MedTrace Logo

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

NCT06713577 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 82

Last updated 2026-03-09

No results posted yet for this study

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.

Conditions

  • Dental Prosthesis Failure
  • Dental Prosthesis Complication

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.

Sponsors & Collaborators

  • Dentsply Sirona Implants and Consumables

    lead INDUSTRY

Principal Investigators

  • Dennis J Fasbinder · Clinical Professor of Dentistry, Department of Cardiology, Restorative Sciences, and Endodontics

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-03
Primary Completion
2031-01-22
Completion
2031-11-22
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06713577 on ClinicalTrials.gov