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
|Condition or disease||Intervention/treatment||Phase|
|Fractured Tooth Decayed Tooth Unsatisfactory Restoration of Tooth||Device: Tetric CAD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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).
- 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.
- 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.
- 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.
- 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.
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
|United States, Michigan|
|University of Michigan School of Dentistry|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Dennis Fasbinder, DDS||University of Michigan|