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NobelProceraTM Bridge Shaded Zirconia

A Clinical Evaluation of NobelProceraTM Bridge Shaded Zirconia

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02197312
Enrollment
25
Registered
2014-07-22
Start date
2010-06-18
Completion date
2013-11-23
Last updated
2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Bridge Restoration

Keywords

yttrium-oxide, Y-TZP, bridge, NobelProcera, Shaded Zirconia

Brief 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

Interventions

DEVICENobelProcera Bridge Shaded Zirconia

Sponsors

Nobel Biocare
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

* 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

Design outcomes

Primary

MeasureTime frame
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)yearly up to 5 years

Secondary

MeasureTime frame
survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior regionyearly up to 5 years

Other

MeasureTime frame
esthetic performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region as determined by overall patient satisfaction surveyyearly up to 5 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026