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ACTIVE NOT RECRUITING
NCT06713577

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

Sponsor: Dentsply Sirona Implants and Consumables

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

82

Start Date

2024-12-03

Completion Date

2031-11-22

Last Updated

2026-03-09

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Department of Cariology, Restorative Sciences, and Endodontics at School of Dentistry

Ann Arbor, Michigan, United States