Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-28 @ 11:14 AM
Study NCT ID:
NCT05726357
Status:
UNKNOWN
Last Update Posted:
2023-08-03
First Post:
2023-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 380}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-02', 'studyFirstSubmitDate': '2023-02-01', 'studyFirstSubmitQcDate': '2023-02-11', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': 'day 3 post treatment', 'description': 'score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)'}], 'secondaryOutcomes': [{'measure': 'pain score', 'timeFrame': '6 months post treatment', 'description': 'score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vital pulp therapy'], 'conditions': ['Pulpitis - Irreversible']}, 'descriptionModule': {'briefSummary': 'high-quality evidence is needed to add to current knowledge and also assess the long-term outcomes for full/complete pulpotomy after carious pulpal exposure in patients with signs and symptoms indicative of irreversible pulpitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a mature permanent tooth\n* symptoms indicative of IRP\n* responsive to cold and EPT sensibility testing\n* restorable and can be adequately isolated during treatment\n* One tooth (molar or premolar) per patient.\n\nExclusion Criteria:\n\n* active periodontal disease\n* complex medical histories\n* unable to consent\n* pregnant or breast-feeding\n* excessive bleeding that cannot be controlled'}, 'identificationModule': {'nctId': 'NCT05726357', 'briefTitle': 'Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis', 'organization': {'class': 'OTHER', 'fullName': 'British University In Egypt'}, 'officialTitle': 'Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis: A Randomised Control Trial', 'orgStudyIdInfo': {'id': 'FD BUE REC 22-034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard root canal treatment', 'description': 'standard root canal treatment', 'interventionNames': ['Procedure: vital pulp therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pulpotomy', 'description': 'vital pulp therapy', 'interventionNames': ['Procedure: vital pulp therapy']}], 'interventions': [{'name': 'vital pulp therapy', 'type': 'PROCEDURE', 'description': 'removal of the coronal pulp followed by placing a biocompatible material to preserve the vitality of the radicular pulp', 'armGroupLabels': ['Pulpotomy', 'standard root canal treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11837', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'shehabeldin mohamed saber, phd', 'role': 'CONTACT', 'email': 'shehabeldin.saber@bue.edu.eg', 'phone': '+201001413734'}, {'name': 'dalia ghalwash, phd', 'role': 'CONTACT', 'email': 'dalia.ghalwash@bue.edu.eg', 'phone': '+201005120159'}], 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Shehabeldin Saber, phD', 'role': 'CONTACT', 'email': 'shehabeldin.saber@bue.edu.eg', 'phone': '+202 26890000', 'phoneExt': '1065'}, {'name': 'Dalia Ghalwash, phD', 'role': 'CONTACT', 'email': 'dalia.ghalwash@bue.edu.eg', 'phone': '+202 26890000', 'phoneExt': '1066'}], 'overallOfficials': [{'name': 'shehabeldin Saber', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Endodontics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'not to be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British University In Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'shehabeldin saber', 'investigatorAffiliation': 'British University In Egypt'}}}}