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

Dental Prosthesis Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05752539
• Other study ID #: HUM00226401
• Status: Active, not recruiting
• Start date: October 10, 2023
• Est. completion date: February 20, 2028

Study information

• Verified date: June 2024
• Source: Dentsply Sirona Implants and Consumables
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: February 20, 2028
• Est. primary completion date: February 20, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dental Prosthesis Complication
• Dental Prosthesis Failure
• Prosthesis Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Department of Cariology, Restorative Sciences, and Endodontics at School of Dentistry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants and Consumables

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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.
Secondary	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