CClinicalTrials.gg
TerminatedNCT02197312Updated Mar 30, 2017

NobelProceraTM Bridge Shaded Zirconia

An interventional study of NobelProcera Bridge Shaded Zirconia in Posterior Bridge Restoration, sponsored by Nobel Biocare. Terminated at 1 site in Germany. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-30.

Sponsored by Nobel Biocare · Not applicable, Interventional, and Treatment

Why this study was terminated
Business reasons

From the registry’s dates

  • Registered 4 years after the study started (first participant enrolled Jun 2010, registered Jul 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Posterior Bridge Restoration

Keywords

  • yttrium-oxide
  • Y-TZP
  • bridge
  • NobelProcera
  • Shaded Zirconia
03

In context

Lead sponsor

Nobel Biocare is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Other
    NobelProcera Bridge Shaded Zirconia

    posterior region

    Device: NobelProcera Bridge Shaded Zirconia

Interventions

  • DeviceNobelProcera Bridge Shaded Zirconia
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region

    Time frame: yearly up to 5 years

Other outcomes

  1. esthetic performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region as determined by overall patient satisfaction survey

    Time frame: yearly up to 5 years

07

Study locations

1 site
  • Universitätsklinikum Aachen
    Aachen, 52074, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02197312
Lead sponsor
Nobel Biocare
Responsible party
Sponsor
First posted
Jul 22, 2014
Start date
Jun 18, 2010
Primary completion
Nov 23, 2013
Completion
Nov 23, 2013
Last update
Mar 30, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion