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Active, not recruitingNCT05752539Updated Aug 27, 2026

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

An observational study in Dental Prosthesis Failure and Dental Prosthesis Complication, sponsored by Dentsply Sirona Implants and Consumables. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Dentsply Sirona Implants and Consumables · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Dental Prosthesis Failure
  • Dental Prosthesis Complication
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In context

Lead sponsor

Dentsply Sirona Implants and Consumables is the lead sponsor of 35 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No

Interventions

  • DeviceCEREC 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.

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What researchers measure

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.

    Time frame: At the 5 years visit

Secondary 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.

    Time frame: At the 4 weeks visit, 9 months visit, 18 months visit, 30 months visit, and at the 4 years visit.

  2. 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.

    Time frame: 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

  1. 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.

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

  2. 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.

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

  3. 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.

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

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Study locations

1 site
  • Department of Cariology, Restorative Sciences, and Endodontics at School of Dentistry
    Ann Arbor, Michigan 48109-1078, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05752539
Lead sponsor
Dentsply Sirona Implants and Consumables
Responsible party
Sponsor
First posted
Mar 2, 2023
Start date
Oct 10, 2023
Primary completion
Feb 20, 2028 (estimated)
Completion
Feb 20, 2028 (estimated)
Last update
Aug 27, 2026

Study contacts

Dennis J. Fasbinder, DDS
principal investigator · Clinical Professor of Dentistry, Department of Cardiology, Restorative Sciences, and Endodontics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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