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

NCT ID: NCT05752539

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2028-02-20

Brief 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. 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.

Conditions

Dental Prosthesis Failure; Dental Prosthesis Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

CEREC System by Dentsply Sirona

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis J. Fasbinder, DDS

Role: PRINCIPAL_INVESTIGATOR

Clinical Professor of Dentistry, Department of Cardiology, Restorative Sciences, and Endodontics

Locations

Department of Cariology, Restorative Sciences, and Endodontics at School of Dentistry

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00226401

Identifier Type: -

Identifier Source: org_study_id