Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 1:09 PM
Study NCT ID:
NCT00918060
Status:
UNKNOWN
Last Update Posted:
2010-10-13
First Post:
2009-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts as an Adjunct in Peridontitis Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2014-02-19', 'unreleaseDateUnknown': True}, {'resetDate': '2014-04-26', 'releaseDate': '2014-03-27'}], 'estimatedResultsFirstSubmitDate': '2014-02-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-09', 'studyFirstSubmitDate': '2009-06-10', 'studyFirstSubmitQcDate': '2009-06-10', 'lastUpdatePostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pocket depth reduction, clinical attachment level gain, gingival index, bleeding score', 'timeFrame': 'baseline, 1, 3 and 6 month after gel had loaded'}], 'secondaryOutcomes': [{'measure': 'plaque index', 'timeFrame': 'baseline, 1, 3, and 6 month after gel had loaded'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'referencesModule': {'references': [{'pmid': '25523604', 'type': 'DERIVED', 'citation': 'Rattanasuwan K, Rassameemasmaung S, Sangalungkarn V, Komoltri C. Clinical effect of locally delivered gel containing green tea extract as an adjunct to non-surgical periodontal treatment. Odontology. 2016 Jan;104(1):89-97. doi: 10.1007/s10266-014-0190-1. Epub 2014 Dec 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate clinical result including plaque index, gingival inflammation, bleeding score, pocket depth reduction and clinical attachment level gain after used locally-delivered gel containing Camella sinensis extracts as an adjunctive treatment in periodontal therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '34 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects have sound tooth with pocket depth = or \\> 5 mm. without caries, restoration, mobility and furcation involvement\n* no systemic complicated factors\n* no allergy to green tea or product of green tea\n* signing in informed consent form\n\nExclusion Criteria:\n\n* smoking\n* pregnancy or lactation\n* antibiotic premedication or antibiotic intake in previous 3 month'}, 'identificationModule': {'nctId': 'NCT00918060', 'briefTitle': 'Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts as an Adjunct in Peridontitis Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts', 'orgStudyIdInfo': {'id': 'COA. No. MU-IRB 2008/153.0511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'gel a', 'interventionNames': ['Drug: Camella sinensis gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'gel b', 'interventionNames': ['Drug: Camella sinensis gel']}], 'interventions': [{'name': 'Camella sinensis gel', 'type': 'DRUG', 'description': 'clinical effect of locally-delivered gel between Camella sinensis and placebo', 'armGroupLabels': ['gel a', 'gel b']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kanyawat Rattanasuwan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Oral Medicine, Mahidol University'}, {'name': 'Kanyawat Rattanasuwan', 'role': 'STUDY_CHAIR', 'affiliation': 'Maha Chakri Sirindhorn Dental Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kanyawat Rattanasuwan', 'oldOrganization': 'Department of Oral Medicine, Mahidol University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-02-19', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2014-03-27', 'type': 'RELEASE'}, {'date': '2014-04-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mahidol University'}}}}