Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-27 @ 2:19 AM
Study NCT ID:
NCT01411592
Status:
UNKNOWN
Last Update Posted:
2014-09-11
First Post:
2011-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C502351', 'term': 'multilink adhesive system'}, {'id': 'D008670', 'term': 'Metals'}], 'ancestors': [{'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sekretariat@proth.uni-kiel.de', 'phone': '+494315972874', 'title': 'Dr. Martin Sasse, D.M.D., Assistant Professor', 'organization': 'University of Kiel'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Multilink', 'description': '14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system \\[A/B primer and Multilink-Automix\\] with Metal/Zirconia primer).\n\nMultilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).\n\nPatients were recalled after 6 and 12 months, and then annually.', 'otherNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Panavia 21 TC', 'description': '16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.\n\nPanavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.\n\nPatients were recalled after 6 and 12 months, and then annually.', 'otherNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Debonding', 'notes': 'Debonding of RBFDP. Treatment: Rebonding as initially conducted.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': '[Small Caries lesion]', 'notes': 'Treatment: Composite resin filling.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': '[Rotation of abutment tooth]', 'notes': 'Treatment: Derotated with a splint.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Final Loss of the Restauration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multilink', 'description': '14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system \\[A/B primer and Multilink-Automix\\] with Metal/Zirconia primer).\n\nMultilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).\n\nPatients were recalled after 6 and 12 months, and then annually.'}, {'id': 'OG001', 'title': 'Panavia 21 TC', 'description': '16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.\n\nPanavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.\n\nPatients were recalled after 6 and 12 months, and then annually.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Debonding of the RBFDP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multilink', 'description': '14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system \\[A/B primer and Multilink-Automix\\] with Metal/Zirconia primer).\n\nMultilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).\n\nPatients were recalled after 6 and 12 months, and then annually.'}, {'id': 'OG001', 'title': 'Panavia 21 TC', 'description': '16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.\n\nPanavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.\n\nPatients were recalled after 6 and 12 months, and then annually.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Restoration was rebonded without any impairment of function', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Multilink', 'description': '14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system \\[A/B primer and Multilink-Automix\\] with Metal/Zirconia primer).\n\nMultilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).\n\nPatients were recalled after 6 and 12 months, and then annually.'}, {'id': 'FG001', 'title': 'Panavia 21 TC', 'description': '16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.\n\nPanavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.\n\nPatients were recalled after 6 and 12 months, and then annually.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': '5-Year Time Frame', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Multilink', 'description': '14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system \\[A/B primer and Multilink-Automix\\] with Metal/Zirconia primer).\n\nMultilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).\n\nPatients were recalled after 6 and 12 months, and then annually.'}, {'id': 'BG001', 'title': 'Panavia 21 TC', 'description': '16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.\n\nPanavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.\n\nPatients were recalled after 6 and 12 months, and then annually.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.57', 'spread': '16.84', 'groupId': 'BG000'}, {'value': '36.56', 'spread': '20.36', 'groupId': 'BG001'}, {'value': '33.3', 'spread': '18.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-04', 'studyFirstSubmitDate': '2011-08-03', 'resultsFirstSubmitDate': '2014-09-04', 'studyFirstSubmitQcDate': '2011-08-05', 'lastUpdatePostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-04', 'studyFirstPostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Final Loss of the Restauration', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Debonding of the RBFDP', 'timeFrame': '5 years', 'description': 'Restoration was rebonded without any impairment of function'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['All-Ceramic', 'Resin-bonded Fixed Dental Protheses', 'Single Retainer', 'Randomized Clinical Trial', 'Resin Bond', 'Bonding System'], 'conditions': ['Restauration in Situ', 'Final Loss of Restauration', 'Debonded Restauration']}, 'referencesModule': {'references': [{'pmid': '23930573', 'type': 'DERIVED', 'citation': 'Sasse M, Kern M. CAD/CAM single retainer zirconia-ceramic resin-bonded fixed dental prostheses: clinical outcome after 5 years. Int J Comput Dent. 2013;16(2):109-18. English, German.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective study was to evaluate the clinical outcome of all-ceramic RBFDP with a cantilevered single-retainer design made from zirconia ceramic. To evaluate the impact of the adhesive system used an established resin cement with an integrated adhesive monomer (Panavia 21 TC) and a resin cement with a separate primer (Multilink Automix with Metal/Zirconia Primer) were compared within the study on a randomized basis.\n\nThe aim of the present randomized study was to evaluate wether the difference in bond strength of Panavia and Multilink Automix with Metal/Zirconia Primer to densely sintered zirconia ceramic (IPS e.max ZirCAD, Ivoclar Vivadent) has any impact on the clinical outcome of all-ceramic RBFDP with a cantilevered single-retainer design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sufficient oral hygiene\n* one caries free or almost caries free abutment tooth available\n* sufficient space for the retainer wing available\n* patients willingness to return at regular intervals for at least 5 years for evaluation\n\nExclusion Criteria:\n\n* clinical symptoms of bruxism\n* collision, full or semi-contact sports (Boxing, Karate)\n* pregnant women\n* untreated advanced periodontitis'}, 'identificationModule': {'nctId': 'NCT01411592', 'briefTitle': 'Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses', 'organization': {'class': 'OTHER', 'fullName': 'University of Kiel'}, 'officialTitle': 'Randomized Clinical Trial on Single Retainer All-Ceramic Resin-bonded Fixed Dental Protheses: Impact of the Bonding System', 'orgStudyIdInfo': {'id': 'Ivoclar ZirCAD Adh.bruecken'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Multilink', 'description': 'RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system \\[A/B primer and Multilink-Automix\\] with Metal/Zirconia primer)', 'interventionNames': ['Other: Multilink']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Panavia 21 TC', 'description': 'RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer', 'interventionNames': ['Other: Panavia 21 TC']}], 'interventions': [{'name': 'Multilink', 'type': 'OTHER', 'otherNames': ['Multilink-Automix, Ivoclar Vivadent', 'Metal/Zirconia-Primer, Ivoclar Vivadent', 'A/B-Primer, Ivoclar Vivadent'], 'description': 'After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer)', 'armGroupLabels': ['Multilink']}, {'name': 'Panavia 21 TC', 'type': 'OTHER', 'otherNames': ['Panavia 21 TC, Kuraray'], 'description': 'After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer', 'armGroupLabels': ['Panavia 21 TC']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Matthias Kern, DDS, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Kiel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kiel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ivoclar Vivadent AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Martin Sasse, D.M.D., Assistant Professor', 'investigatorFullName': 'Martin Sasse', 'investigatorAffiliation': 'University of Kiel'}}}}