Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-02-26 @ 1:06 AM
Study NCT ID:
NCT00554034
Status:
COMPLETED
Last Update Posted:
2010-12-21
First Post:
2007-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Herbal Extracts on Gingival Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-19', 'studyFirstSubmitDate': '2007-10-15', 'studyFirstSubmitQcDate': '2007-11-05', 'lastUpdatePostDateStruct': {'date': '2010-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the correct dosing of the herbal Patch [THPP]', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'To demonstarte the safety of THPP on the gingival tissue and in the oral cavity', 'timeFrame': '3 months'}]}, 'conditionsModule': {'keywords': ['gingivitis, localized treatment'], 'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the minimal number of patches needed to get an effective response. Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study. After the first 20 patients \\[5 cycles\\], the effect of the number of patches will be tested. If there is no distinct reduction of beta glucuronidase in the GCF or of gingival index at the tested sites, more patients will be enrolled. Patients will be added one cycle at a time with results being tested and analyzed. The enrollemnts of patients will stop when a dose response will be noticed or 15 cycles have been reached.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 -75.\n2. Severe localized gingival inflammation \\[GI index 2 or greater\n\nExclusion Criteria:\n\n1. Pregnancy or a wish to become pregnant during the study.\n2. History of periodontal treatment within the last month.\n3. Antibiotic treatment within the last month\n4. Use of any antimicrobial mouthrinse within the last month.\n5. Participation in another trial one month prior to the study.\n6. Inability to behave compliant to the trial protocol by not placing all the patches given, or attending scheduled appointments.\n7. Systemic Disease.\n8. Patients using salicylate'}, 'identificationModule': {'nctId': 'NCT00554034', 'briefTitle': 'Effect of Herbal Extracts on Gingival Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'The Effect of Herbal Extracts on Inflammatory Enzymes in the Gingiva: a Dose Finding Study.', 'orgStudyIdInfo': {'id': 'Protocol C-4'}}, 'armsInterventionsModule': {'interventions': [{'name': 'periopatch', 'type': 'DRUG', 'description': 'Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Jerusalem Perio Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Menachem Oberbaum, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaare Zedek Medical Center, Jerusalem, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Menachem Oberbaum, MD', 'oldOrganization': 'Shaare Zedek Medical Center'}}}}