- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02975635
Patients' Preferences for Repair Versus Replacement Restorations
Study Overview
Detailed Description
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.
Recent 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.
Further 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
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Lower Saxony
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Göttingen, Lower Saxony, Germany, 37075
- University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Participant are selected by consecutive patient sampling.
Inclusion Criteria:
- At least one partially defective dental restoration which can either be repaired or replaced
Exclusion Criteria:
- Non-fulfillment of the inclusion criteria
- Lack of capacity to consent
- No German language skills in written and spoken language
- Age <18 years
- Defective restoration must be completely replaced in any event or is not suitable for repair
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Oral patient information only
Patients are given oral information only (information as usual).
After patients have made their decisions (repair or replacement), a questionnaire survey is conducted.
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Patients are given a questionnaire with items related to personality and behaviour.
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Written patient education before oral patient information
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.
|
Patients are given a questionnaire with items related to personality and behaviour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Completion of a questionnaire
Time Frame: 15 minutes
|
15 minutes
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Repair-Patients
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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