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Completed

NCT Number: NCT03716817

TetricCAD Crown Clinical Study

This investigation will be a clinical trial to study the performance of a new resin-based ceramic material for crowns. The material has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

The study will be composed of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per patient will be completed. All the crowns will be made from the same resilient ceramic CAD/CAM block(Tetric CAD/Ivoclar Vivadent). The crowns are placed using an adhesive bonding process including a total etch process with a universal adhesive (Adhese by Ivoclar Vivadent) and dual-cured resin cement (Variolink Esthetic by Ivoclar Vivadent). The crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. At each appointment, an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
  • reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
  • Teeth to be vital and asymptomatic prior to treatment
  • No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.

Exclusion criteria

  • Devital or sensitive teeth
  • Teeth with prior endodontic treatment of any kind
  • Teeth with a history of direct or indirect pulp capping procedures
  • Patients with significant untreated dental disease to include periodontitis and rampant caries
  • Pregnant or lactating women
  • Patients with a history of allergies to any of the materials to be used in the study
  • Patients unable to return for the recall appointments

Treatment and study plan

Tetric CAD

Device

Resilient ceramic crowns (Tetric CAD by Ivoclar Vivadent) are placed using an adhesive bonding process including a total etch process with a universal adhesive (Adhese by Ivoclar Vivadent) and dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).

Primary outcomes

  1. Crown Failure

    Time frame: from delivery of the crown up to 5 years

    Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and five years.

Secondary outcomes

  1. Crown Loss of Retention

    Time frame: from delivery of the crown up to 5 years

    Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.

  2. Tooth Sensitivity

    Time frame: from delivery of the crown up to 5 years

    Tooth Sensitivity is evaluated as either "0" if the subject reports that there is NO sensitivity for the tooth with the study crown, or "1" if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below.

  3. Margin Staining

    Time frame: from delivery of the crown up to 5 years

    Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth, or "1" if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Ivoclar Vivadent AG

Registry information

Official study title

Clinical Evaluation of Chairside CAD/CAM Resilient Ceramic Crowns

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2018
Registry last updated
Apr 28, 2026

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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