Retrospective Database Study: Survival of Cast Restorations - Restorations Made of Precious Metal vs. Non-precious Metal

June 5, 2024 updated by: Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic., University of Göttingen

Survival of Cast Restorations - Restorations Made of Precious Metal vs. Non-precious Metal

The aim of this study is to determine and compare the longevity of single-tooth cast restorations made of precious metal vs. non-precious metal (e.g. partial crowns, crowns) and to determine the influence of patient-, tooth-, treatment-, and restoration-specific parameters on longevity.

Patients who received single-tooth cast restorations made of precious metal or non-precious metal (e.g. partial crowns, crowns) between 1997 and 2022 will be retrospectively analyzed. Patient-, tooth-, treatment-, and restoration-specific parameters will be obtained from digital and paper-based dental records.

Survival and success of the restorations will be assessed using Kaplan-Meier statistics. Mean annual failure rates (mAFR) and median survival time will be calculated (Kaplan-Meier statistics). Potential predictive factors will be tested using log-rank tests and multi-variate Cox-regression analysis.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

No patient treatment is associated with the study.

Study Type

Observational

Enrollment (Estimated)

4000

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

  • Germany
    • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients insured in the statutory health insurance who received single-tooth cast restorations made of precious metal or non-precious metal (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1997 and 2022.

Description

Inclusion Criteria:

  • Patients insured in the statutory health insurance.
  • Patients who received single-tooth cast restorations made of precious metal or non-precious metal (e.g. partial crowns, crowns) within the Department of Preventive Dentistry, Periodontology and Cariology between 1997 and 2022.

Exclusion Criteria:

  • None.

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
Precious metal
Single-tooth cast restorations made of precious metal.
Other: No patient treatment is associated with the study
No patient treatment is associated with the study.
Non-precious metal
Single-tooth cast restorations made of non-precious metal
Other: No patient treatment is associated with the study
No patient treatment is associated with the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of restoration
Time Frame: 1997-2023
Success is defined as the time-interval without a subsequent re-intervention of the restoration or extraction of the tooth.
1997-2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival of restoration
Time Frame: 1997-2023
Survival is defined as the time-interval without replacement of the restoration or extraction of the tooth.
1997-2023

Collaborators and Investigators

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

Sponsor

University of Göttingen

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)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Survival-Cast-Restorations
  • 21/11/22 (Other Identifier: Local Ethics Commission)

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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