Partial EdentulismNCT02186808

T-116_Procera-Bridge Zirconia - A Clinical Study

A study testing Procera® Bridge Zirconia in people with Partial Edentulism, run by Nobel Biocare.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of the study is to evaluate the clinical performance of Procera® Bridge Zirconia veneered with NobelRondo Zirconia. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Partial Edentulism
What is being tested?: Procera® Bridge Zirconia
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: May 2005to Apr 2015
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 planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible
Indication: same indication as for metal supported bridges
Obtained informed consent from the patient

Who cannot join

Currently known alcohol, drug or medication abuse, judged by the investigator, which might influence the follow-up program
Patients where a bridge part connection area of 3 mm of diameter is not possible to obtain (short clinical crowns)
Mobility of the abutment teeth exceeding grade I
Patients with pathologic pocket formation at abutment teeth
Patients with complete dentures in the opposing jaw
Patients with a removable partial denture in the same jaw

About this study

Official title: Procera-Bridge Zirconia - A Clinical Study

The objective of the study is to evaluate the clinical performance of Procera® Bridge Zirconia veneered with NobelRondo Zirconia.

Read the detailed description

The study was designed to be an open, 5-year, prospective, multi-center clinical post-market study. The objectives of this clinical study were that industrial centrally produced 3- or 4-unit bridges of yttrium-oxide partially-stabilized (Y-TZP) zirconia (Procera Zirconia) in combination with the veneering ceramic material NobelRondo will show sufficient CDA ratings (90% R+S) and a sufficient survival rate after 1 and 5 years.

Conditions: Partial Edentulism
Being tested: Procera® Bridge Zirconia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Procera® Bridge ZirconiaDevice
Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.

Study groups in NCT02186808
Study group	Role	What they receive
Procera® Bridge Zirconia	Other	Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. Receives: Device: Procera® Bridge Zirconia

What is being measured

The primary outcome is the main question the study is designed to answer.

Success Rate of Bridge Procera Bridge Zirconia
The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.
Measured: prosthesis delivery, 1 year

Secondary outcomes (1)

Success Rate of Bridge Procera Bridge Zirconia
The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading.
Measured: prosthesis delivery, 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2005Apr 2015

First posted10 Jul 2014 (estimated)
Study startMay 2005
Primary completionApr 2015
Study completionApr 2015

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 Partial EdentulismStudies 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: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02186808
Sponsor's protocol ID: T-116
Status last verified: Sep 2016
First submitted: 27 Jun 2014
Last updated: 27 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Association, C.D., Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Not yet recruiting
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Active, not recruiting
Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
Partial Edentulism Class 3, Removable Partial Denture
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants

All Partial Edentulism trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Procera-Bridge Zirconia - A Clinical Study
ClinicalTrials.gov ID: NCT02186808
Acronym / sponsor ID: T-116
Conditions: Partial Edentulism
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Nobel BiocareIndustry (pharma, biotech, devices)
Study start: May 2005
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 10 Jul 2014 (estimated)
Results: Posted 25 Apr 2016

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 the study is to evaluate the clinical performance of Procera® Bridge Zirconia veneered with NobelRondo Zirconia.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Procera® Bridge Zirconia	Other	Device: Procera® Bridge ZirconiaPatients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible
Indication: same indication as for metal supported bridges
Obtained informed consent from the patient

Key exclusion criteria (6 listed)

Currently known alcohol, drug or medication abuse, judged by the investigator, which might influence the follow-up program
Patients where a bridge part connection area of 3 mm of diameter is not possible to obtain (short clinical crowns)
Mobility of the abutment teeth exceeding grade I
Patients with pathologic pocket formation at abutment teeth
Patients with complete dentures in the opposing jaw

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
Procera® Bridge ZirconiaPatients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.	Device	Procera® Bridge Zirconia

Primary outcome

Success Rate of Bridge Procera Bridge Zirconia
Time frame: prosthesis delivery, 1 year
The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.

1 secondary outcome

Success Rate of Bridge Procera Bridge Zirconia
Time frame: prosthesis delivery, 5 years

Results and safety

Results posted to the registry on 25 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Procera® Bridge Zirconia	80	67

Primary outcome: Success Rate of Bridge Procera Bridge Zirconia

Time frame: prosthesis delivery, 1 year. Number. Unit: percentage of successful implants

Measure	Procera® Bridge Zirconia n = 78
Value	100

Procera® Bridge Zirconia: p <0.05, Wilcoxon (Mann-Whitney)

Population analysed: 78 patients were treated in total. 4 of the patients received two bridges (which is complaint with the protocol). Therefore there are more bridges than patients.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Procera® Bridge Zirconia	3 of 80 (3.8%)	38 of 80 (47.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundAssociation, C.D., Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977.
Individual participant dataSharing planned: No

Related trials for Partial Edentulism

Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Not yet recruiting
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Active, not recruiting
Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
Partial Edentulism Class 3, Removable Partial Denture
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants

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 Procera® Bridge Zirconia in people with Partial Edentulism, run by Nobel Biocare.

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 6 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 27 Oct 2016. 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 25 Apr 2016). 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?

Success Rate of Bridge Procera Bridge Zirconia (time frame: prosthesis delivery, 1 year). 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 NCT02186808, 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 27 Oct 2016.