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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06441032
Other study ID # Survival-Cast-Restorations
Secondary ID 21/11/22
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date June 2025

Study information

Verified date June 2024
Source University of Göttingen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

No patient treatment is associated with the study.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 4000
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No patient treatment is associated with the study
No patient treatment is associated with the study.

Locations

Country Name City State
Germany University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology Göttingen Lower Saxony

Sponsors (1)

Lead Sponsor Collaborator
University of Göttingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success of restoration Success is defined as the time-interval without a subsequent re-intervention of the restoration or extraction of the tooth. 1997-2023
Secondary Survival of restoration Survival is defined as the time-interval without replacement of the restoration or extraction of the tooth. 1997-2023
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