Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:23 AM
Study NCT ID:
NCT07355920
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-23
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Alkasite for Postpulpotomy Restoration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-21', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical evaluation of the final restoration according to USPHS Criteria', 'timeFrame': 'at 3, 6, and 9 months', 'description': 'Clinical evaluation of the final restoration is done according to the modified united states public health service USPHS Criteria for direct clinical evaluation of restoration'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cention forte', 'tetric n ceram', 'alkasite'], 'conditions': ['Pediatric Dentistry', 'Post Pulpotomy Restoration']}, 'referencesModule': {'references': [{'pmid': '36832414', 'type': 'BACKGROUND', 'citation': 'Kaur K, Suneja B, Jodhka S, Saini RS, Chaturvedi S, Bavabeedu SS, Alhamoudi FH, Cicciu M, Minervini G. Comparison between Restorative Materials for Pulpotomised Deciduous Molars: A Randomized Clinical Study. Children (Basel). 2023 Feb 1;10(2):284. doi: 10.3390/children10020284.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study will be directed to:\n\nEvaluate the clinical performance of alkasite composite as a final restoration for pulpotomized primary molars.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Deep carious vital primary molars at site 1, 2, and size 3 according to the SI/STA classification of caries.\n* Healthy children free from systemic diseases.\n* Cooperative patient: Frankel rating 3,4.\n\nRadiographically:\n\n* Deep caries approximating the pulp.\n* Roots with no more than one-third physiologic resorption.\n* Normal lamina dura and periodontal ligament space.\n\nExclusion Criteria:\n\n* Patients with bruxism.\n* Clinical signs or symptoms of irreversible pulpitis or pulp degeneration.\n* Parents refuse treatment.\n\nRadiographically:\n\n* Furcation involvement.\n* periapical lesion.\n* Pathologic resorption (internal or external).'}, 'identificationModule': {'nctId': 'NCT07355920', 'acronym': 'Cention-Forte', 'briefTitle': 'Use of Alkasite for Postpulpotomy Restoration', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Clinical Evaluation of Alkasite Composite as a Final Restoration for Pulpotomized Primary Molars.', 'orgStudyIdInfo': {'id': '#P-PED-6-24-2204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I: Study group :Alkasite( cention forte )', 'description': '25 primary molars were restored with an Alkasite composite Cention-forte after Formocresol pulpotomy.', 'interventionNames': ['Procedure: Cention Forte']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II :Control group: Tetric N-Ceram', 'description': '25 primary molars were restored with Tetric® N-Ceram bulk-fill composite after Formocresol pulpotomy.', 'interventionNames': ['Procedure: Tetric® N-Ceram']}], 'interventions': [{'name': 'Cention Forte', 'type': 'PROCEDURE', 'otherNames': ['alkasite'], 'description': '25 primary molars were restored with an Alkasite composite Cention-forte after Formocresol pulpotomy.', 'armGroupLabels': ['Group I: Study group :Alkasite( cention forte )']}, {'name': 'Tetric® N-Ceram', 'type': 'PROCEDURE', 'otherNames': ['bulk-fill composite'], 'description': '5 primary molars were restored with Tetric® N-Ceram bulk-fill composite after Formocresol pulpotomy.', 'armGroupLabels': ['Group II :Control group: Tetric N-Ceram']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'The clinical study was carried out at the clinic of Pediatric and Preventive Dentistry Department, Faculty of dentistry, Tanta university.', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Faten Abu Taleb', 'role': 'STUDY_CHAIR', 'affiliation': 'faculty of dentistry Tanta university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Manar Taha Mokhtar Hamed Elsayed', 'investigatorAffiliation': 'Tanta University'}}}}