Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-25 @ 8:29 AM
Study NCT ID:
NCT03452358
Status:
COMPLETED
Last Update Posted:
2018-03-06
First Post:
2018-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survival Rate of Lithium Disilicate Crowns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-03', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-02-26', 'lastUpdatePostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': 'from 2006 to 2018'}], 'secondaryOutcomes': [{'measure': 'Quality of survival', 'timeFrame': 'from 2006 to 2018', 'description': 'according to Hickel'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Survival', 'Immediate Dentin Sealing']}, 'descriptionModule': {'briefSummary': 'A retrospective clinical study will be performed evaluating a large number of partial ceramic restorations (IPS e-Max press, Ivoclar, Liechtenstein) placed in general practice. Evaluation will be based on the well established Hickel criteria (Hickel et al, 2010). Rationale: IPS-e-max press has been made available to the market since 2006. Although millions of these restorations have been placed worldwide, clinical data are available of less than 200 single restorations only, covering observation periods of 2-8 years.(Guess et al, 2009; Etman en Woolford, 2010; Gehrt et al, 2012; Esquivel-Upshaw et al, 2012).\n\nObjective: Study the survival of lithium disilicate restorations during regular check-ups in a private dental practice.', 'detailedDescription': 'Study the survival of lithium disilicate restorations during regular check-ups in a private dental practice. All included patients were followed-up with special emphasis on the partial restoration(s), every time they visited the dental practice for regular dental check-ups between 2015 and 2017. To assess these restorations a light photograph with a digital camera (Nikon (D7100, 60mm lens), Nikon, Amsterdam, The Netherlands) and an x-ray were taken from the partial posterior crowns and evaluated according to the modified United States Public Health Service (USPHS) criteria.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients participating in this study will be recruited from the patient population of the private dental practice 'Buijs tandartsen' in Groningen, the Netherlands.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In order to be eligible to participate in this study, a patient must received one or more lithium disilicate restorations between 2006 and today.\n\nExclusion Criteria:\n\n* No patients will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT03452358', 'briefTitle': 'Survival Rate of Lithium Disilicate Crowns', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Clinical Evaluation of Partial Ceramic Posterior Restorations Cemented Using Immediate Dentin Sealing - a (#) Year Follow up From a Retrospective Study.', 'orgStudyIdInfo': {'id': '201500391'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Partial Ceramic Indirect restoration', 'type': 'PROCEDURE', 'otherNames': ['Immediate Dentin Sealing'], 'description': 'Placement of an partial ceramic indirect restoration with the use of immediate dentin sealing as an adjunct to adhesive cementation.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Carline van den Breemer', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}