Clinical trial NCT05752539: Clinical Evaluation of Implants Restored With Advanced Lithium Disilicate Screw-retained Crowns
Official title: Clinical Evaluation of Implants Restored With Advanced Lithium Disilicate Screw-retained Crowns
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dental Prosthesis Failure
Dental Prosthesis Complication
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2023-03-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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).

Primary outcomes:
measure: Evaluation of restoration condition measured through Modified FDI criteria
timeFrame: At the 5 years visit
Secondary outcomes:
measure: Evaluation of restoration condition measured through Modified FDI criteria
timeFrame: At the 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, and at the 4 years visit.
measure: Change in bone health compared to baseline (i.e., restoration visit).
timeFrame: 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:
measure: Evaluation of soft tissue health through Papilla index
timeFrame: At the 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, 4 years visit, and at the 5 years visit
measure: Evaluation of soft tissue health through Gingival index
timeFrame: At the 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, 4 years visit, and at the 5 years visit
measure: Evaluation of soft tissue health through Plaque index
timeFrame: At the 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, 4 years visit, and at the 5 years visit
Locations:
city: Ann Arbor
country: United States
facility: Department of Cariology, Restorative Sciences, and Endodontics at School of Dentistry
state: Michigan
Study officials:
affiliation: Clinical Professor of Dentistry, Department of Cardiology, Restorative Sciences, and Endodontics
name: Dennis J. Fasbinder, DDS
role: PRINCIPAL_INVESTIGATOR
References: