Three-unit Posterior BridgesNCT02175329
Clinical Investigation on Zirconia-ceramic Three-unit Bridges With CAD-on Veneering
A study testing CAD/CAM Veneering and Manually layered veneering in people with Three-unit Posterior Bridges, run by Ivoclar Vivadent AG at 1 site in Switzerland.
Trial summary
60 bridge frameworks are CAD/CAM manufactured from zirconia-ceramic; 30 bridges are veneered with CAD/CAM fabricated lithium disilicate ceramic, 30 bridges are manually layered. The goal is to compare clinical survival , biological or technical behaviour of the restorations. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Three-unit Posterior Bridges
- What is being tested?
- CAD/CAM Veneering and Manually layered veneering
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to 31 Dec 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single missing posterior tooth with two adjacent posterior teeth
- no acute conservative or paradontal treatment need except for the teeth to be treated in the study
- sufficient oral hygiene
Who cannot join
- known allergies to components
- bruxism
- missing antagonist tooth
- pregnancy or lactation
- missing written consent
- patients which are not expected to be compliant
Show all 9Show fewer
- severe systemic diseases
- untreated carious lesions
- untreated parodontitis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universität Zürich, Zentrum für Zahn-, Mund- und Kieferheilkunde
Zurich, 8032
About this study
Official title: A Randomized Clinical Trial of 3-unit Posterior Zirconia-ceramic Fixed Dental Prosthesis (FDPs) Veneered With Layered and Milled (CAD-on) Veneering Ceramics
60 bridge frameworks are CAD/CAM manufactured from zirconia-ceramic; 30 bridges are veneered with CAD/CAM fabricated lithium disilicate ceramic, 30 bridges are manually layered. The goal is to compare clinical survival , biological or technical behaviour of the restorations.
Read the detailed description
Randomized prospective controlled clinical study with three-unit posterior bridges made of zirconia-ceramic to compare veneering with manually layering or CAD/CAM fabricated lithium disilicate ceramic veneers. The hypothesis is that there is no difference in clinical survival of the restorations and no difference in biological or technical behaviour.
- Conditions
- Three-unit Posterior Bridges
- Being tested
- CAD/CAM Veneering, Manually layered veneering
- Keywords
- CAD/CAM, three-unit posterior bridges, zirconia framework
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM VeneeringDevice
CAD/CAM fabricated zirconia bridge framework is veneered with CAD/CAM fabricated lithium disilicate ceramic veneer
Manually layered veneeringDevice
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM veneering | Experimental | CAD/CAM manufactured e.max CAD veneers on zirconia framework Receives: Device: CAD/CAM Veneering |
| manually layered | Active comparator | Manually layered veneering on CAD/CAM fabricated zirconia bridge framework Receives: Device: Manually layered veneering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinical success
Clinical success is defined as more than 95% survival of the restoration after 2 years.
Measured: 2 years
Secondary outcomes (1)
Restoration quality
Characterisation of the restorations according to United States Public Health Services (USPHS) criteria
Measured: 1 week, 1 year, 2 years, 3 years, 4 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJan 2010
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Three-unit Posterior BridgesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivoclar Vivadent AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Bindl, Dr.med.dent., Principal investigator, Universität Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175329
- Sponsor's protocol ID
- CAD-On
- Status last verified
- Mar 2017
- First submitted
- 23 Jun 2014
- Last updated
- 12 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of 3-unit Posterior Zirconia-ceramic Fixed Dental Prosthesis (FDPs) Veneered With Layered and Milled (CAD-on) Veneering Ceramics
- ClinicalTrials.gov ID
- NCT02175329
- Acronym / sponsor ID
- CAD-On
- Conditions
- Three-unit Posterior Bridges
- Keywords
- CAD/CAM, three-unit posterior bridges, zirconia framework
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 26 Jun 2014 (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.
60 bridge frameworks are CAD/CAM manufactured from zirconia-ceramic; 30 bridges are veneered with CAD/CAM fabricated lithium disilicate ceramic, 30 bridges are manually layered. The goal is to compare clinical survival , biological or technical behaviour of the restorations.
Detailed description
Randomized prospective controlled clinical study with three-unit posterior bridges made of zirconia-ceramic to compare veneering with manually layering or CAD/CAM fabricated lithium disilicate ceramic veneers. The hypothesis is that there is no difference in clinical survival of the restorations and no difference in biological or technical behaviour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM veneering | Experimental | Device: CAD/CAM VeneeringCAD/CAM manufactured e.max CAD veneers on zirconia framework |
| manually layered | Active comparator | Device: Manually layered veneeringManually layered veneering on CAD/CAM fabricated zirconia bridge framework |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- single missing posterior tooth with two adjacent posterior teeth
- no acute conservative or paradontal treatment need except for the teeth to be treated in the study
- sufficient oral hygiene
Key exclusion criteria (9 listed)
- known allergies to components
- bruxism
- missing antagonist tooth
- pregnancy or lactation
- missing written consent
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 |
|---|---|---|
| CAD/CAM VeneeringCAD/CAM fabricated zirconia bridge framework is veneered with CAD/CAM fabricated lithium disilicate ceramic veneer | Device | CAD/CAM veneering |
| Manually layered veneering | Device | manually layered |
Primary outcome
Number of participants with clinical success
Time frame: 2 years
Clinical success is defined as more than 95% survival of the restoration after 2 years.
1 secondary outcome
Restoration quality
Time frame: 1 week, 1 year, 2 years, 3 years, 4 years, 5 years
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 12 Feb 2020.
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.
Andreas Bindl, Dr.med.dent. principal investigator
Universität Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD/CAM Veneering and Manually layered veneering in people with Three-unit Posterior Bridges, run by Ivoclar Vivadent AG at 1 site in Switzerland.
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 9 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 12 Feb 2020. 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 Switzerland. 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?
Number of participants with clinical success (time frame: 2 years). 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 12 Feb 2020.