Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-26 @ 8:41 AM
Study NCT ID:
NCT02758457
Status:
COMPLETED
Last Update Posted:
2016-05-02
First Post:
2016-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zirconia and Metal-based Single Crown Posterior Restorations.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003442', 'term': 'Crowns'}], 'ancestors': [{'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-28', 'studyFirstSubmitDate': '2016-04-23', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical complication rate', 'timeFrame': '5 years', 'description': 'assessed by USPHS-criteria'}], 'secondaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': '1, 3, 5 years', 'description': 'assessed by bleeding on probing'}, {'measure': 'Survival rate', 'timeFrame': '1, 3, 5 years', 'description': 'pocket probing depth'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cad/cam', 'dental porcelain', 'zirconia', 'press on metal'], 'conditions': ['Dental Crowns', 'Dental Prosthesis', 'Prosthodontics']}, 'referencesModule': {'references': [{'pmid': '28736293', 'type': 'DERIVED', 'citation': 'Monaco C, Llukacej A, Baldissara P, Arena A, Scotti R. Zirconia-based versus metal-based single crowns veneered with overpressing ceramic for restoration of posterior endodontically treated teeth: 5-year results of a randomized controlled clinical study. J Dent. 2017 Oct;65:56-63. doi: 10.1016/j.jdent.2017.07.004. Epub 2017 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to compare the 5-year survival and clinical behavior of single posterior ceramic crowns made with pressable ceramic on zirconia or on a metal framework. If failures occurred, the further aim of the study was to delineate the factors contributing to the failure. The null hypothesis stated that the survival of zirconia-based restorations would be no worse that those made with metal-based material.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent as documented by signature\n* Male and female patients from 18-70 years of age\n* Need for a single crown restoration\n* Presence of antagonist\n* minimum of 20 teeth\n* moderate to good oral hygiene with the ability to perform mechanical oral hygiene techniques including tooth brushing\n* low to moderate caries risk, and no active periodontal disease.\n\nExclusion Criteria:\n\n* Women who are pregnant at the date of inclusion\n* Known or suspected non-compliance, drug or alcohol abuse\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant\n* Smoking more than 15 cigarettes a day\n* Poor oral hygiene (Plaque Index over 30%)\n* Bruxism\n* vital teeth\n* allergic reaction or hypersensitivity to ingredients of the adhesive or restorative material'}, 'identificationModule': {'nctId': 'NCT02758457', 'briefTitle': 'Zirconia and Metal-based Single Crown Posterior Restorations.', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'Zirconia-based and Metal-based Single Crown Posterior Restorations: 5-year Results of a Randomized Controlled Clinical Study.', 'orgStudyIdInfo': {'id': '222893'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'metal-based restorations', 'description': 'single crown with a metal framework and pressed ceramic', 'interventionNames': ['Device: dental crowns']}, {'type': 'EXPERIMENTAL', 'label': 'zirconia-based restorations', 'description': 'single crown with a zirconia framework and pressed ceramic', 'interventionNames': ['Device: dental crowns']}], 'interventions': [{'name': 'dental crowns', 'type': 'DEVICE', 'armGroupLabels': ['metal-based restorations', 'zirconia-based restorations']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40125', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Department of Biomedical and Neuromotor Sciences, Division of Prosthotontics and Maxilla-Facial Rehabilitation', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Carlo Monaco, DDS, PhD', 'investigatorFullName': 'carlo monaco', 'investigatorAffiliation': 'University of Bologna'}}}}