Endodontically Treated TeethNCT04604314
Alternative EndoCrowns Designs for Chairside CAD/CAM
A study testing CEREC Tessera in people with Endodontically Treated Teeth, run by University of Michigan at 1 site in United States.
Trial summary
This investigation will be a longitudinal clinical trial to study the association of preparation design on the internal and marginal adaptation of the resulting restorations and the long-term clinical performance of chairside CAD/CAM endocrown restorations. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- CEREC Tessera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2020to 8 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject in need of final restoration following molar endodontic therapy
- Subject age 18 or above -
Who cannot join
- Teeth with remaining symptoms following endodontic therapy
- Teeth which have experienced endodontic complications to include treated perforations, internal or external resorption, or separated endodontic files.
- Teeth with exposure of the root canal filling material to the oral environment for greater than two weeks
- Teeth diagnosed with symptoms of incomplete tooth fracture
- Teeth with no adjacent or opposing tooth
- Teeth serving as an abutment for fixed or removable dental prostheses
Show all 12Show fewer
- Subjects with uncontrolled bruxism or parafunctional habits
- Subject has known allergies to any product used in this study
- Subject will not be available for the study duration of 5 years
- Subjects with significant untreated dental disease to include periodontitis and rampant caries
- Women who self-report that they are pregnant or lactating
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Alternative Preparation Designs for Chairside CAD/CAM Fabricated Advanced Lithium Disilicate EndoCrowns
This investigation will be a longitudinal clinical trial to study the association of preparation design on the internal and marginal adaptation of the resulting restorations and the long-term clinical performance of chairside CAD/CAM endocrown restorations. Advanced lithium disilicate chairside CAD/CAM endocrowns (CEREC Tessera/Dentsply Sirona) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (Prime and Bond Elect/Dentsply Sirona) and a dual cure resin adhesive cement (Calibra Ceram/Dentsply Sirona). All restorations will be followed over five years of clinical service.
Read the detailed description
Endodontically treated teeth commonly present with extensive tooth structure loss due to caries, trauma, prior restorative treatment, and the endodontic access. These structural deficiencies lead to an increase in cusp deflection, crown fractures, microleakage, and decreased sensory feedback during function which greatly increases the possibility of tooth fracture.As a result, endodontically treated teeth require a full cuspal coverage restoration to prevent microleakage, restore function, and provide cuspal protection against tooth fracture. The most common restoration for endodontically treated teeth is core build-up, with or without a post, and full coverage crown.
This process requires multiple appointments with many technical steps ultimately leading to more chair time, treatment cost, and potential iatrogenic damage to the tooth. An alternative treatment is the endocrown, which utilizes the internal walls of the pulp chamber for macroretention and incorporates the core and crown in a monolithic restoration. The restoration is fabricated utilizing chairside CAD/CAM technology and is adhesively bonded to the tooth with resin cement. The EndoCrown restoration is more conservative relative to tooth structure loss, less expensive, and requires less chair time to complete when compared to conventional treatment while having comparable clinical longevity in molar teeth.
This investigation will be a longitudinal clinical trial to study the association of preparation design on the internal and marginal adaptation of the resulting restorations and the long-term clinical performance of chairside CAD/CAM endocrown restorations. Advanced lithium disilicate chairside CAD/CAM endocrowns (CEREC Tessera/Dentsply Sirona) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (Prime and Bond Elect/Dentsply Sirona) and a dual cure resin adhesive cement (Calibra Ceram/Dentsply Sirona). All restorations will be followed over five years of clinical service.
- Conditions
- Endodontically Treated Teeth
- Being tested
- CEREC Tessera
- Keywords
- Ceramic, Crown, Endocrown
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEREC TesseraDevice
Full ceramic endocrown restorations will be made from the high strength ceramic, CEREC Tessera
| Study group | Role | What they receive |
|---|---|---|
| Endocrown Onlay Restoration | Experimental | Endocrown onlay preparation = Buccal and lingual walls are intact with an occlusal-gingival height at least equal to half the original crown height of the tooth. Remaining buccal and lingual walls maintain a thickness ≥ 2.0 mm. Receives: Device: CEREC Tessera |
| Endocrown Shoulder Restorations | Experimental | Endocrown shoulder preparation = Buccal and/or lingual walls are less than half the original occlusal-gingival height of the tooth or the buccal or lingual surfaces were previously prepared axially due to a prior restoration. Receives: Device: CEREC Tessera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration 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 three years.
Measured: from delivery of the crown up to 3 years
Secondary outcomes (2)
Restoration 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.
Measured: from delivery of crown up to 3 years
Margin Staining
Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth, or "1" if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below.
