NCT06713577

Clinical Study of a 3D Shaded Zirconia for Chairside CAD/CAM Restorations

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 82 (estimated)
• Sponsor: Dentsply Sirona Implants and Consumables · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Dental Prosthesis Failure
• Dental Prosthesis Complication

Interventions

Type	Name	Description
DEVICE	CEREC Cercon 4D	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.

Timeline

• Start date: 2024-12-03
• Primary completion: 2031-01-22
• Completion: 2031-11-22
• First posted: 2024-12-03
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study