MedDataX Logo

Patients' Preferences for Repair Versus Replacement Restorations

NCT ID: NCT02975635

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-15

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patient Preference

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Questionnaire

Intervention Type OTHER

Patients are given a questionnaire with items related to personality and behaviour.

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.

Questionnaire

Intervention Type OTHER

Patients are given a questionnaire with items related to personality and behaviour.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire

Patients are given a questionnaire with items related to personality and behaviour.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* At least one partially defective dental restoration which can either be repaired or replaced

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Georg-Elias-Mueller-Institute of Psychology, University Goettingen

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

University of Göttingen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Philipp Kanzow, Dr. med. dent., Dr. rer. medic.

Dr. med. dent.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Annette Wiegand, Prof. Dr. med. dent.

Role: PRINCIPAL_INVESTIGATOR

Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology

Göttingen, Lower Saxony, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26796700 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25009685 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24408309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27255959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27575986 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Repair-Patients

Identifier Type: -

Identifier Source: org_study_id