Retrospective Database Study: Survival of Cast Restoratio... | NCT06441032

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

NCT06441032

Sponsor

University of Göttingen

Status

Unknown status

Last Update Posted

Jun 7, 2024Actual

Enrollment

4,000Estimated

Phase

Not provided

Conditions

Dental Restoration Failure

Interventions

No patient treatment is associated with the study

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
21/11/22	Other Identifier	Local Ethics Commission

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Actual

Primary Completion Date

Jun 2025Estimated

Completion Date

Jun 2025Estimated

First Submitted Date

May 28, 2024

First Submission Date that Met QC Criteria

May 28, 2024

First Posted Date

Jun 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2024

Last Update Posted Date

Jun 7, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic., Senior Lecturer, University Medical Center GoettingenPrincipal Investigator

Lead Sponsor

University of GöttingenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

No patient treatment is associated with the study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
No patient treatment is associated with the study	Other	No patient treatment is associated with the study.	Non-precious metal Precious metal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology		Göttingen	Lower Saxony	37075	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided