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

Running, not enrolling

Conditions studied: Dental Prosthesis Failure, Dental Prosthesis Complication

In brief

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.

Key facts

Study ID

NCT05752539

Run by

Dentsply Sirona Implants and Consumables

People needed

25

Starts

2023-10-10

Expected to finish

2028-02-20

Last updated by the study team

2025-08-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Department of Cariology, Restorative Sciences, and Endodontics at School of Dentistry — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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