Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT01197105
Status:
UNKNOWN
Last Update Posted:
2010-09-09
First Post:
2010-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-11-23', 'releaseDate': '2011-10-24'}, {'resetDate': '2012-09-24', 'releaseDate': '2012-08-24'}], 'estimatedResultsFirstSubmitDate': '2011-10-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2010-09-08', 'studyFirstSubmitDate': '2010-09-07', 'studyFirstSubmitQcDate': '2010-09-08', 'lastUpdatePostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival inflammation (Blood gingival index)', 'timeFrame': 'baseline', 'description': 'In this time frame will be assessed the initial gingival inflammation in children.'}, {'measure': 'Plaque amount', 'timeFrame': 'Baseline', 'description': 'In this time will be assessed the initial oral hygiene condition of the children before the use of the product through the Simplified Oral Hygiene Index.'}], 'secondaryOutcomes': [{'measure': 'Gingival inflammation (Blood gingival Index)', 'timeFrame': 'After 7 days (t1)', 'description': 'In this time frame will be assessed the gingival inflammation in children after 7 days using the product.'}, {'measure': 'Gingival inflammation (blood gingival index)', 'timeFrame': 'After 14 days (t2)', 'description': 'In this time frame will be assessed the final condition of the children after 14 days using the product.'}, {'measure': 'Plaque amount', 'timeFrame': 'After 7 days (t1)', 'description': 'In this time will be assessed the oral hygiene condition of the children after 7 days using the product (Through Simplified Oral Hygiene Index).'}, {'measure': 'Plaque amount', 'timeFrame': 'After 14 days (t2)', 'description': 'In this time will be assessed the final oral hygiene condition of the children after 14 days using the product (through the Simplified Oral Hygiene Index).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gingivitis', 'schinus terebinthifolius', 'natural products'], 'conditions': ['Gingivitis', 'Plaque Accumulation']}, 'referencesModule': {'references': [{'pmid': '14076341', 'type': 'BACKGROUND', 'citation': 'GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical efficacy of a mouthwash based on a natural product (Schinus terebinthifolius) used by children with gingivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age group: 10-12 years old\n* Presence of at least 20 dental elements\n* Do not use orthodontic fixed appliances\n* Simplified Oral Hygiene Index (S-OHI) is greater than 2\n* Levels of Microbiological Streptococcus mutans in saliva high (\\> 10,000 CFU / mL) (JENSEN; BRATTHALL, 1989)\n* Susceptibility to form biofilm and gingival inflammation\n* Absence of systemic disease\n* Not be under the use of antiseptic mouthwash in the last 3 months\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01197105', 'briefTitle': 'Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Paraíba'}, 'officialTitle': 'Clinical Evaluation of a Mouthwash Based on Schinus Terebinthifolius (Aroeira) Used by Children With Gingivitis', 'orgStudyIdInfo': {'id': 'ACTG 2612'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aroeira', 'interventionNames': ['Biological: Use of natural product (Schinus terebinthifolius)']}], 'interventions': [{'name': 'Use of natural product (Schinus terebinthifolius)', 'type': 'BIOLOGICAL', 'description': 'Mouthwash (0,3125% of schinus terebinthifolius) 10mL per day during 14 days.', 'armGroupLabels': ['Aroeira']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58.052-080', 'city': 'João Pessoa', 'state': 'Paraíba', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Maria José, Director', 'role': 'CONTACT', 'phone': '558332354184'}, {'name': 'Irlan de Almeida Freires, undergraduate dental student', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Francisco Campos Statal School', 'geoPoint': {'lat': -7.115, 'lon': -34.86306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Paraíba', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ricardo Dias de Castro', 'oldOrganization': 'Federal University of Paraiba'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-10-24', 'type': 'RELEASE'}, {'date': '2011-11-23', 'type': 'RESET'}, {'date': '2012-08-24', 'type': 'RELEASE'}, {'date': '2012-09-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Irlan de Almeida Freires, Dental Student, Federal University of Paraíba'}}}}