Clinical Evaluation of Implants Restored With Advanced Lithium Disilicate Screw-retained Crowns

August 25, 2026 updated by: Dentsply Sirona Implants and Consumables
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At the 5 years visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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
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.
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of soft tissue health through Papilla index
Time Frame: At the 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, 4 years visit, and at the 5 years visit
Papilla contour measurements of the interproximal papilla measured from a reference line through the highest gingival curvatures or the implant crown restoration on the mesio-buccal and disto-buccal side with the adjacent permanent tooth. Papilla index (Jemt, 1997) with gradings from 0 - 4.
At the 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, 4 years visit, and at the 5 years visit
Evaluation of soft tissue health through Gingival index
Time Frame: At the 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, 4 years visit, and at the 5 years visit
Gingival index (based upon the standard Loe & Silness Index, 1963). Gingival score (visual) for gingival area nearest to the crown margin, score 0 - 3.
At the 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, 4 years visit, and at the 5 years visit
Evaluation of soft tissue health through Plaque index
Time Frame: At the 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, 4 years visit, and at the 5 years visit
Plaque index (based upon the standard Silness & Loe Index, 1964). Plaque score (visual) for facial gingival area nearest to the crown margin, score 0 - 3.
At the 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, 4 years visit, and at the 5 years visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dentsply Sirona Implants and Consumables

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dennis J. Fasbinder, DDS, Clinical Professor of Dentistry, Department of Cardiology, Restorative Sciences, and Endodontics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00226401

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings