Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-03 @ 3:10 PM
Study NCT ID:
NCT02291120
Status:
UNKNOWN
Last Update Posted:
2014-11-14
First Post:
2014-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MEDCEM PC and MTA in Pulpotomies of Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011672', 'term': 'Pulpotomy'}], 'ancestors': [{'id': 'D004708', 'term': 'Endodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-11', 'studyFirstSubmitDate': '2014-06-27', 'studyFirstSubmitQcDate': '2014-11-11', 'lastUpdatePostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success', 'timeFrame': '24 months', 'description': 'No pain, no swelling, no fistula or sinus tract, no pathologic mobility'}, {'measure': 'Radiographic success', 'timeFrame': '24 months', 'description': 'No internal root resorption progressing into the bone, no external root resorption, no furcation and/or periapical bone destruction'}]}, 'conditionsModule': {'conditions': ['Evaluate the Effects of MEDCEM PC and MTA in Pulpotomies of Primary Molars.']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate and compare, clinically and radiographically,the effects of MEDCEM PC and MTA when used as pulp dressings following pulpotomy in human primary molars.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy children\n* molars showing: symptomless exposure of vital pulp by caries no clinical or radiographic evidence of pulp degeneration (excessive bleeding from the root canal, internal root resorption, inter-radicular and/or furcal bone destruction) the possibility of proper restoration of the teeth no physiological resorption of more than one-third of the root\n\nExclusion Criteria:\n\n* presence of systemic pathology\n* history of allergic reaction to latex, local anaesthetics or to the constituents of the test pulp dressing agents'}, 'identificationModule': {'nctId': 'NCT02291120', 'briefTitle': 'MEDCEM PC and MTA in Pulpotomies of Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Internacional de Catalunya'}, 'orgStudyIdInfo': {'id': 'UIC-ODP-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MTA', 'description': 'ProRoot® MTA is a root canal repair material that is a unique improvement over other materials used for root canal repair. Made up of fine hydrophilic particles that set in the presence of water, ProRoot® MTA seals off all pathways between the root canal system and surrounding tissues, significantly reducing bacterial migration. Its excellent compatibility with the dentinal wall allows for a predictable clinical healing response.', 'interventionNames': ['Procedure: Pulpotomy']}, {'type': 'EXPERIMENTAL', 'label': 'MedCem Portland Cement (PC)', 'description': 'MedCem PC is an excellent capping material for cariology on permanent teeth (direct and indirect capping) and in milk tooth endodontics (milk tooth amputation). Is characterized by excellent colour stability and neutrality and does not contain any additional ingredients', 'interventionNames': ['Procedure: Pulpotomy']}], 'interventions': [{'name': 'Pulpotomy', 'type': 'PROCEDURE', 'armGroupLabels': ['MTA', 'MedCem Portland Cement (PC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08195', 'city': 'Sant Cugat del Vallès', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Cristina Cuadros Fernandez, DDS, MsC', 'role': 'CONTACT', 'email': 'cuadros@uic.es', 'phone': '0034 93 5045000'}], 'facility': 'Universitat Internacional de Catalunya', 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Internacional de Catalunya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's Program Director in Pediatric Dentistry", 'investigatorFullName': 'Cristina Cuadros', 'investigatorAffiliation': 'Universitat Internacional de Catalunya'}}}}