Measured: from delivery of crown up to 3 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 start10 Dec 2020
- Primary completion8 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endodontically Treated TeethStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 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
- NCT04604314
- Sponsor's protocol ID
- HUM00172803
- Status last verified
- Jun 2026
- First submitted
- 22 Oct 2020
- Last updated
- 13 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Alternative Preparation Designs for Chairside CAD/CAM Fabricated Advanced Lithium Disilicate EndoCrowns
- ClinicalTrials.gov ID
- NCT04604314
- Acronym / sponsor ID
- HUM00172803
- Conditions
- Endodontically Treated Teeth
- Keywords
- Ceramic, Crown, Endocrown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Posted 13 Jul 2026
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 longitudinal clinical trial to study the association of preparation design on the internal and marginal adaptation of the resulting restorations and the long-term clinical performance of chairside CAD/CAM endocrown restorations. Advanced lithium disilicate chairside CAD/CAM endocrowns (CEREC Tessera/Dentsply Sirona) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (Prime and Bond Elect/Dentsply Sirona) and a dual cure resin adhesive cement (Calibra Ceram/Dentsply Sirona). All restorations will be followed over five years of clinical service.
Detailed description
Endodontically treated teeth commonly present with extensive tooth structure loss due to caries, trauma, prior restorative treatment, and the endodontic access. These structural deficiencies lead to an increase in cusp deflection, crown fractures, microleakage, and decreased sensory feedback during function which greatly increases the possibility of tooth fracture.As a result, endodontically treated teeth require a full cuspal coverage restoration to prevent microleakage, restore function, and provide cuspal protection against tooth fracture. The most common restoration for endodontically treated teeth is core build-up, with or without a post, and full coverage crown.
This process requires multiple appointments with many technical steps ultimately leading to more chair time, treatment cost, and potential iatrogenic damage to the tooth. An alternative treatment is the endocrown, which utilizes the internal walls of the pulp chamber for macroretention and incorporates the core and crown in a monolithic restoration. The restoration is fabricated utilizing chairside CAD/CAM technology and is adhesively bonded to the tooth with resin cement. The EndoCrown restoration is more conservative relative to tooth structure loss, less expensive, and requires less chair time to complete when compared to conventional treatment while having comparable clinical longevity in molar teeth.
This investigation will be a longitudinal clinical trial to study the association of preparation design on the internal and marginal adaptation of the resulting restorations and the long-term clinical performance of chairside CAD/CAM endocrown restorations. Advanced lithium disilicate chairside CAD/CAM endocrowns (CEREC Tessera/Dentsply Sirona) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (Prime and Bond Elect/Dentsply Sirona) and a dual cure resin adhesive cement (Calibra Ceram/Dentsply Sirona). All restorations will be followed over five years of clinical service.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endocrown Onlay Restoration | Experimental | Device: CEREC TesseraEndocrown onlay preparation = Buccal and lingual walls are intact with an occlusal-gingival height at least equal to half the original crown height of the tooth. Remaining buccal and lingual walls maintain a thickness ≥ 2.0 mm. |
| Endocrown Shoulder Restorations | Experimental | Device: CEREC TesseraEndocrown shoulder preparation = Buccal and/or lingual walls are less than half the original occlusal-gingival height of the tooth or the buccal or lingual surfaces were previously prepared axially due to a prior restoration. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject in need of final restoration following molar endodontic therapy
- Subject age 18 or above -
Key exclusion criteria (12 listed)
- Teeth with remaining symptoms following endodontic therapy
- Teeth which have experienced endodontic complications to include treated perforations, internal or external resorption, or separated endodontic files.
- Teeth with exposure of the root canal filling material to the oral environment for greater than two weeks
- Teeth diagnosed with symptoms of incomplete tooth fracture
- Teeth with no adjacent or opposing tooth
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 TesseraFull ceramic endocrown restorations will be made from the high strength ceramic, CEREC Tessera | Device | Endocrown Onlay Restoration, Endocrown Shoulder Restorations |
Primary outcome
Restoration Failure
Time frame: from delivery of the crown up to 3 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 three years.
2 secondary outcomes
Restoration Loss of Retention
Time frame: from delivery of crown up to 3 years
Margin Staining
Time frame: from delivery of crown up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Endodontically Treated Teeth
Active, not recruiting
Clinical Comparison of Lithium Disilicate and 3D-Printed Resin Endocrowns
Endodontically Treated Teeth, Nonvital Teeth
Recruiting
Conservative Versus Conventional Restorative Approach for Endodontically Treated Posterior Teeth
Root Canal Treated Posterior Teeth, Endodontically-Treated Teeth
Not yet recruiting
Predictable Method for Restoring Endodontically Treated Teeth, Comparing Indirect and Direct Methods and Materials in Aesthetic Dentistry.
Endodontically Treated Teeth Requiring Indirect Restorative Treatment
Recruiting
Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
Apical Periodontitis, Endodontically Treated Teeth
Active, not recruiting
An In-vivo Survival Rate of Different Onlay Materials Placed Over Endodontically Treated Molar Teeth
Dental Restoration Failures
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 CEREC Tessera in people with Endodontically Treated Teeth, 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 13 Jul 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?
Yes. Results are posted in the registry (first posted 13 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Restoration Failure (time frame: from delivery of the crown up to 3 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 13 Jul 2026.