Dental Prosthesis FailureNCT06713577
Clinical Study of a 3D Shaded Zirconia for Chairside CAD/CAM Restorations
An observational study of Dental Prosthesis Failure and Dental Prosthesis Complication, run by Dentsply Sirona Implants and Consumables at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Prosthesis Failure, Dental Prosthesis Complication
- What is being tested?
- CEREC Cercon 4D
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2024to 22 Nov 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Cariology, Restorative Sciences, and Endodontics at School of Dentistry
Ann Arbor, Michigan, 48109-1078
About this study
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.
Read the 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.
- Being tested
- CEREC Cercon 4D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEREC Cercon 4DDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Crowns | 35 crowns delivered with a universal resin cement (Calibra Universal + by Dentsply Sirona). Receives: Device: CEREC Cercon 4D | |
| 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). Receives: Device: CEREC Cercon 4D | |
| Group 3 Fixed Partial Dentures (FPD) | 12 Fixed Partial Dentures (FPD) delivered with a universal resin cement (Calibra Universal + by Dentsply Sirona). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the five year follow up
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: Once a week after base line up to four weeks or until patient is asymptomatic.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start3 Dec 2024
- Primary completion22 Jan 2031 (estimated)
- Study completion22 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Prosthesis FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis J Fasbinder, Principal investigator, Clinical Professor of Dentistry, Department of Cardiology, Restorative Sciences, and Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713577
- Sponsor's protocol ID
- C-RE-24-018
- Other IDs
- HUM00263115
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of a 3D Shaded Zirconia for Chairside CAD/CAM Restorations
- ClinicalTrials.gov ID
- NCT06713577
- Acronym / sponsor ID
- C-RE-24-018
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 22 Jan 2031 (estimated)
- Study completion
- 22 Nov 2031 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Crowns | – | Device: CEREC Cercon 4D35 crowns delivered with a universal resin cement (Calibra Universal + by Dentsply Sirona). |
| Group 2 Onlays | – | Device: CEREC Cercon 4D35 onlays delivered with selective enamel etch, bonding agent, and universal resin cement (Prime \& Bond Active with Calibra Universal + by Dentsply Sirona). |
| Group 3 Fixed Partial Dentures (FPD) | – | –12 Fixed Partial Dentures (FPD) delivered with a universal resin cement (Calibra Universal + by Dentsply Sirona). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEREC Cercon 4DOne 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. | Device | Group 1 Crowns, Group 2 Onlays |
Primary outcome
Evaluation of the longitudinal clinical performance of 3D shaded zirconia onlays, crowns and FPDs.
Time frame: At the five year follow up
The restorations will be evaluated according to the modified World Dental Federation notation (FDI) criteria for maintaining their esthetic functional and biological properties.
3 secondary outcomes
Evaluation of the longitudinal clinical performance of 3D shaded zirconia onlays, crowns and FPDs.
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.
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.
Time frame: Once a week after base line up to four weeks or until patient is asymptomatic.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis J Fasbinder principal investigator
Clinical Professor of Dentistry, Department of Cardiology, Restorative Sciences, and Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Prosthesis Failure and Dental Prosthesis Complication, run by Dentsply Sirona Implants and Consumables at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the longitudinal clinical performance of 3D shaded zirconia onlays, crowns and FPDs. (time frame: At the five year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.