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NCT Number: NCT05752539

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Dental Prosthesis Failure Dental Prosthesis Complication

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cariology, Restorative Sciences, and Endodontics at School of Dentistry

Ann Arbor, Michigan, 48109-1078, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Evaluation of restoration condition measured through Modified FDI criteria

    Time frame: At the 5 years visit

    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.

Secondary outcomes

  1. Evaluation of restoration condition measured through Modified FDI criteria

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

    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.

  2. Change in bone health compared to baseline (i.e., restoration visit).

    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

    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.

Other outcomes

  1. Evaluation of soft tissue health through Papilla index

    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

    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.

  2. Evaluation of soft tissue health through Gingival index

    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

    Gingival index (based upon the standard Loe & Silness Index, 1963). Gingival score (visual) for gingival area nearest to the crown margin, score 0 - 3.

  3. Evaluation of soft tissue health through Plaque index

    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

    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.

Sponsors and collaborators

Lead sponsor

Dentsply Sirona Implants and Consumables

Industry

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 2, 2023
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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