Posterior Bridge RestorationNCT02197312
NobelProceraTM Bridge Shaded Zirconia
A study testing NobelProcera Bridge Shaded Zirconia in people with Posterior Bridge Restoration, run by Nobel Biocare at 1 site in Germany.
Trial summary
Industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings and a sufficient survival rate after 5 years Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Posterior Bridge Restoration
- What is being tested?
- NobelProcera Bridge Shaded Zirconia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jun 2010to 23 Nov 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion.
- The subject is healthy and compliant with good oral hygiene
- The subject is in need of a posterior fixed partial denture restoration 3 or 4 units distal of the canines in the maxilla or mandible.
- The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
- Obtained informed consent from the subject prior to the study.
- No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
- Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
- The subject should be available for the 5-year term of the investigation.
Who cannot join
- The subject is not able to give her/his informed consent to participate.
- Alcohol or drug abuse as noted in patient records or in patient history.
- Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.
- An existing condition where acceptable retention of the restoration is impossible to attain
- Mobility greater than grade 1 of the tooth to be restored.
- Pathologic pocket formation of 4 mm or greater around the tooth to be restored
Show all 9Show fewer
- Severe bruxism or other destructive habits
- Amount of attached soft tissue is insufficient (attached gingiva less than 2 mm or attachment loss greater than half of the root length).
- Health conditions, which do not permit the restorative procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Evaluation of NobelProceraTM Bridge Shaded Zirconia
Industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings and a sufficient survival rate after 5 years
- Conditions
- Posterior Bridge Restoration
- Being tested
- NobelProcera Bridge Shaded Zirconia
- Keywords
- yttrium-oxide, Y-TZP, bridge, NobelProcera, Shaded Zirconia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NobelProcera Bridge Shaded ZirconiaDevice
| Study group | Role | What they receive |
|---|---|---|
| NobelProcera Bridge Shaded Zirconia | Other | posterior region Receives: Device: NobelProcera Bridge Shaded Zirconia |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region with the proportion of patients with CDA ratings "R" (excellent) or "S"(acceptable)
Measured: yearly up to 5 years
Secondary outcomes (1)
survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region
Measured: yearly up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study start18 Jun 2010
- Primary completion23 Nov 2013
- Study completion23 Nov 2013
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Bridge RestorationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobel Biocare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197312
- Sponsor's protocol ID
- T-159
- Status last verified
- Mar 2017
- First submitted
- 3 Jul 2014
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of NobelProceraTM Bridge Shaded Zirconia
- ClinicalTrials.gov ID
- NCT02197312
- Acronym / sponsor ID
- T-159
- Conditions
- Posterior Bridge Restoration
- Keywords
- yttrium-oxide, Y-TZP, bridge, NobelProcera, Shaded Zirconia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nobel BiocareIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2010 (actual)
- Primary completion
- 23 Nov 2013 (actual)
- Study completion
- 23 Nov 2013 (actual)
- First posted
- 22 Jul 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.
Industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings and a sufficient survival rate after 5 years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NobelProcera Bridge Shaded Zirconia | Other | Device: NobelProcera Bridge Shaded Zirconiaposterior region |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion.
- The subject is healthy and compliant with good oral hygiene
- The subject is in need of a posterior fixed partial denture restoration 3 or 4 units distal of the canines in the maxilla or mandible.
- The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
- Obtained informed consent from the subject prior to the study.
Key exclusion criteria (9 listed)
- The subject is not able to give her/his informed consent to participate.
- Alcohol or drug abuse as noted in patient records or in patient history.
- Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.
- An existing condition where acceptable retention of the restoration is impossible to attain
- Mobility greater than grade 1 of the tooth to be restored.
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 |
|---|---|---|
| NobelProcera Bridge Shaded Zirconia | Device | NobelProcera Bridge Shaded Zirconia |
Primary outcome
clinical performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region with the proportion of patients with CDA ratings "R" (excellent) or "S"(acceptable)
Time frame: yearly up to 5 years
1 secondary outcome
survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region
Time frame: yearly up to 5 years
Results and safety
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
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?
A study testing NobelProcera Bridge Shaded Zirconia in people with Posterior Bridge Restoration, run by Nobel Biocare 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 8 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: stopped early, as of the sponsor's last update on 30 Mar 2017. 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 was stopped early (reason given: Business reasons). 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?
clinical performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region with the proportion of patients with CDA ratings "R" (excellent) or "S"(acceptable) (time frame: yearly up to 5 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 30 Mar 2017.