Patients' Preferences for Repair Versus Replacement Restorations

November 4, 2020 updated by: Philipp Kanzow, Dr. med. dent., Dr. rer. medic., University of Göttingen
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2017

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (ESTIMATE)

November 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Repair-Patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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