Dental Restoration FailureNCT06441032
Retrospective Database Study: Survival of Cast Restorations - Restorations Made of Precious Metal vs. Non-precious Metal
An observational study of Dental Restoration Failure, run by University of Göttingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dental Restoration Failure
- What is being tested?
- No patient treatment is associated with the study
- How many people
- 4,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2024to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology
Göttingen, Lower Saxony, 37075
About this study
Official title: 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.
Read the detailed description
No patient treatment is associated with the study.
- Conditions
- Dental Restoration Failure
- Being tested
- No patient treatment is associated with the study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No patient treatment is associated with the studyOther
No patient treatment is associated with the study.
| Study group | Role | What they receive |
|---|---|---|
| Precious metal | Single-tooth cast restorations made of precious metal. Receives: Other: No patient treatment is associated with the study | |
| Non-precious metal | Single-tooth cast restorations made of non-precious metal Receives: Other: No patient treatment is associated with the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of restoration
Success is defined as the time-interval without a subsequent re-intervention of the restoration or extraction of the tooth.
Measured: 1997-2023
Secondary outcomes (1)
Survival of restoration
Survival is defined as the time-interval without replacement of the restoration or extraction of the tooth.
Measured: 1997-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jun 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Restoration FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic., University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441032
- Sponsor's protocol ID
- Survival-Cast-Restorations
- Other IDs
- 21/11/22
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival of Cast Restorations - Restorations Made of Precious Metal vs. Non-precious Metal
- ClinicalTrials.gov ID
- NCT06441032
- Acronym / sponsor ID
- Survival-Cast-Restorations
- Conditions
- Dental Restoration Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precious metal | – | Other: No patient treatment is associated with the studySingle-tooth cast restorations made of precious metal. |
| Non-precious metal | – | Other: No patient treatment is associated with the studySingle-tooth cast restorations made of non-precious metal |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No patient treatment is associated with the studyNo patient treatment is associated with the study. | Other | Non-precious metal, Precious metal |
Primary outcome
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.
1 secondary outcome
Survival of restoration
Time frame: 1997-2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Restoration Failure, run by University of Göttingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of restoration (time frame: 1997-2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.