Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT04485520
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2020-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2017-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2020-07-21', 'studyFirstSubmitQcDate': '2020-07-23', 'lastUpdatePostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Colony Forming units (Stage 1)', 'timeFrame': 'thorough study completion, an average of 24 hours', 'description': 'Before Intervention'}, {'measure': 'Number of Colony Forming units (Stage 2)', 'timeFrame': '10 minutes after mouthwash use', 'description': 'After Intervention'}, {'measure': 'Number of Colony Forming units (Stage 3)', 'timeFrame': '8 days after mouthwash use', 'description': 'After Intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Saliva', 'dental plaque', 'streptococcus mutans'], 'conditions': ['Streptococcus, Other Specified Group', 'Dental Plaque']}, 'referencesModule': {'references': [{'pmid': '30486374', 'type': 'BACKGROUND', 'citation': 'Saliasi I, Llodra JC, Bravo M, Tramini P, Dussart C, Viennot S, Carrouel F. Effect of a Toothpaste/Mouthwash Containing Carica papaya Leaf Extract on Interdental Gingival Bleeding: A Randomized Controlled Trial. Int J Environ Res Public Health. 2018 Nov 27;15(12):2660. doi: 10.3390/ijerph15122660.'}]}, 'descriptionModule': {'briefSummary': 'Papaya has effects on oral pathogenic microorganisms, it also has anticoagulant quality, amebicidal action, antimicrobial, bacteriostatic and antifungal activity on different bacteria, especially on Streptococcus mutans, this can be exploited in the dental area. The objective of the study was to determine the efficacy of Carica Papaya peel extract (suckling) as an inhibitor of Streptococcus Mutans in students of the dental faculty of the National University of Caaguazú in 2018.', 'detailedDescription': 'Specific objectives\n\n* To determine the inhibition of the extract of the peel of Carica Papaya (baby) at 3% on Streptococcus Mutans by age and sex grouping.\n* To quantify the inhibition of the extract of the peel of Carica Papaya (baby) at 3% on the growth of Streptococcus Mutans before, at 10 minutes and 8 days of use in the experimental group.\n* Quantify the inhibition of 0.12% Chlorhexidine Gluconate on the growth of Streptococcus Mutans before, after 10 minutes and 8 days of use in the control group.\n* Compare the count of Colony Forming Units (CFU) between both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants that signed the informed consent\n\nExclusion Criteria:\n\n* allergic to carica papaya\n* ongoing medical or dental treatment that could interfere with the results.'}, 'identificationModule': {'nctId': 'NCT04485520', 'briefTitle': 'Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Nacional de Caaguazu'}, 'officialTitle': 'Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans in Students of the Faculty of Dentistry in the Year 2018', 'orgStudyIdInfo': {'id': '00140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carica Papaya extract', 'description': 'Carica Papaya at 3%', 'interventionNames': ['Other: CARICA PAPAYA MOUTHWASH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine', 'description': '0.12% chlorhexidine mouthwash formulation (commercially available)', 'interventionNames': ['Other: CHLORHEXIDINE MOUTHWASH']}], 'interventions': [{'name': 'CARICA PAPAYA MOUTHWASH', 'type': 'OTHER', 'description': 'Each application was 10 ml. applied for 1 minute, once a day for 8 days', 'armGroupLabels': ['Carica Papaya extract']}, {'name': 'CHLORHEXIDINE MOUTHWASH', 'type': 'OTHER', 'description': 'Each application was 10 ml. applied for 1 minute, once a day for 8 days', 'armGroupLabels': ['Chlorhexidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '595', 'city': 'Coronel Oviedo', 'state': 'International', 'country': 'Paraguay', 'facility': 'Facultad de Odontología Universidad Nacional de Caaguazú', 'geoPoint': {'lat': -25.44613, 'lon': -56.43928}}], 'overallOfficials': [{'name': 'Diego Céspedes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Facultad de Odontología, Universidad Nacional de Caaguazu'}, {'name': 'Ulises A Villasanti Torales', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Facultad de Odontologia, Universidad Nacional de Caaguazu'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'From the time the protocol is available in clinical trials.gov and with no limit of time', 'ipdSharing': 'YES', 'description': 'By email', 'accessCriteria': 'Researchers that want to know about the study and use the protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Julieta María Méndez Romero', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Writting and Publication Department, Regional Health Research Institute', 'investigatorFullName': 'Julieta María Méndez Romero', 'investigatorAffiliation': 'Universidad Nacional de Caaguazu'}}}}