Clinical Study of Porcelain-fused and IPS e.Max CAD Crowns
This clinical study has the objective to compare the longevity and the clinical behaviour (CDA Index, soft tissue behavior, success and survival rates) of single cemented ceramic crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full contour crowns IPS e.max CAD lithium disilicate on molars.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- success of Porcelain-fused and IPS e.Max CAD Crowns [ Time Frame: 5 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]California Dental Association. Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|