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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dental Prosthesis Failure, Dental Prosthesis Complication

Intervention / Treatment
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* Device: CEREC System by Dentsply Sirona


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 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.|

What is the study measuring?
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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 |