NCT06441032

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

May 28, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

May 28, 2024

Last Update Submit

June 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Survival of restoration

    1997-2023

Study Arms (2)

Precious metal

Single-tooth cast restorations made of precious metal.

Other: 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

Interventions

No patient treatment is associated with the study.

Non-precious metalPrecious metal

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • None.

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 4, 2024

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations