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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
| 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 |
Inclusion Criteria:
(A maximum of two single dental implant restorations per subject will be restored.)
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dennis J. Fasbinder, DDS | Clinical Professor of Dentistry, Department of Cardiology, Restorative Sciences, and Endodontics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cariology, Restorative Sciences, and Endodontics at School of Dentistry | Ann Arbor | Michigan | 48109-1078 | United States |
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| 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 |
| 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 |