Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-02 @ 5:21 AM
Study NCT ID:
NCT06600451
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Data Collection on NobelProcera® Zirconia Implant Bridges from 4 to 14 Units.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-13', 'studyFirstSubmitDate': '2024-09-09', 'studyFirstSubmitQcDate': '2024-09-13', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complications', 'timeFrame': 'from bridge placement to last follow-up (up to 36 months follow-up)', 'description': 'biological and technical complications'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental prosthesis', 'NobelProcera', 'implant supported prosthesis', 'zirconia bridge'], 'conditions': ['Dental Prosthesis, Implant-Supported']}, 'descriptionModule': {'briefSummary': 'This is a retrospective multicenter data collection in which clinical and radiographic data on implant zirconia bridges are collected from partially or fully edentulous subjects consecutively treated with at least one 4- to 14-unit NobelProcera® Zirconia Implant Bridge. This data collection will be conducted in up to 11 centers (see Appendix I) and will include between 150 to 200 subjects.\n\nThe aim of this retrospective multicenter data collection is to evaluate the safety, performance, and clinical benefits of NobelProcera® Zirconia Implant Bridges (4 to 14 units) in daily dental practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with at least one NobelProcera Zirconia Implant Bridge from 4- to 14-unit.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject was at least 18 years old at the time of treatment,\n* Subjects treated with at least one NobelProcera® Zirconia Implant Bridge (4- to 14-unit supported by 2 to 10 implants).\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06600451', 'briefTitle': 'A Retrospective Data Collection on NobelProcera® Zirconia Implant Bridges from 4 to 14 Units.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nobel Biocare'}, 'officialTitle': 'A Retrospective Multicenter Clinical Data Collection to Evaluate the Safety, Performance, and Clinical Benefits of NobelProcera® Zirconia Implant Bridges from 4 to 14 Units in Daily Dental Practice', 'orgStudyIdInfo': {'id': '2020-1690'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with NobelProcera Zr Implant Bridge (4-14-unit)', 'description': 'Patients partially and fully edentulous in need of the implant supported dental prosthesis treated with NobelProcera Zr Implant Bridge (4-14-unit) from June 2020.\n\nDevice is CE and available on the market in May 2020.', 'interventionNames': ['Other: observational study, no intervention is required']}], 'interventions': [{'name': 'observational study, no intervention is required', 'type': 'OTHER', 'description': 'Retrospective chart review, investigators provides data after reviewing patient\\'s existing medical record; no interaction with patients is required.\n\nPatients were treated as per standard of care', 'armGroupLabels': ['Patients treated with NobelProcera Zr Implant Bridge (4-14-unit)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8302', 'city': 'Kloten', 'country': 'Switzerland', 'facility': 'Nobel Biocare Sevices AG', 'geoPoint': {'lat': 47.45152, 'lon': 8.58491}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nobel Biocare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}