Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-13 @ 10:26 PM
Study NCT ID:
NCT02197312
Status:
TERMINATED
Last Update Posted:
2017-03-30
First Post:
2014-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NobelProceraTM Bridge Shaded Zirconia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'Business reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2014-07-03', 'studyFirstSubmitQcDate': '2014-07-18', 'lastUpdatePostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'esthetic performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region as determined by overall patient satisfaction survey', 'timeFrame': 'yearly up to 5 years'}], 'primaryOutcomes': [{'measure': 'clinical performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region with the proportion of patients with CDA ratings "R" (excellent) or "S"(acceptable)', 'timeFrame': 'yearly up to 5 years'}], 'secondaryOutcomes': [{'measure': 'survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region', 'timeFrame': 'yearly up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['yttrium-oxide', 'Y-TZP', 'bridge', 'NobelProcera', 'Shaded Zirconia'], 'conditions': ['Posterior Bridge Restoration']}, 'descriptionModule': {'briefSummary': 'Industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings and a sufficient survival rate after 5 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion.\n* The subject is healthy and compliant with good oral hygiene\n* The subject is in need of a posterior fixed partial denture restoration 3 or 4 units distal of the canines in the maxilla or mandible.\n* The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.\n* Obtained informed consent from the subject prior to the study.\n* No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.\n* Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.\n* The subject should be available for the 5-year term of the investigation.\n\nExclusion Criteria:\n\n* The subject is not able to give her/his informed consent to participate.\n* Alcohol or drug abuse as noted in patient records or in patient history.\n* Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.\n* An existing condition where acceptable retention of the restoration is impossible to attain\n* Mobility greater than grade 1 of the tooth to be restored.\n* Pathologic pocket formation of 4 mm or greater around the tooth to be restored\n* Severe bruxism or other destructive habits\n* Amount of attached soft tissue is insufficient (attached gingiva less than 2 mm or attachment loss greater than half of the root length).\n* Health conditions, which do not permit the restorative procedure"}, 'identificationModule': {'nctId': 'NCT02197312', 'briefTitle': 'NobelProceraTM Bridge Shaded Zirconia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nobel Biocare'}, 'officialTitle': 'A Clinical Evaluation of NobelProceraTM Bridge Shaded Zirconia', 'orgStudyIdInfo': {'id': 'T-159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'NobelProcera Bridge Shaded Zirconia', 'description': 'posterior region', 'interventionNames': ['Device: NobelProcera Bridge Shaded Zirconia']}], 'interventions': [{'name': 'NobelProcera Bridge Shaded Zirconia', 'type': 'DEVICE', 'armGroupLabels': ['NobelProcera Bridge Shaded Zirconia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinikum Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nobel Biocare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}