Clinical Trial: Clinical Study on Zirconia Bridges
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title:
Brief Summary: To evaluate the clinical performance and survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region for a period of 5 years. The working hypothesis of this clinical study is that 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 (80% R+S) and a sufficient survival rate (93%) after 5 years in comparison with a reference level of 95%.
Detailed Summary:
Sponsor: University of Siena
Current Primary Outcome: survival rate of NobelProcera™ Bridge Shaded Zirconia [ Time Frame: 5 years ]
Success and Failure Criteria The CDA index will be used for the success criteria in this investigation. Please see also the criteria in the "clinical parameter" part of this protocol.
The success and failure criteria to be used in this investigation have been determined as follows:
A successful NobelProcera™ Bridge Shaded Zirconia is when:
the CDA index is Romeo or Sierra at delivery and remains so during the study period.
A surviving NobelProcera™ Bridge Shaded Zirconia is when:
the restoration is in occlusion and in function, even though all the success criteria are not fulfilled, but is to be regarded as correctable.
A failed NobelProcera™ Bridge Shaded Zirconia is when:
the restoration has 1) been removed, 2) fractured, or 3) cannot be classified as a surviving or a successful restoration.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Siena
Dates:
Date Received: April 5, 2013
Date Started: January 2010
Date Completion: December 2015
Last Updated: July 4, 2014
Last Verified: July 2014
