Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-01-01 @ 8:10 PM
Study NCT ID:
NCT06441032
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-07
First Post:
2024-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Database Study: Survival of Cast Restorations - Restorations Made of Precious Metal vs. Non-precious Metal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2024-05-28', 'studyFirstSubmitQcDate': '2024-05-28', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of restoration', 'timeFrame': '1997-2023', 'description': 'Success is defined as the time-interval without a subsequent re-intervention of the restoration or extraction of the tooth.'}], 'secondaryOutcomes': [{'measure': 'Survival of restoration', 'timeFrame': '1997-2023', 'description': 'Survival is defined as the time-interval without replacement of the restoration or extraction of the tooth.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Restoration Failure']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine and compare the longevity of single-tooth cast restorations made of precious metal vs. non-precious metal (e.g. partial crowns, crowns) and to determine the influence of patient-, tooth-, treatment-, and restoration-specific parameters on longevity.\n\nPatients who received single-tooth cast restorations made of precious metal or non-precious metal (e.g. partial crowns, crowns) between 1997 and 2022 will be retrospectively analyzed. Patient-, tooth-, treatment-, and restoration-specific parameters will be obtained from digital and paper-based dental records.\n\nSurvival and success of the restorations will be assessed using Kaplan-Meier statistics. Mean annual failure rates (mAFR) and median survival time will be calculated (Kaplan-Meier statistics). Potential predictive factors will be tested using log-rank tests and multi-variate Cox-regression analysis.', 'detailedDescription': 'No patient treatment is associated with the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients insured in the statutory health insurance who received single-tooth cast restorations made of precious metal or non-precious metal (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1997 and 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients insured in the statutory health insurance.\n* Patients who received single-tooth cast restorations made of precious metal or non-precious metal (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1997 and 2022.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT06441032', 'briefTitle': 'Retrospective Database Study: Survival of Cast Restorations - Restorations Made of Precious Metal vs. Non-precious Metal', 'organization': {'class': 'OTHER', 'fullName': 'University of Göttingen'}, 'officialTitle': 'Survival of Cast Restorations - Restorations Made of Precious Metal vs. Non-precious Metal', 'orgStudyIdInfo': {'id': 'Survival-Cast-Restorations'}, 'secondaryIdInfos': [{'id': '21/11/22', 'type': 'OTHER', 'domain': 'Local Ethics Commission'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Precious metal', 'description': 'Single-tooth cast restorations made of precious metal.', 'interventionNames': ['Other: No patient treatment is associated with the study']}, {'label': 'Non-precious metal', 'description': 'Single-tooth cast restorations made of non-precious metal', 'interventionNames': ['Other: No patient treatment is associated with the study']}], 'interventions': [{'name': 'No patient treatment is associated with the study', 'type': 'OTHER', 'description': 'No patient treatment is associated with the study.', 'armGroupLabels': ['Non-precious metal', 'Precious metal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37075', 'city': 'Göttingen', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Göttingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic.', 'investigatorAffiliation': 'University Medical Center Goettingen'}}}}