Tooth Loss, Teeth Replaced Using All Ceramic FPDsNCT00176189
Clinical Performance of Extended All-Ceramic Fixed Partial Dentures Based on Zircon-Oxide Ceramics.
A study testing All ceramic FPDs in people with Tooth Loss, Teeth Replaced Using All Ceramic FPDs, run by Heidelberg University at 1 site in Germany.
Trial summary
Fixed-partial dentures fabricated of zircon-oxide ceramics were introduced in dentistry some time ago. However, the survival rate of all-ceramic extended (up to 47mm) fixed-partial dentures is unknown. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tooth Loss, Teeth Replaced Using All Ceramic FPDs
- What is being tested?
- All ceramic FPDs
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2005to Dec 2006
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients older 18 years
- At least two missing posterior teeth
- Tooth wear<3
Who cannot join
- Bruxism
- Mental disorders
- Pregnancy
- Tooth mobility>1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Extended All-Ceramic Fixed Partial Dentures Based on Zircon-Oxide Ceramics
Fixed-partial dentures fabricated of zircon-oxide ceramics were introduced in dentistry some time ago. However, the survival rate of all-ceramic extended (up to 47mm) fixed-partial dentures is unknown.
The hypothesis was that long FDPs fabricated of zirkon-oxide withstand masticatory forces in the posterior and anterior regio of the jaw.
Read the detailed description
30 patients with at least 2 missing posterior or anterior teeth will be included in the study. All patients will receive all-ceramic fixed partial dentures.
- Being tested
- All ceramic FPDs
- Keywords
- FPD, all-ceramic
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All ceramic FPDsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate of the FPDs
Secondary outcomes (1)
Esthetical and functional performance of the FPDs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Loss, Teeth Replaced Using All Ceramic FPDsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Peter Rammelsberg, Prof. Dr., Principal investigator, Department of prosthodontics, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176189
- Sponsor's protocol ID
- Cercon-giant
- Status last verified
- Sep 2006
- First submitted
- 12 Sep 2005
- Last updated
- 26 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Extended All-Ceramic Fixed Partial Dentures Based on Zircon-Oxide Ceramics
- ClinicalTrials.gov ID
- NCT00176189
- Acronym / sponsor ID
- Cercon-giant
- Keywords
- FPD, all-ceramic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Feb 2005
- Study completion
- Dec 2006
- First posted
- 15 Sep 2005 (estimated)
- 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.
Fixed-partial dentures fabricated of zircon-oxide ceramics were introduced in dentistry some time ago. However, the survival rate of all-ceramic extended (up to 47mm) fixed-partial dentures is unknown.
The hypothesis was that long FDPs fabricated of zirkon-oxide withstand masticatory forces in the posterior and anterior regio of the jaw.
Detailed description
30 patients with at least 2 missing posterior or anterior teeth will be included in the study. All patients will receive all-ceramic fixed partial dentures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients older 18 years
- At least two missing posterior teeth
- Tooth wear<3
Key exclusion criteria (4 listed)
- Bruxism
- Mental disorders
- Pregnancy
- Tooth mobility>1
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 |
|---|---|---|
| All ceramic FPDs | Device | – |
Primary outcome
Survival rate of the FPDs
1 secondary outcome
Esthetical and functional performance of the FPDs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2006.
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.
Peter Rammelsberg, Prof. Dr. principal investigator
Department of prosthodontics, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All ceramic FPDs in people with Tooth Loss, Teeth Replaced Using All Ceramic FPDs, run by Heidelberg University 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 26 Sep 2006. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival rate of the FPDs. 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 26 Sep 2006.