Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT02975635
Status:
UNKNOWN
Last Update Posted:
2020-11-05
First Post:
2016-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients' Preferences for Repair Versus Replacement Restorations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057240', 'term': 'Patient Preference'}], 'ancestors': [{'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2016-11-23', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of a questionnaire', 'timeFrame': '15 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Patients' Preferences"], 'conditions': ['Patient Preference']}, 'referencesModule': {'references': [{'pmid': '26796700', 'type': 'BACKGROUND', 'citation': "Schwendicke F, Mostajaboldave R, Otto I, Dorfer CE, Burkert S. Patients' preferences for selective versus complete excavation: A mixed-methods study. J Dent. 2016 Mar;46:47-53. doi: 10.1016/j.jdent.2016.01.006. Epub 2016 Jan 18."}, {'pmid': '25009685', 'type': 'BACKGROUND', 'citation': 'Weeks L, Balneaves LG, Paterson C, Verhoef M. Decision-making about complementary and alternative medicine by cancer patients: integrative literature review. Open Med. 2014 Apr 15;8(2):e54-66. eCollection 2014.'}, {'pmid': '24408309', 'type': 'BACKGROUND', 'citation': 'Ernst J, Brahler E, Weissflog G. [Patient involvement in medical decision making--an overview on patient preferences and impacting factors]. Gesundheitswesen. 2014 Apr;76(4):187-92. doi: 10.1055/s-0033-1361150. Epub 2014 Jan 9. German.'}, {'pmid': '27255959', 'type': 'BACKGROUND', 'citation': 'Kanzow P, Hoffmann R, Tschammler C, Kruppa J, Rodig T, Wiegand A. Attitudes, practice, and experience of German dentists regarding repair restorations. Clin Oral Investig. 2017 May;21(4):1087-1093. doi: 10.1007/s00784-016-1859-3. Epub 2016 Jun 2.'}, {'pmid': '27575986', 'type': 'BACKGROUND', 'citation': 'Kanzow P, Wiegand A, Schwendicke F. Cost-effectiveness of repairing versus replacing composite or amalgam restorations. J Dent. 2016 Nov;54:41-47. doi: 10.1016/j.jdent.2016.08.008. Epub 2016 Aug 26.'}]}, 'descriptionModule': {'briefSummary': "Partially defective dental restorations might either be treated by complete replacement or by repair of the affected region. Repair restorations are a scientifically proven approach to manage failed restorations, but probably unknown to most patients. Results from this study and findings on the predictors of patients' therapy decisions might improve future patient information documents.", 'detailedDescription': "Handling insufficient restorations contributes up to 2/3 of all treatments in dentistry. Formerly, defective restorations were completely removed and replaced. Today, repair restorations are an alternative choice. During repair treatment, only the defective portion of a restoration (instead of the complete restoration) is removed and replaced. By performing repair restorations dental hard tissue can be conserved and the risk of treatment associated complications is reduced.\n\nRecent studies have shown that survival rates of repair restorations are slightly lower compared to replacement fillings. Nevertheless, in certain clinical situations repair restorations are more cost-effective than replacement.\n\nFurther studies have shown that patients' decisions differ with regard to a variety of factors. This applies to decisions regarding dental treatments as well. However, patients' decisions between both possible therapy options (repair or replacement) of partially defective restorations are not yet investigated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany', 'healthyVolunteers': False, 'eligibilityCriteria': 'Participant are selected by consecutive patient sampling.\n\nInclusion Criteria:\n\n* At least one partially defective dental restoration which can either be repaired or replaced\n\nExclusion Criteria:\n\n* Non-fulfillment of the inclusion criteria\n* Lack of capacity to consent\n* No German language skills in written and spoken language\n* Age \\<18 years\n* Defective restoration must be completely replaced in any event or is not suitable for repair'}, 'identificationModule': {'nctId': 'NCT02975635', 'briefTitle': "Patients' Preferences for Repair Versus Replacement Restorations", 'organization': {'class': 'OTHER', 'fullName': 'University of Göttingen'}, 'officialTitle': "Patients' Preferences for Repair Versus Replacement Restorations", 'orgStudyIdInfo': {'id': 'Repair-Patients'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oral patient information only', 'description': 'Patients are given oral information only (information as usual). After patients have made their decisions (repair or replacement), a questionnaire survey is conducted.', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Written patient education before oral patient information', 'description': 'Patients are given a flow chart in advance of oral information. After patients have made their decisions (repair or replacement), a questionnaire survey is conducted.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Patients are given a questionnaire with items related to personality and behaviour.', 'armGroupLabels': ['Oral patient information only', 'Written patient education before oral patient information']}]}, '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}}], 'overallOfficials': [{'name': 'Annette Wiegand, Prof. Dr. med. dent.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Göttingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Georg-Elias-Mueller-Institute of Psychology, University Goettingen', 'class': 'UNKNOWN'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. dent.', 'investigatorFullName': 'Philipp Kanzow, Dr. med. dent., Dr. rer. medic.', 'investigatorAffiliation': 'University Medical Center Goettingen'}}}}