Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:21 PM
Study NCT ID:
NCT01464294
Status:
TERMINATED
Last Update Posted:
2024-12-02
First Post:
2011-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'whyStopped': 'not a required sutudy to be posted', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2011-10-27', 'studyFirstSubmitQcDate': '2011-11-02', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical performance', 'timeFrame': '3 years', 'description': 'Subjective evaluation of restorations using USPHS criteria'}], 'secondaryOutcomes': [{'measure': 'Luting cement', 'timeFrame': '3 years', 'description': 'Subjective evaluaton of performance of a nano-filled resin luting cement used to cement the study onlays'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CAD/CAM', 'crowns', 'onlays', 'composite block', 'milled restorations'], 'conditions': ['Restoration of Posterior Teeth']}, 'descriptionModule': {'briefSummary': 'Study aim is to test whether nano-composite CAD/CAM milled restorations have a similar performance in clinical service to conventional ceramic CAD/CAM restorations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending and/or under clinical treatment at the University of Michigan Dental Clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient 18 years of age or over\n* To have at least one carious lesion or defective restoration in a molar or premolar tooth, cavities to be large enough to warrant a milled restoration of either a crown or onlay\n* Teeth to be vital and asymptomatic\n\nExclusion Criteria:\n\n* Devital or sensitive teeth\n* Teeth that have had root canal treatment\n* Patients with significant untreated dental disease including periodontitis and rampant caries\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01464294', 'briefTitle': 'Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': 'Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations', 'orgStudyIdInfo': {'id': '3M ESPE CR-10-019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'nano-composite', 'description': 'crowns and onlays', 'interventionNames': ['Device: Milled nano-composite restorations']}, {'label': 'ceramic', 'description': 'crowns \\& onlays', 'interventionNames': ['Device: Milled ceramic restorations']}], 'interventions': [{'name': 'Milled ceramic restorations', 'type': 'DEVICE', 'otherNames': ['Empress CAD/CAM leucite porcelain (Ivoclar Vivadent)'], 'description': 'Restoration of back teeth with milled ceramic crowns or onlays', 'armGroupLabels': ['ceramic']}, {'name': 'Milled nano-composite restorations', 'type': 'DEVICE', 'otherNames': ['Lava Ultimate CAD/CAM Restorative (3M ESPE)'], 'description': 'Restoration of back teeth with milled crowns or onlays', 'armGroupLabels': ['nano-composite']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'School of Dentistry, Unversity of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Dennis Fasbinder, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Dentistry, Univ of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solventum US LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}