NCT02975635

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

3.8 years

First QC Date

November 23, 2016

Last Update Submit

November 4, 2020

Conditions

Patient Preference

Keywords

Patients' Preferences

Outcome Measures

Primary Outcomes (1)

  • Completion of a questionnaire

    15 minutes

Study Arms (2)

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

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

Interventions

QuestionnaireOTHER

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

Oral patient information onlyWritten patient education before oral patient information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Göttingen, Lower Saxony, 37075, Germany

Location

Related Publications (5)

  • 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: 26796700BACKGROUND

  • 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: 25009685BACKGROUND

  • 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: 24408309BACKGROUND

  • 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: 27255959BACKGROUND

  • 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.

    PMID: 27575986BACKGROUND

MeSH Terms

Conditions

Patient Preference

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Patient SatisfactionTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Annette Wiegand, Prof. Dr. med. dent.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. dent.

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 29, 2016

Study Start

March 15, 2017

Primary Completion

January 1, 2021

Study Completion

June 1, 2021

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)