This investigation will be a prospective, longitudinal clinical trial to study the clinical performance of a new monolithic, 3D shaded zirconia material for computer assisted design and computer assisted machining for chairside restorations. The restorations will be evaluated for a period of up to five years. The study is called Clinical Study of a 3D Shaded Zirconia for chairside computer assisted design and computer assisted machining (CAD/CAM) chairside restorations intended to be part of the validation plan and post market follow-up of the following products: CEREC Cercon 4D, Calibra Universal +, and Prime and Bond Active.
The primary aim is: ▪ Evaluate the longitudinal clinical performance of 3D shaded zirconia onlays, crowns, and fixed partial denture (FPD) over five years of clinical service. The restorations will be evaluated with modified FDI criteria for maintaining their esthetic, functional and biological properties. The secondary aims are: * Evaluate the resistance to material chipping and fracture of reduced thickness zirconia chairside computer assisted design and computer assisted machining (CAD/CAM) onlays, crowns, and fixed partial dentures (FPDs). * Evaluate the short-term post-operative sensitivity associated with cementation techniques using a self-adhesive, universal resin cement and a selective etch/universal bonding agent with a universal resin cement.
Study Type
OBSERVATIONAL
Enrollment
82
One investigational medical device is a new generation of a full contour zirconia restorative material (CEREC Cercon 4D/Dentsply Sirona) for chairside computer assisted design/computer assisted machines (CAD/CAM) restorations. It has an internal core of 4 mol% (4Y) zirconia transitioning to an external layer of 4/5 mol% (4/5 Y) zirconia with a three-dimensional gradient of shade from an inner chromatic layer to an external translucent layer that replicates the natural structure and appearance of a tooth. It is indicated for crowns, bridges, veneers, inlays and onlays and implant crowns Clinical Study of a 3D Shaded Zirconia for Chairside CAD/CAM Restorations The other investigational medical devices are a universal bonding agent (Prime and Bond Active/Dentsply Sirona) and dual-cure, self-adhesive resin cement (Calibra Universal +/Dentsply Sirona). They are used in combination to deliver ceramic and zirconia restorations.
Department of Cariology, Restorative Sciences, and Endodontics at School of Dentistry
Ann Arbor, Michigan, United States
Evaluation of the longitudinal clinical performance of 3D shaded zirconia onlays, crowns and FPDs.
The restorations will be evaluated according to the modified World Dental Federation notation (FDI) criteria for maintaining their esthetic functional and biological properties.
Time frame: At the five year follow up
Evaluation of the longitudinal clinical performance of 3D shaded zirconia onlays, crowns and FPDs.
The restorations will be evaluated according to the modified World Dental Federation notation criteria (FDI) for maintaining their esthetic functional and biological properties.
Time frame: At the 6 month, 1 year, 2 year, 3 year and 4 year follow up
Evaluation of the resistance of the material chipping and fracture of the reduce thickness zirconia CAD/CAM onlays, crowns and FPDs.
The restorations will be evaluated according to the modified World Dental Federation notation (FDI) criteria for maintaining their esthetic functional and biological properties.
Time frame: At the 6 month, 1 year, 2 year, 3 year and 4 year and 5 year follow up.
Evaluation of the short-term post operative sensitivity associated with cementation techniques using a self-adhesive, universal resin cement and a selective etch/universal bonding agent with a universal resin cement.
A criterion-referenced rating scale will be used to measure sensitivity (Scores 1-4) Sensitivity: 1. = No sensitivity is experienced at anytime 2. = Slight sensitivity is experienced occasionally but it is not uncomfortable 3. = Moderate sensitivity is experienced intermittently, and it is noticeably uncomfortable 4. = Severe discomfort is noted routinely with cold or pressure stimulation
Time frame: Once a week after base line up to four weeks or until patient is asymptomatic.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.