pulp Medicaments in Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011672', 'term': 'Pulpotomy'}], 'ancestors': [{'id': 'D004708', 'term': 'Endodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-10-20', 'lastUpdatePostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.', 'timeFrame': '18 months', 'description': 'Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Direct pulp capping, Partial Pulpotomy, and Pulpotomy'], 'conditions': ['Pulp Disease, Dental']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.', 'detailedDescription': 'Screening of patients will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database in Pediatric Dentistry department.\n\nA total of 150 primary molars from healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain shams University.\n\nSubjects will be assigned randomly into two different treatment groups as follows:\n\nMTA Group (1):\n\n1. Group 1(A): MTA Direct Pulp Capping. (n=25)\n2. Group 1 (B): MTA Partial Pulpotomy. (n=25)\n3. Group 1 (C): MTA Complete Pulpotomy. (n=25)\n\nBiodentineTM Group (2):\n\n1. Group 2(A): BiodentineTM Direct Pulp Capping. (n=25)\n2. Group 2 (B): BiodentineTM Partial Pulpotomy. (n=25)\n3. Group 2 (C): BiodentineTM Complete Pulpotomy. (n=25)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinical symptoms or history implying irreversible pulpitis such as spontaneous pain, or pain persisting after stimuli removal.\n* Absence of periapical or interadicular radiolucencies, inflammatory root resorption, sinus tract or gingival abscess.\n\nExclusion Criteria:\n\n* Children who are extremely uncooperative and difficult to manage.\n* Children suffering from any physically or mentally disability that will complicate the treatment: Special Health Care needs (SHCN).\n* Teeth of poor prognosis due to presence of an abscess or a sinus, mobility, advanced bone or root resorption or Non-Restorable teeth.'}, 'identificationModule': {'nctId': 'NCT05102318', 'briefTitle': 'Clinical and Radiographic Evaluation of Mineral Trioxide Aggregate and Biodentine as Pulp Medicaments in Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'British University In Egypt'}, 'officialTitle': 'Clinical and Radiographic Evaluation of Mineral Trioxide Aggregate and Biodentine as Pulp Medicaments in Primary Molars', 'orgStudyIdInfo': {'id': 'Ain Shams University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Direct Pulp Capping with Biodentine', 'description': 'Direct Pulp Capping with Biodentine', 'interventionNames': ['Procedure: Direct Pulp Capping']}, {'type': 'EXPERIMENTAL', 'label': 'Partial Pulpotomy with Biodentine', 'description': 'Partial Pulpotomy with Biodentine', 'interventionNames': ['Procedure: Partial Pulpotomy']}, {'type': 'EXPERIMENTAL', 'label': 'Pulpotomy with Biodentine', 'description': 'Pulpotomy with Biodentine', 'interventionNames': ['Procedure: Pulpotomy']}, {'type': 'EXPERIMENTAL', 'label': 'Direct Pulp Capping with MTA', 'description': 'Direct Pulp Capping with MTA', 'interventionNames': ['Procedure: Direct Pulp Capping']}, {'type': 'EXPERIMENTAL', 'label': 'Partial Pulpotomy with MTA', 'description': 'Partial Pulpotomy with MTA', 'interventionNames': ['Procedure: Partial Pulpotomy']}, {'type': 'EXPERIMENTAL', 'label': 'Pulpotomy with MTA', 'description': 'Pulpotomy with MTA', 'interventionNames': ['Procedure: Pulpotomy']}], 'interventions': [{'name': 'Direct Pulp Capping', 'type': 'PROCEDURE', 'description': 'Direct Pulp Capping', 'armGroupLabels': ['Direct Pulp Capping with Biodentine', 'Direct Pulp Capping with MTA']}, {'name': 'Partial Pulpotomy', 'type': 'PROCEDURE', 'description': 'Partial Pulpotomy', 'armGroupLabels': ['Partial Pulpotomy with Biodentine', 'Partial Pulpotomy with MTA']}, {'name': 'Pulpotomy', 'type': 'PROCEDURE', 'description': 'Pulpotomy', 'armGroupLabels': ['Pulpotomy with Biodentine', 'Pulpotomy with MTA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Marwa Magdy, PhD', 'role': 'CONTACT', 'email': 'marwa.magdy@bue.edu.eg', 'phone': '00201007195996'}, {'name': 'Nadia Metwalli, Professor', 'role': 'CONTACT', 'email': 'nadia.metwalli@bue.edu.eg'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Marwa Magdy, PhD', 'role': 'CONTACT', 'email': 'marwa.magdy@bue.edu.eg', 'phone': '00201007195996'}, {'name': 'Nadia Metwalli, Professor', 'role': 'CONTACT', 'email': 'nadia.metwalli@bue.edu.eg'}], 'overallOfficials': [{'name': 'Noha Kabil, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'British University In Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British University In Egypt', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ain Shams University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Marwa Magdy', 'investigatorAffiliation': 'British University In Egypt'}}}}