Fractured ToothNCT04604301
Celtra Quatro Crown Study
A study testing Celtra Quatro in people with Fractured Tooth and Decayed Tooth, run by University of Michigan at 1 site in United States.
Trial summary
This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Fractured Tooth, Decayed Tooth, Unsatisfactory Restoration of Tooth
- What is being tested?
- Celtra Quatro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2020to 1 Nov 2027
- Phase
- Interventional
- 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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
- reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
- Teeth to be vital and asymptomatic prior to 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.
Who cannot join
- Devital or sensitive teeth
- Teeth with prior endodontic treatment of any kind
- Teeth with a history of direct or indirect pulp capping procedures
- Patients with significant untreated dental disease to include periodontitis and rampant caries
- Pregnant or lactating women
- Patients with a history of allergies to any of the materials to be used in the study
- Patients unable to return for the recall appointments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of High Strength Zirconia-Reinforced Lithium Silicate Chairside CAD/CAM Crowns
This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.
Read the detailed description
A recently introduced high strength, zirconia-reinforced lithium silicate (ZLS) ceramic material for full contour CAD/CAM crowns is reported to offer a more translucent and esthetic high strength crown in a more efficient oven firing process. Celtra Quatro (Dentsply Sirona) is submitted to a high temperature matrix firing cycle in the SpeedFire oven (Dentsply Sirona) to achieve high strength in less than 5 minutes following milling. It has a reported flexural strength of 650 MPa compared to 450 MPa for lithium disilicate glass ceramic and > 900 MPa for 3mol% full contour zirconia.
Most glass ceramic materials have a recommended material thickness of 1.5 mm to maximize the strength potential of the material. Occlusal reduction resulting in a crown thickness of 1.0 mm, equitable to the recommendation for full contour zirconia crowns, may be considered sufficient to maintain the desired high strength attained by the ZLS material. This would also result in a more conservative tooth preparation.
Another potential advantage of high strength ZLS crowns to many clinicians is that they may be inherently strong enough to allow for conventional cementation. However, for less retentive preparations, it may also be possible to adhesively bond the crowns through the use of adhesive resin cements.
It is the intent of this investigation to evaluate the clinical application and performance of the new high strength, zirconia-reinforced lithium silicate material (Celtra Quatro) for CAD/CAM-generated chair-side crown applications. Patients will be recruited to have 60 Celtra Quatro crowns prepared and delivered during a single dental appointment using a chairside CAD/CAM system (CEREC/Dentsply Sirona). The crowns will be recalled at 6 months and then yearly for 5 years to evaluate long-term outcomes of the crowns.
- Being tested
- Celtra Quatro
- Keywords
- Crown, Ceramic, CAD/CAM
- Medical subject headings
- Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celtra QuatroDevice
Full ceramic crowns will be made from the high strength ceramic, Celtra Quatro
| Study group | Role | What they receive |
|---|---|---|
| Crown, 1.0mm thickness, Calcium Aluminate Ionomer Cement | Experimental | occlusal thickness of 1.0 mm delivered with a conventional Calcium Aluminate Ionomer cement Receives: Device: Celtra Quatro |
| Crown, 1.5mm thickness, Calcium Aluminate Ionomer Cement | Experimental | occlusal thickness of 1.5 mm delivered with a conventional Calcium Aluminate Ionomer cement Receives: Device: Celtra Quatro |
| Crown, 1.0mm thickness, dual cure resin cement | Experimental | occlusal thickness of 1.0 mm delivered with Prime and Bond elect Universal Bond in total etch mode with a dual cure resin cement Receives: Device: Celtra Quatro |
| Crown, 1.5mm thickness, dual cure resin cement | Experimental | occlusal thickness of 1.5 mm delivered with Prime and Bond elect Universal Bond in total etch mode with a dual cure resin cement Receives: Device: Celtra Quatro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crown failure
Restoration failure is scored by visual loss of the crown from the tooth requiring replacement of the study crown with a new crown at any time between delivery and five years.
Measured: from delivery of the crown up to 5 years
Secondary outcomes (3)
Crown loss of retention
Loss of retention is measured as visual detachment or dislodgment of the crown from the tooth without fracture of the crown requiring recementation of the crown at any time between delivery and five years.
Measured: from delivery of crown up to 5 years
Tooth sensitivity
Patient described sensitivity on a scale of 1 to 4, where 1 means absence of sensitivity (pain) and four means severe discomfort noted routinely with cold or pressure stimulation.
Measured: from delivery of crown up to 5 years
Margin staining
Margin staining is categorized based on modified US Public Health Service criteria using a four point scale where 1 is no staining and 4 is penetrating stain involving more than 50% of the margin.
