Zirconia Based Fixed Dental ProsthesesNCT02220764
Zirconia Based Fixed Dental Prostheses
A study testing Teeth abutment and Implant abutments in people with Zirconia Based Fixed Dental Prostheses, run by Technische Universität Dresden.
Trial summary
The objective of this prospective clinical study is to investigate the differences in the complication rates between tooth- and implant- supported zirconia based fixed dental prostheses (FDPs) with at least 4 units. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Zirconia Based Fixed Dental Prostheses
- What is being tested?
- Teeth abutment and Implant abutments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 18 years
- Missing of at least two adjacent teeth in the maxilla or mandibular
- Sufficient oral hygiene
Who cannot join
- Addiction to alcohol or drugs
- Severe craniomandibular disorders
- Severe systematic diseases
- Patients unable or unwilling to sign the informed consent form
- Untreated periodontitis
About this study
Official title: Prospective Evaluation of Zirconia Based Tooth- and Implant- Supported Fixed Dental Prostheses
The objective of this prospective clinical study is to investigate the differences in the complication rates between tooth- and implant- supported zirconia based fixed dental prostheses (FDPs) with at least 4 units. The null-hypothesis is that there is no difference in the complication rates between implant- supported and tooth- supported zirconia FDPs.
Read the detailed description
The study aims to provide evidence regarding the clinical behaviour of long-span tooth- and implant-supported FDPs.
- Conditions
- Zirconia Based Fixed Dental Prostheses
- Being tested
- Teeth abutment, Implant abutments
- Keywords
- prospective study, chipping, survival rate, fracture resistance, zirconia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teeth abutmentDevice
Also called Zenotec system
Implant abutmentsDevice
Also called Zenotec system, Wital (Implant system)
| Study group | Role | What they receive |
|---|---|---|
| Tooth-supported | Experimental | Long-span tooth-supported zirconia based fixed dental prostheses Receives: Device: Teeth abutment |
| Implant-supported | Active comparator | Long-span implant-supported zirconia based fixed dental prostheses Receives: Device: Implant abutments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Fixed Dental Prostheses (FDPs) With Failure
"Failure" was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period.
Measured: 3 years
Secondary outcomes (1)
Number of Fixed Dental Prostheses (FDPs) With Chip/s
Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startMay 2008
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Zirconia Based Fixed Dental ProsthesesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220764
- Sponsor's protocol ID
- W-008
- Status last verified
- Mar 2015
- First submitted
- 16 Jul 2014
- Last updated
- 24 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Konstantinidis IK, Jacoby S, Radel M, Boning K. Prospective evaluation of zirconia based tooth- and implant-supported fixed dental prostheses: 3-year results. J Dent. 2015 Jan;43(1):87-93. doi: 10.1016/j.jdent.2014.10.011. Epub 2014 Nov 5.
PubMed 25446240
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Zirconia Based Tooth- and Implant- Supported Fixed Dental Prostheses
- ClinicalTrials.gov ID
- NCT02220764
- Acronym / sponsor ID
- W-008
- Conditions
- Zirconia Based Fixed Dental Prostheses
- Keywords
- prospective study, chipping, survival rate, fracture resistance, zirconia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Posted 24 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this prospective clinical study is to investigate the differences in the complication rates between tooth- and implant- supported zirconia based fixed dental prostheses (FDPs) with at least 4 units. The null-hypothesis is that there is no difference in the complication rates between implant- supported and tooth- supported zirconia FDPs.
Detailed description
The study aims to provide evidence regarding the clinical behaviour of long-span tooth- and implant-supported FDPs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tooth-supported | Experimental | Device: Teeth abutmentLong-span tooth-supported zirconia based fixed dental prostheses |
| Implant-supported | Active comparator | Device: Implant abutmentsLong-span implant-supported zirconia based fixed dental prostheses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Missing of at least two adjacent teeth in the maxilla or mandibular
- Sufficient oral hygiene
Key exclusion criteria (5 listed)
- Addiction to alcohol or drugs
- Severe craniomandibular disorders
- Severe systematic diseases
- Patients unable or unwilling to sign the informed consent form
- Untreated periodontitis
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 |
|---|---|---|
| Teeth abutmentAlso: Zenotec system | Device | Tooth-supported |
| Implant abutmentsAlso: Zenotec system, Wital (Implant system) | Device | Implant-supported |
Primary outcome
Number of Fixed Dental Prostheses (FDPs) With Failure
Time frame: 3 years
"Failure" was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period.
1 secondary outcome
Number of Fixed Dental Prostheses (FDPs) With Chip/s
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25446240Konstantinidis IK, Jacoby S, Radel M, Boning K. Prospective evaluation of zirconia based tooth- and implant-supported fixed dental prostheses: 3-year results. J Dent. 2015 Jan;43(1):87-93. doi: 10.1016/j.jdent.2014.10.011. Epub 2014 Nov 5.
Related trials for Zirconia Based Fixed Dental Prostheses
Recruiting
Two-unit Cantilever Implant Prostheses Made of Monolithic Zirconia or PFM
Jaw, Edentulous, Partially, Missing Teeth
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.
Questions about this trial
What is this clinical trial studying?
A study testing Teeth abutment and Implant abutments in people with Zirconia Based Fixed Dental Prostheses, run by Technische Universität Dresden.
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 5 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 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 24 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Fixed Dental Prostheses (FDPs) With Failure (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02220764, which also lists 1 linked publication.
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 24 Mar 2015.