Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT02175368
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2014-06-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adhese One F Upgrade in Direct Filling Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'erik.braziulis@ivoclarvivadent.com', 'title': 'Dr. Erik Braziulis', 'organization': 'Ivoclar Vivadent AG'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Adhese One F Upgrade', 'description': 'Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).\n\nAdhese One F Upgrade', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adhese One F Upgrade', 'description': 'Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).\n\nAdhese One F Upgrade'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 week', 'description': 'Clinical success is defined as no postoperative hypersensitivity and no loss of the restoration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adhese One F Upgrade', 'description': 'Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).\n\nAdhese One F Upgrade'}], 'classes': [{'categories': [{'title': 'Patients with satisfactory clinical outcome', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Patients with unsatisfactory clinical outcome', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'The clinical quality of the restorations will be evaluated according to semi-quantitative clinical evaluation (SQUACE) criteria and compared at all time points and at the end of the study.\n\nSQUACE is a published semi-quantitative method to evaluate the clinical success of dental restorations that is based on the commonly used USPHS criteria. The quality of the restoration is rated according to the SQUACE scale and classified as acceptable (patients with satisfactory clinical outcome) or not acceptable (patients with unsatisfactory clinical outcome).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adhese One F Upgrade', 'description': 'Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).\n\nAdhese One F Upgrade'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Adhese One F Upgrade', 'description': 'Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).\n\nAdhese One F Upgrade'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Liechtenstein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2015-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2014-06-20', 'resultsFirstSubmitDate': '2018-03-12', 'studyFirstSubmitQcDate': '2014-06-25', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-12', 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinical Success', 'timeFrame': '1 week', 'description': 'Clinical success is defined as no postoperative hypersensitivity and no loss of the restoration.'}], 'secondaryOutcomes': [{'measure': 'Clinical Quality', 'timeFrame': '3 years', 'description': 'The clinical quality of the restorations will be evaluated according to semi-quantitative clinical evaluation (SQUACE) criteria and compared at all time points and at the end of the study.\n\nSQUACE is a published semi-quantitative method to evaluate the clinical success of dental restorations that is based on the commonly used USPHS criteria. The quality of the restoration is rated according to the SQUACE scale and classified as acceptable (patients with satisfactory clinical outcome) or not acceptable (patients with unsatisfactory clinical outcome).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['total etch protocol', 'direct filling therapy'], 'conditions': ['Dental Adhesive']}, 'descriptionModule': {'briefSummary': 'Investigation on the clinical performance of a new dental adhesive when used in direct filling therapy after phosphoric acid etching.\n\nHypothesis: The new adhesive shows an acceptable clinical performance and allows a good filling quality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* indication for class I or II filling\n* max. 2 restorations per patient\n* vital teeth\n* sufficient language skills\n\nExclusion Criteria:\n\n* dry working field cannot be established\n* if the patient is known to be allergic to any of the materials' ingredients\n* severe systemic diseases\n* pregnancy\n* non-vital or pulpitic teeth\n* indication for indirect restoration"}, 'identificationModule': {'nctId': 'NCT02175368', 'briefTitle': 'Adhese One F Upgrade in Direct Filling Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ivoclar Vivadent AG'}, 'officialTitle': 'Clinical Evaluation of AdheSE One F Upgrade in Direct Filling Therapy', 'orgStudyIdInfo': {'id': 'AOFU 2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adhese One F Upgrade', 'description': 'Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol).', 'interventionNames': ['Device: Adhese One F Upgrade']}], 'interventions': [{'name': 'Adhese One F Upgrade', 'type': 'DEVICE', 'armGroupLabels': ['Adhese One F Upgrade']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Arnd Peschke, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ivoclar Vivadent AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ivoclar Vivadent AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}