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

NCT05752539 | Active Not Recruiting FDA Device

• 1 other identifier: HUM00226401
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of restoration condition measured through Modified FDI criteria

  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).

  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 Outcomes (3)

• Evaluation of soft tissue health through Papilla index

  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

  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

  At the 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, 4 years visit, and at the 5 years visit

Interventions

CEREC System by Dentsply Sirona DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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).

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (1)

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

Ann Arbor, Michigan, 48109-1078, United States

Location

Study Officials

• Dennis J. Fasbinder, DDS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: March 2, 2023
• Study Start: October 10, 2023
• Primary Completion (Estimated): February 20, 2028
• Study Completion (Estimated): February 20, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)