Clinical Study on Zirconia Bridges
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01835834|
Recruitment Status : Unknown
Verified July 2014 by Prof. Marco Ferrari, University of Siena.
Recruitment status was: Active, not recruiting
First Posted : April 19, 2013
Last Update Posted : July 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Missing Teeth||Procedure: zirconia bridge restoration||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||December 2015|
Experimental: zirconia bridge restoration
The device is a ceramic core made of shaded zirconium with an anatomic contour core with a minimum of 0.6 mm** thickness and minimal connector size of 4.0 x 3.0 / 9.4 (height x width [mm] / area [mm2])** of high strength zirconia framework providing homogenous veneering material thickness as an external coating with 1.0 - 2.0 mm* wall thickness. The core is veneered with dental porcelain at the dental laboratory.
Intended use and indications:
NobelProceraTM Bridge Shaded Zirconia consists of an individualized, supporting substructure in a ceramic bridge construction for tooth/teeth replacement.
NobelProceraTM Bridge Zirconia is intended for patients in need of prosthetic oral reconstruction in order to restore chewing function. Zirconia bridges for natural tooth restorations are customized, designed, and milled from pre-sintered blanks of zirconia. The multi-unit restorations can be placed in all positions in the mouth.
Procedure: zirconia bridge restoration
- 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.