An interventional study of zirconia bridge restoration in Missing Teeth, sponsored by University of Siena. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-07-08.
Sponsored by University of Siena · Not applicable, Interventional, and Treatment
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%.
224 studies on the registry are indexed under Tooth Loss; 50 are open to participants now.
This study's enrollment of 9 is below the median of 30 across 166 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →University of Siena is the lead sponsor of 65 studies on the registry; 15 are open to participants now.
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The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion.
Exclusion Criteria:
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
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.
Time frame: 5 years
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This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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University of Siena