Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-28 @ 6:51 PM
Study NCT ID:
NCT00802256
Status:
UNKNOWN
Last Update Posted:
2009-04-10
First Post:
2008-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of Pulpotomized Primary Molars With Mineral Trioxide Aggregate and New Endodonthic Cement
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-04-09', 'studyFirstSubmitDate': '2008-12-03', 'studyFirstSubmitQcDate': '2008-12-03', 'lastUpdatePostDateStruct': {'date': '2009-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical features and radiographic examination', 'timeFrame': '6 monthes and one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pulpotomy', 'primary molar teeth', 'MTA', 'NEC', 'CEM', 'Primary Molar Teeth Which Require Pulpotomy Treatment'], 'conditions': ['Pulpotomy Treatment']}, 'descriptionModule': {'briefSummary': 'A new Endodontic Cement (NEC) is being compared with mineral trioxide aggregate in pulpotomy of primary molars.', 'detailedDescription': 'Forty patient are selected randomly. Each patient has at least 2 teeth which require pulpotomy treatment. After removing of carious teeth by a low speed round bur and pulp exposure, roof of pulp chamber is removed completely by a high speed 008 fissure bur. Life tissues of pulp are removed by sharp excavator and rinsing with normal salin. Hemostat is achieved and cavity will be cleaned by 0.5% hypo chlorate solution. MTA or NEC material is mixed according to manufacturer instruction and will be placed in pulp chamber and over pulpal canal orifices for at least 1 mm. The light cure glass inomor is also mixed according to manufacturer instruction and is places over the A or B material and cured for 40 minutes. The treated tooth will be restored with a stainless steel crown or amalgam filling material.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vital pulp exposure of teeth with caries or trauma\n* No clinical signs \\& symptoms like pain,inflammation\n* No radiographic signs \\& symptoms like: internal resorption,external resorption, furcation involvement,pulp canal obliteration.\n* The restorable tooth\n* No dental treatment contraindication\n\nExclusion Criteria:\n\n* Systemic diseases\n* Existence of pain,inflammation or sinus tract\n* No patient compliance'}, 'identificationModule': {'nctId': 'NCT00802256', 'briefTitle': 'Comparative Evaluation of Pulpotomized Primary Molars With Mineral Trioxide Aggregate and New Endodonthic Cement', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Comparative Evaluation of Pulpotomized Primary Molars With Mineralized Trioxide Aggregate & New Endodonthic Cement', 'orgStudyIdInfo': {'id': '63sh138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'teeth which are treated with Mineral Trioxide Aggregate (MTA) material', 'interventionNames': ['Procedure: pulpotomy']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'teeth which are treated with new Endodontic Cement (NEC) material', 'interventionNames': ['Procedure: pulpotomy']}], 'interventions': [{'name': 'pulpotomy', 'type': 'PROCEDURE', 'description': 'removal of caries and cronal pulp tissue and then restoring of tooth', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Fatemeh Shekarchi, student', 'role': 'CONTACT', 'email': 'fshekarchi84@yahoo.com', 'phone': '00989124849179'}, {'name': 'Dr. Saeed Asgary, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dr. Beheshteh Malekafzali, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fatemeh Shekarchi, student', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dr. Mahdiyeh Beheshti, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Saheed Behesti University for Medical sciences', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Fatemeh Shekarchi, student', 'role': 'CONTACT', 'email': 'fshekarchi84@yahoo.com', 'phone': '00989124849179'}], 'overallOfficials': [{'name': 'Fatemeh Shekarchi, student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saheed Behesti University for Medical sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Iranian center for endodontic research', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Fatemeh Shekarchi', 'oldOrganization': 'Shaheed Beheshti University of Medical Sciences'}}}}