Patients' Preferences for Repair Versus Replacement Restorations

Sponsor
University of Göttingen (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02975635
Collaborator
Georg-Elias-Mueller-Institute of Psychology, University Goettingen (Other), Charite University, Berlin, Germany (Other)
100
1
50.6
2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Patients' Preferences for Repair Versus Replacement Restorations
Actual Study Start Date :
Mar 15, 2017
Anticipated Primary Completion Date :
Jan 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm 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.

Other: Questionnaire
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.

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

Outcome Measures

Primary Outcome Measures

  1. Completion of a questionnaire [15 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology Göttingen Lower Saxony Germany 37075

Sponsors and Collaborators

  • University of Göttingen
  • Georg-Elias-Mueller-Institute of Psychology, University Goettingen
  • Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Annette Wiegand, Prof. Dr. med. dent., Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Philipp Kanzow, Dr. med. dent., Dr. rer. medic., Dr. med. dent., University Medical Center Goettingen
ClinicalTrials.gov Identifier:
NCT02975635
Other Study ID Numbers:
  • Repair-Patients
First Posted:
Nov 29, 2016
Last Update Posted:
Nov 5, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Philipp Kanzow, Dr. med. dent., Dr. rer. medic., Dr. med. dent., University Medical Center Goettingen

Study Results

No Results Posted as of Nov 5, 2020