TetricCAD Crown Clinical Study

NCT03716817 | Completed Results FDA Device

• 1 other identifier: HUM00145596
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fractured Tooth; Decayed Tooth; Unsatisfactory Restoration of Tooth

Keywords

Crown; Ceramic; CAD/CAM

Outcome Measures

Primary Outcomes (1)

• Crown Failure

  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.

  from delivery of the crown up to 5 years

Secondary Outcomes (3)

• Crown Loss of Retention

  from delivery of the crown up to 5 years

• Tooth Sensitivity

  from delivery of the crown up to 5 years

• Margin Staining

  from delivery of the crown up to 5 years

Study Arms (1)

Tetric CAD Crown

EXPERIMENTAL

Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).

Device: Tetric CAD

Interventions

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).

Tetric CAD Crown

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Ivoclar Vivadent AG: collaborator

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Tooth Fractures

Condition Hierarchy (Ancestors)

Tooth Injuries; Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries

Limitations and Caveats

No limitations or caveats to be reported

Results Point of Contact

• Title: Dr. Dennis Fasbinder
• Organization: University of Michigan

djfas@umich.edu

7347643155

Study Officials

• Dennis Fasbinder, DDS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinica Professor

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: October 23, 2018
• Study Start: October 1, 2018
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)