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TetricCAD Crown Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716817
Recruitment Status : Active, not recruiting
First Posted : October 23, 2018
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
Ivoclar Vivadent AG
Information provided by (Responsible Party):
Dennis Fasbinder, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Fractured Tooth Decayed Tooth Unsatisfactory Restoration of Tooth Device: Tetric CAD Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Chairside CAD/CAM Resilient Ceramic Crowns
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Arm Intervention/treatment
Experimental: Tetric CAD Crown
Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).
Device: Tetric CAD
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 Outcome Measures :
  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 Outcome Measures :
  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 ]
    Patient described sensitivity on a scale of 1 to 4, where 1 means absence of sensitivity (pain) and four means severe discomfort noted routinely with cold or pressure stimulation.

  3. Margin staining [ Time Frame: from delivery of the crown up to 5 years ]
    Margin staining is categorized based on modified US Public Health Service criteria using a four point scale where 1 is no staining and 4 is penetrating stain involving more than 50% of the margin.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716817


Locations
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United States, Michigan
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Ivoclar Vivadent AG
Investigators
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Principal Investigator: Dennis Fasbinder, DDS University of Michigan

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Responsible Party: Dennis Fasbinder, Clinica Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03716817    
Other Study ID Numbers: HUM00145596
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Dennis Fasbinder, University of Michigan:
Crown
Ceramic
CAD/CAM
Additional relevant MeSH terms:
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Dental Caries
Tooth Fractures
Wounds and Injuries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Tooth Injuries