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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Prosthesis Failure; Dental Prosthesis Complication
• Intervention / Treatment: Device: CEREC Cercon 4D

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.

• Study Type: Observational
• Enrollment (Estimated): 82

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-1078
      • Department of Cariology, Restorative Sciences, and Endodontics at School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The patient population will be selected from current patients of either gender and any ethnic background, under clinical treatment at the University of Michigan Dental Clinics.

Description

Inclusion Criteria:

• Adult aged 18-75 years.
• Willing and able to sign and date the informed consent form and the HIPAA form.
• Onlays and Crowns: Each patient should have at least one carious lesion, defective restoration, or fractured portion of the tooth to be restored on a maxillary or mandibular premolar or molar tooth. Each lesion, fracture, or defective restoration should exhibit sufficient size or loss of tooth structure requiring an onlay or crown restoration. The tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact. No more than eight teeth that are endodontically treated and restorable with an onlay or crown may be included in the study. All remaining teeth in the study will test vital and be asymptomatic at the beginning of treatment. No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.
• Fixed Partial Dentures (FPDs): Each patient should have at least one missing tooth, either anterior or posterior, that is appropriate for replacement with a fixed partial denture. Abutment teeth will have healthy periodontal status with at least a 1:1 crown:root ratio. The FPD should have at least two opposing teeth in occlusion and one adjacent tooth with an intact proximal contact. Both abutment teeth must be asymptomatic prior to treatment. Endodontically treated teeth will be acceptable for abutments if nonmetallic cores can be placed to retain the FPD. FPDs may include 3 or 4 teeth as indicated by the clinical situation but must be within the 43 mm span of the mill block to manufacture it as described later. The patient cohort should include a mix of non-endodontically as well as endodontically treated teeth.

Exclusion Criteria:

• Unlikely to be able to comply with clinical study procedures, according to Principal Investigator's (PIs) judgment.
• Subject is not willing to participate in the clinical study.
• Patients unable to return for the recall appointments for a period of 5 years.
• Severe non-compliance to the clinical study plan as judged by the PI and/or Dentsply Sirona.
• Involvement in the planning and conduct of the clinical study. Applies to both Dentsply Sirona personnel and personnel from the clinical study site.
• Sensitive teeth.
• Teeth diagnosed with symptoms of incomplete tooth fracture.
• Teeth with a history of direct or indirect pulp capping procedures.
• Patients with significant untreated dental disease to include periodontitis and/or rampant caries.
• Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times.
• Patients with a self-reported history of allergies to the materials to be used in the study including composite resin cements, provisional acrylics, or zirconia restorative materials.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 Crowns; 35 crowns delivered with a universal resin cement (Calibra Universal + by Dentsply Sirona).	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.
Group 2 Onlays; 35 onlays delivered with selective enamel etch, bonding agent, and universal resin cement (Prime & Bond Active with Calibra Universal + by Dentsply Sirona).	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.
Group 3 Fixed Partial Dentures (FPD); 12 Fixed Partial Dentures (FPD) delivered with a universal resin cement (Calibra Universal + by Dentsply Sirona).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the five year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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: = No sensitivity is experienced at anytime; = Slight sensitivity is experienced occasionally but it is not uncomfortable; = Moderate sensitivity is experienced intermittently, and it is noticeably uncomfortable; = Severe discomfort is noted routinely with cold or pressure stimulation	Once a week after base line up to four weeks or until patient is asymptomatic.

Collaborators and Investigators

• Sponsor: Dentsply Sirona Implants and Consumables
• Investigators: Principal Investigator: Dennis J Fasbinder, Clinical Professor of Dentistry, Department of Cardiology, Restorative Sciences, and Endodontics

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): January 22, 2031
• Study Completion (Estimated): November 22, 2031

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Prosthesis Failure
• Other Study ID Numbers: C-RE-24-018; HUM00263115 (Other Identifier: Medical School Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No