Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-02 @ 2:50 AM
Study NCT ID:
NCT06441058
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: Influence of Post-endodontic Restoration Placement on Survival of Root Canal-treated Teeth
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': 1000}, '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 endodontic treatment', 'timeFrame': '1998-2023', 'description': 'Success is defined as the time-interval without a subsequent endodontic re-intervention or extraction of the tooth.'}], 'secondaryOutcomes': [{'measure': 'Survival of the tooth', 'timeFrame': '1998-2023', 'description': 'Survival of the tooth is defined as the time-interval without extraction of the tooth.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Root Canal Treatment']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the influence (i.e. type and timing) of post-endodontic restorations on the survival of root canal-treated teeth and to determine the influence of patient-, tooth-, treatment-, and restoration-specific parameters on longevity.\n\nPatients who received a root-canal treatment between 1998 and 1999 with subsequent placement of an indirect restoration (e.g. crown, partial crown) 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 root-canal treatments 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who received a root-canal treatment followed by the placement of an indirect post-endodontic restoration (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1998 and 1999.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who received a root-canal treatment followed by the placement of an indirect post-endodontic restoration (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1998 and 1999.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT06441058', 'briefTitle': 'Retrospective Database Study: Influence of Post-endodontic Restoration Placement on Survival of Root Canal-treated Teeth', 'organization': {'class': 'OTHER', 'fullName': 'University of Göttingen'}, 'officialTitle': 'Influence of the Timing of Post-endodontic Restoration Placement on the Survival of Root Canal-treated Teeth', 'orgStudyIdInfo': {'id': 'Timing-post-endodontic'}, 'secondaryIdInfos': [{'id': '20/2/20', 'type': 'OTHER', 'domain': 'Local Ethics Commission'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Indirect post-endodontic restorations', 'description': 'Indirect post-endodontic restorations (e.g. crown, partial crown).', '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': ['Indirect post-endodontic restorations']}]}, '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'}}}}