Clinical Study of Porcelain-fused and IPS e.Max CAD Crowns
|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: NCT01835821|
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|
|Success Survival CDA Index||Device: prosthetic crowns||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Evaluation of Hand-veneered, Porcelain-fused NobelProcera(TM) Crown Shaded Zirconia and NobelProcera(TM) Full Contour Crown IPS e.Max CAD on Molars|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||March 2016|
NobelProcera™ Crown shaded zirconia:
The device is an individual, ceramic core (figure a) made of shaded zirconium with an anatomic contour providing homogenous veneering material thickness and a minimum core thickness of 0.4 or 0.7mm. The core is veneered with dental porcelain (IPS e.max Ceram) at the dental laboratory
Device: prosthetic crowns
- success of Porcelain-fused and IPS e.Max CAD Crowns [ Time Frame: 5 years ]A "successful crown" is when the CDA index (Marginal integrity, Color match, Surface texture and Anatomic form) shall be Romeo or Sierra (excellent or acceptable) at delivery and remain so during the study period.
- survival of Porcelain-fused and IPS e.Max CAD Crowns [ Time Frame: 5 years ]A "surviving crown" is when the crown remains in occlusion, and when the subject's treatment is functionally successful even though all the individual success criteria are not fulfilled.
- CDA index [ Time Frame: 5 years ]California Dental Association. Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835821
|Department of Dental Materials and Fixed Prosthodontics of Siena, Tuscan School of Dental Medicine, University of Florence and Siena, Siena, Italy|
|Siena, SI, Italy, 53100|