Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 9:02 PM
Study NCT ID:
NCT01010451
Status:
COMPLETED
Last Update Posted:
2009-11-10
First Post:
2009-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antimicrobial Pulpotomy of Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009336', 'term': 'Necrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-09', 'studyFirstSubmitDate': '2009-11-06', 'studyFirstSubmitQcDate': '2009-11-09', 'lastUpdatePostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pulpotomy', 'pulpectomy', 'primary teeth', 'dental care for children'], 'conditions': ['Inflammation', 'Necrosis']}, 'descriptionModule': {'briefSummary': 'There is a lack of evidence of the long-term successful outcomes of antimicrobial endodontic treatment for primary teeth. This study intended to evaluate (by survival analysis) the effectiveness of an antimicrobial pulpotomy (chloramphenicol, tetracycline, zinc oxide/eugenol) in primary molars compared to calcium hydroxide pulpectomy, testing the hypothesis that antimicrobial pulpotomy could be an alternative pulp therapy for primary teeth with pulp inflammation or necrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy children (ASA PS 1)\n* Children presenting one or more primary molar with pulp inflammation or necrosis due to carious lesion and indicated for endodontic therapy\n\nExclusion Criteria:\n\n* Lost to follow-up'}, 'identificationModule': {'nctId': 'NCT01010451', 'briefTitle': 'Antimicrobial Pulpotomy of Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Goias'}, 'officialTitle': 'Survival of Primary Molars Treated With Antimicrobial Pulpotomy or Calcium Hydroxide Pulpectomy', 'orgStudyIdInfo': {'id': '3222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antimicrobial pulpotomy', 'description': 'Pulpotomy of primary molars with pulp inflammation or necrosis due to carious lesions using an antimicrobial paste', 'interventionNames': ['Procedure: Antimicrobial pulpotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Calcium hydroxide pulpectomy', 'description': 'Pulpectomy of primary molars with pulp inflammation or necrosis due to carious lesions using a calcium hydroxide paste as intracanal medication', 'interventionNames': ['Procedure: Calcium hydroxide pulpectomy']}], 'interventions': [{'name': 'Antimicrobial pulpotomy', 'type': 'PROCEDURE', 'otherNames': ['Antibacterial pulp therapy', 'Antibacterial pulpotomy', 'Non-vital pulpotomy'], 'description': 'Pulpotomy of inflamed or necrotic pulp using an antimicrobial paste (chloramphenicol, tetracycline, zinc oxide/eugenol)as medication.', 'armGroupLabels': ['Antimicrobial pulpotomy']}, {'name': 'Calcium hydroxide pulpectomy', 'type': 'PROCEDURE', 'description': 'Pulpectomy of inflamed or necrotic pulp using a calcium hydroxide paste as medication', 'armGroupLabels': ['Calcium hydroxide pulpectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74605220', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Dental School', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Goias', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Universidade Federal de Goias', 'oldOrganization': 'Dental School'}}}}