Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-03-01 @ 4:46 PM
Study NCT ID:
NCT01811420
Status:
COMPLETED
Last Update Posted:
2013-03-14
First Post:
2013-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemomechanical Caries Removal Using Papain Gel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-12', 'studyFirstSubmitDate': '2013-03-06', 'studyFirstSubmitQcDate': '2013-03-12', 'lastUpdatePostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'radiographic status', 'timeFrame': '18 months', 'description': 'the restauration will be assessed by radiographic examination for detection the current caries'}], 'primaryOutcomes': [{'measure': 'restauration evaluation', 'timeFrame': '18 months', 'description': 'the restauration will be assessed by clinical examination for detection the current caries'}], 'secondaryOutcomes': [{'measure': 'discomfort or pain', 'timeFrame': '6 months', 'description': 'The Faces Pain Scale was used to evaluate the need for local anesthesia during the procedure. The child was asked to choose a face matching the intensity of his or her pain experience during the procedure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dental caries', 'caries removal', 'chemomechanical caries removal'], 'conditions': ['Dental Caries']}, 'referencesModule': {'references': [{'pmid': '24838896', 'type': 'DERIVED', 'citation': 'Motta LJ, Bussadori SK, Campanelli AP, Silva AL, Alfaya TA, Godoy CH, Navarro MF. Efficacy of Papacarie((R)) in reduction of residual bacteria in deciduous teeth: a randomized, controlled clinical trial. Clinics (Sao Paulo). 2014;69(5):319-22. doi: 10.6061/clinics/2014(05)04.'}, {'pmid': '24363672', 'type': 'DERIVED', 'citation': 'Motta LJ, Bussadori SK, Campanelli AP, da Silva AL, Alfaya TA, de Godoy CH, Navarro MF. Pain during Removal of Carious Lesions in Children: A Randomized Controlled Clinical Trial. Int J Dent. 2013;2013:896381. doi: 10.1155/2013/896381. Epub 2013 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of a papain-based gel in caries removal.', 'detailedDescription': 'Twenty children with at least two carious molar teeth without pulpal involvement participated in this randomized clinical trial. A total of 40 teeth were randomly divided into two treatment groups: group A, papain-based gel; and group B, conventional technique. Data collection included the time required for caries removal, need for local anesthesia, degree of discomfort, changes in the number of viable bacteria, and clinical evaluation of glass ionomer-cement restorations 6-month post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with active caries without pulpal involvement in two deciduous molar teeth participated in the trial.\n* The caries were located on the occlusal surface.\n\nExclusion Criteria:\n\n* Children with pathological process of the dental tissue, with pulpal involvement'}, 'identificationModule': {'nctId': 'NCT01811420', 'acronym': 'CMCR09', 'briefTitle': 'Chemomechanical Caries Removal Using Papain Gel', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'Chemomechanical Caries Removal Using a Papain-Based Gel: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'cariesremoval09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHEMOMECHANICAL CARIES REMOVAL', 'description': 'Dental caries removal using papain based gel', 'interventionNames': ['Procedure: Chemomechanical Caries Removal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional method', 'description': 'Dental caries removal using rotatory instrument', 'interventionNames': ['Procedure: Conventional method']}], 'interventions': [{'name': 'Chemomechanical Caries Removal', 'type': 'PROCEDURE', 'description': 'Chemomechanical Caries Removal Using A Papain-Based Gel', 'armGroupLabels': ['CHEMOMECHANICAL CARIES REMOVAL']}, {'name': 'Conventional method', 'type': 'PROCEDURE', 'description': 'Dental caries removal using rotatory instrument', 'armGroupLabels': ['conventional method']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01156-080', 'city': 'São Paulo', 'state': 'Sao Apaulo', 'country': 'Brazil', 'facility': 'Universidade Nove de Julho', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Lara J Motta, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nove de Julho'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nove de Julho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Professor', 'investigatorFullName': 'Lara Jansiski Motta', 'investigatorAffiliation': 'University of Nove de Julho'}}}}