Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-16 @ 5:47 PM
Study NCT ID:
NCT04407520
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2020-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Database Study: Survival of Direct Composite Restorations Placed Under General Anesthesia in Adult Patients With Intellectual and/or Physical Disabilities and Risk Factors for Repeated Dental Treatment in General Anesthesia
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': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2020-05-25', 'studyFirstSubmitQcDate': '2020-05-25', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure of restoration placed under general anesthesia', 'timeFrame': '2011-2019', 'description': 'Failure is defined as the need for replacement of at least one surface of the original restoration or extraction of the tooth.'}], 'secondaryOutcomes': [{'measure': 'Repeated dental treatment under general anesthesia', 'timeFrame': '2011-2017'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intellectual and/or Physical Disabilities', 'Dental Treatment Under General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '33449193', 'type': 'RESULT', 'citation': 'Maes MS, Kanzow P, Hrasky V, Wiegand A. Survival of direct composite restorations placed under general anesthesia in adult patients with intellectual and/or physical disabilities. Clin Oral Investig. 2021 Jul;25(7):4563-4569. doi: 10.1007/s00784-020-03770-y. Epub 2021 Jan 15.'}, {'pmid': '34432139', 'type': 'RESULT', 'citation': 'Maes MS, Kanzow P, Biermann J, Leha A, Hrasky V, Wiegand A. Risk factors for repeated general anesthesia for dental treatment of adult patients with intellectual and/or physical disabilities. Clin Oral Investig. 2022 Feb;26(2):1695-1700. doi: 10.1007/s00784-021-04142-w. Epub 2021 Aug 25.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the survival of direct anterior and/or posterior composite restoration placed in general anesthesia in permanent teeth of adult patients with intellectual and/or physical disabilities. Further aim is to identify potential risk factors predicting repeated dental treatment under general anesthesia.\n\nSurvival of composite restorations placed under general anesthesia in adult patients with intellectual and/or physical disabilities between 2011 and 2019 will be retrospectively analysed. Failure is defined as the need for replacement of at least one surface of the original restoration or extraction of the tooth. Individual-, tooth- and restoration-related factors are obtained from digital and paper-based dental records. Mean annual failure rates (mAFR) and median survival time will be calculated (Kaplan-Meier statistics). The effect of potential risk factors on failure will be tested using univariate log-rank tests and multivariate Cox-regression analysis.\n\nAdult patients with intellectual and/or physical disabilities who received dental treatment under general anesthesia between 2011 and 2017 will be retrospectively analyzed. Demographic, anamnestic, oral health and treatment factors will be obtained from digital and paper-based dental records. Duration of intervals without a subsequent dental treatment under general anesthesia will be assessed using 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': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with intellectual and/or physical disabilities and need for dental treatment under general anesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with intellectual and/or physical disabilities that were treated under general anesthesia in the Department of Preventive Dentistry, Periodontology and Cariology between January 2011 and December 2019\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04407520', 'briefTitle': 'Retrospective Database Study: Survival of Direct Composite Restorations Placed Under General Anesthesia in Adult Patients With Intellectual and/or Physical Disabilities and Risk Factors for Repeated Dental Treatment in General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University of Göttingen'}, 'officialTitle': 'Survival of Direct Composite Restorations Placed Under General Anesthesia in Adult Patients With Intellectual and/or Physical Disabilities and Risk Factors for Repeated Dental Treatment in General Anesthesia of Adult Patients With Intellectual and/or Physical Disabilities', 'orgStudyIdInfo': {'id': 'Survival-Disabled'}, 'secondaryIdInfos': [{'id': '15/1/18', 'type': 'OTHER', 'domain': 'Local Ethics Commission'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients with intellectual and/or physical disabilities', 'description': 'Adult patients with intellectual and/or physical disabilities requiring dental treatment under general anesthesia', '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': ['Adult patients with intellectual and/or physical disabilities']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Göttingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Dental Practitioner', 'investigatorFullName': 'Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic.', 'investigatorAffiliation': 'University Medical Center Goettingen'}}}}