Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-01-12 @ 6:11 PM
Study NCT ID:
NCT00978861
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
2009-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006861', 'term': 'Hydrogen Peroxide'}], 'ancestors': [{'id': 'D010545', 'term': 'Peroxides'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-16', 'studyFirstSubmitDate': '2009-08-31', 'studyFirstSubmitQcDate': '2009-09-16', 'lastUpdatePostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'colorimeter', 'timeFrame': '12 weeks after treatment'}], 'secondaryOutcomes': [{'measure': 'colorimeter', 'timeFrame': '24 weeks after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Tooth Whitening']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of REMEWHITE on tooth whitening.', 'detailedDescription': 'This study intended to establish the efficacy of REMEWHITE after using the product under controlled conditions at the hospital.\n\nThe efficacy of the product was assessed at the end of the study; clinical examination by the dentist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ability to understand and provide informed consent\n* general good health male and female adults, were 20 years or older\n* no pregnant woman\n* had six caines-free maxillary anterior teeth without restorations on the labial surfaces\n\nExclusion Criteria:\n\n* had severe internal discoloration (tetracycline stains, fluorosis, pulpless teeth)\n* evidence of fracture or major cracks on tooth\n* were pregnant or nursing\n* had tooth sensitivity\n* smokers\n* had teeth shade A1, A2'}, 'identificationModule': {'nctId': 'NCT00978861', 'acronym': 'REMEWHITE', 'briefTitle': 'Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE', 'organization': {'class': 'INDUSTRY', 'fullName': 'JDC Tech'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE', 'orgStudyIdInfo': {'id': 'RE5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'whitening', 'description': '30% Hydrogen peroxide', 'interventionNames': ['Drug: Hydrogen Peroxide']}], 'interventions': [{'name': 'Hydrogen Peroxide', 'type': 'DRUG', 'description': 'Whitening product syringe type', 'armGroupLabels': ['whitening']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': "The cathiloc university of korea seoul st. mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Je-Uk Park, PI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The cathiloc university of korea seoul st. mary's hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JDC Tech', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Je-Uk park / PI', 'oldOrganization': "The catholic university of korea seoul st. mary's hospital"}}}}