Dental Prosthesis FailureNCT05752539
Clinical Evaluation of Implants Restored With Advanced Lithium Disilicate Screw-retained Crowns
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 is a prospective observational clinical trial to evaluate the clinical performance of the Cerec Tessera prosthetic assembly on implants restored with chairside CAD/CAM-generated crowns. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dental Prosthesis Failure, Dental Prosthesis Complication
- What is being tested?
- CEREC System by Dentsply Sirona
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2023to 20 Feb 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients in School of Dentistry clinics that have had at least one dental implant placed and ready for restoration. In addition, all subjects enrolled into the study must fulfill below eligibility criterion.
Who may be able to join
- Adults aged 18-75 years.
- Willing and able to sign and date the informed consent form and HIPAA form.
- Have a single implant that has been successfully osseointegrated and deemed ready for restoration by the surgeon placing the implant.
- (A maximum of two single dental implant restorations per subject will be restored.)
- Have a single implant that is acceptable to be restored with a digital workflow using the CEREC system.
- Have a single implant to be restored with a screw retained advanced lithium disilicate crown.
- Have a single implant with at least one adjacent tooth contact and with an occlusal contact.
Who cannot join
- Not willing to participate in the clinical investigation or not able to understand the content of the clinical investigation.
- Unlikely to be able to comply with clinical investigation procedures according to the Principle Investigator's/Co-investigator's judgement.
- Unable or unwilling to return for recall appointments for a period of 5 years.
- Severe non-compliance to Clinical Investigation Protocol as judged by the PI or Co-investigators.
- Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times.
- Previous enrollment in the present clinical investigation.
- Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and from the clinical investigation site).
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 is a prospective observational clinical trial to evaluate the clinical performance of the Cerec Tessera prosthetic assembly on implants restored with chairside CAD/CAM-generated crowns. This investigation is intended as a Post Market Clinical Follow-up study for the product Cerec Tessera and its prosthetic assembly for implants, which will serve as a life-cycle approach to safety, backed up by clinical data and post-market monitoring.
- Being tested
- CEREC System by Dentsply Sirona
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEREC System by Dentsply SironaDevice
CEREC Tessera blocks achieve exceptional three-way performance through a unique chemistry that incorporates two complementary crystal structures within a glassy zirconia matrix. These two crystals work together to create an unprecedented fusion of strength and beauty in one block while significantly improving overall processing time.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of restoration condition measured through Modified FDI criteria
Modified FDI criteria is based on the questionnaire "The Modified Clinical Evaluation Criteria for Ceramic Crowns" with consists of questions related to: A. Aesthetic properties and B. Functional properties.
Measured: At the 5 years visit
Secondary outcomes (2)
Evaluation of restoration condition measured through Modified FDI criteria
Modified FDI criteria is based on the questionnaire "The Modified Clinical Evaluation Criteria for Ceramic Crowns" with consists of questions related to: A. Aesthetic properties and B. Functional properties.
Measured: At the 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, and at the 4 years visit.
Change in bone health compared to baseline (i.e., restoration visit).
The level of the bone around the dental implant will be qualitatively compared to the radiograph taken at the time the restoration was delivered as well as a Mobility Index.
Measured: At the baseline and restoration visit, 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, 4 years visit, and at the 5 years visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start10 Oct 2023
- Primary completion20 Feb 2028 (estimated)
- Study completion20 Feb 2028 (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
- 25 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, DDS, Principal investigator, Clinical Professor of Dentistry, Department of Cardiology, Restorative Sciences, and Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752539
- Sponsor's protocol ID
- HUM00226401
- Status last verified
- Aug 2026
- First submitted
- 16 Jan 2023
- Last updated
- 27 Aug 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Implants Restored With Advanced Lithium Disilicate Screw-retained Crowns
- ClinicalTrials.gov ID
- NCT05752539
- Acronym / sponsor ID
- HUM00226401
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 20 Feb 2028 (estimated)
- Study completion
- 20 Feb 2028 (estimated)
- First posted
- 2 Mar 2023 (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 is a prospective observational clinical trial to evaluate the clinical performance of the Cerec Tessera prosthetic assembly on implants restored with chairside CAD/CAM-generated crowns. This investigation is intended as a Post Market Clinical Follow-up study for the product Cerec Tessera and its prosthetic assembly for implants, which will serve as a life-cycle approach to safety, backed up by clinical data and post-market monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients in School of Dentistry clinics that have had at least one dental implant placed and ready for restoration. In addition, all subjects enrolled into the study must fulfill below eligibility criterion.
Key inclusion criteria (7 listed)
- Adults aged 18-75 years.
- Willing and able to sign and date the informed consent form and HIPAA form.
- Have a single implant that has been successfully osseointegrated and deemed ready for restoration by the surgeon placing the implant.
- (A maximum of two single dental implant restorations per subject will be restored.)
- Have a single implant that is acceptable to be restored with a digital workflow using the CEREC system.
Key exclusion criteria (7 listed)
- Not willing to participate in the clinical investigation or not able to understand the content of the clinical investigation.
- Unlikely to be able to comply with clinical investigation procedures according to the Principle Investigator's/Co-investigator's judgement.
- Unable or unwilling to return for recall appointments for a period of 5 years.
- Severe non-compliance to Clinical Investigation Protocol as judged by the PI or Co-investigators.
- Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times.
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 System by Dentsply SironaCEREC Tessera blocks achieve exceptional three-way performance through a unique chemistry that incorporates two complementary crystal structures within a glassy zirconia matrix. These two crystals work together to create an unprecedented fusion of strength and beauty in one block while significantly improving overall processing time. | Device | – |
Primary outcome
Evaluation of restoration condition measured through Modified FDI criteria
Time frame: At the 5 years visit
Modified FDI criteria is based on the questionnaire "The Modified Clinical Evaluation Criteria for Ceramic Crowns" with consists of questions related to: A. Aesthetic properties and B. Functional properties.
2 secondary outcomes
Evaluation of restoration condition measured through Modified FDI criteria
Time frame: At the 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, and at the 4 years visit.
Change in bone health compared to baseline (i.e., restoration visit).
Time frame: At the baseline and restoration visit, 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, 4 years visit, and at the 5 years visit
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 27 Aug 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, DDS 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 7 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 27 Aug 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 restoration condition measured through Modified FDI criteria (time frame: At the 5 years visit). 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 27 Aug 2026.