Measured: from delivery of crown up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start24 Sep 2020
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractured ToothStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Principal investigator, Dennis J. Fasbinder, DDS, University of Michigan
- Investigators
- Dennis Fasbinder, DDS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604301
- Sponsor's protocol ID
- HUM00155462
- Status last verified
- Mar 2026
- First submitted
- 22 Oct 2020
- Last updated
- 19 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of High Strength Zirconia-Reinforced Lithium Silicate Chairside CAD/CAM Crowns
- ClinicalTrials.gov ID
- NCT04604301
- Acronym / sponsor ID
- HUM00155462
- Keywords
- Crown, Ceramic, CAD/CAM
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 27 Oct 2020 (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 clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.
Detailed description
A recently introduced high strength, zirconia-reinforced lithium silicate (ZLS) ceramic material for full contour CAD/CAM crowns is reported to offer a more translucent and esthetic high strength crown in a more efficient oven firing process. Celtra Quatro (Dentsply Sirona) is submitted to a high temperature matrix firing cycle in the SpeedFire oven (Dentsply Sirona) to achieve high strength in less than 5 minutes following milling. It has a reported flexural strength of 650 MPa compared to 450 MPa for lithium disilicate glass ceramic and > 900 MPa for 3mol% full contour zirconia.
Most glass ceramic materials have a recommended material thickness of 1.5 mm to maximize the strength potential of the material. Occlusal reduction resulting in a crown thickness of 1.0 mm, equitable to the recommendation for full contour zirconia crowns, may be considered sufficient to maintain the desired high strength attained by the ZLS material. This would also result in a more conservative tooth preparation.
Another potential advantage of high strength ZLS crowns to many clinicians is that they may be inherently strong enough to allow for conventional cementation. However, for less retentive preparations, it may also be possible to adhesively bond the crowns through the use of adhesive resin cements.
It is the intent of this investigation to evaluate the clinical application and performance of the new high strength, zirconia-reinforced lithium silicate material (Celtra Quatro) for CAD/CAM-generated chair-side crown applications. Patients will be recruited to have 60 Celtra Quatro crowns prepared and delivered during a single dental appointment using a chairside CAD/CAM system (CEREC/Dentsply Sirona). The crowns will be recalled at 6 months and then yearly for 5 years to evaluate long-term outcomes of the crowns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Crown, 1.0mm thickness, Calcium Aluminate Ionomer Cement | Experimental | Device: Celtra Quatroocclusal thickness of 1.0 mm delivered with a conventional Calcium Aluminate Ionomer cement |
| Crown, 1.5mm thickness, Calcium Aluminate Ionomer Cement | Experimental | Device: Celtra Quatroocclusal thickness of 1.5 mm delivered with a conventional Calcium Aluminate Ionomer cement |
| Crown, 1.0mm thickness, dual cure resin cement | Experimental | Device: Celtra Quatroocclusal thickness of 1.0 mm delivered with Prime and Bond elect Universal Bond in total etch mode with a dual cure resin cement |
| Crown, 1.5mm thickness, dual cure resin cement | Experimental | Device: Celtra Quatroocclusal thickness of 1.5 mm delivered with Prime and Bond elect Universal Bond in total etch mode with a dual cure resin cement |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
- reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
- Teeth to be vital and asymptomatic prior to 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.
Key exclusion criteria (7 listed)
- Devital or sensitive teeth
- Teeth with prior endodontic treatment of any kind
- Teeth with a history of direct or indirect pulp capping procedures
- Patients with significant untreated dental disease to include periodontitis and rampant caries
- Pregnant or lactating women
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 |
|---|---|---|
| Celtra QuatroFull ceramic crowns will be made from the high strength ceramic, Celtra Quatro | Device | Crown, 1.0mm thickness, Calcium Aluminate Ionomer Cement, Crown, 1.0mm thickness, dual cure resin cement, Crown, 1.5mm thickness, Calcium Aluminate Ionomer Cement, Crown, 1.5mm thickness, dual cure resin cement |
Primary outcome
Crown failure
Time frame: from delivery of the crown up to 5 years
Restoration failure is scored by visual loss of the crown from the tooth requiring replacement of the study crown with a new crown at any time between delivery and five years.
3 secondary outcomes
Crown loss of retention
Time frame: from delivery of crown up to 5 years
Tooth sensitivity
Time frame: from delivery of crown up to 5 years
Margin staining
Time frame: from delivery of crown up to 5 years
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 19 Mar 2026.
- Individual participant dataSharing planned: No
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 Fasbinder, DDS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celtra Quatro in people with Fractured Tooth and Decayed Tooth, run by University of Michigan 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 7 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 19 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?
Crown failure (time frame: from delivery of the crown up to 5 years). 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 19 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.