NobelProceraTM Bridge Shaded Zirconia

Study Overview
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Brief Summary
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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

Official Title
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A Clinical Evaluation of NobelProceraTM Bridge Shaded Zirconia

Conditions
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Posterior Bridge Restoration

Intervention / Treatment
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* Device: NobelProcera Bridge Shaded Zirconia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NobelProcera Bridge Shaded Zirconia<br>posterior region | Device: NobelProcera Bridge Shaded Zirconia<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region |  | yearly up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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yttrium-oxide, Y-TZP, bridge, NobelProcera, Shaded Zirconia