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ClinicalTrials.gov Identifier: NCT02197312
Recruitment Status :
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
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 Outcome Measures :
survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region [ Time Frame: yearly up to 5 years ]
Other Outcome Measures:
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 ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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