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

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: Active, not recruiting
• Conditions: Dental Prosthesis Failure; Dental Prosthesis Complication
• Intervention / Treatment: Device: CEREC System by Dentsply Sirona

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the 5 years visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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

Outcome Measure	Measure Description	Time Frame
Evaluation of soft tissue health through Papilla index	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	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	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

• Sponsor: Dentsply Sirona Implants and Consumables
• Investigators: Principal Investigator: Dennis J. Fasbinder, DDS, Clinical Professor of Dentistry, Department of Cardiology, Restorative Sciences, and Endodontics

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): February 20, 2028
• Study Completion (Estimated): February 20, 2028

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Prosthesis Failure
• Other Study ID 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