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| Name | Class |
|---|---|
| Ivoclar Vivadent AG | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetric CAD Crown | Experimental | Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Crown Loss of Retention | Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown. | from delivery of the crown up to 5 years |
| Tooth Sensitivity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Fasbinder, DDS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Ann Arbor | Michigan | 48109 | United States |
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The patient population was selected from current patients under clinical treatment at the University of Michigan Dental Clinics between October 2018 and April 2019.
| ID | Title | Description |
|---|---|---|
| FG000 | TetricCAD Crowns | TetricCAD crowns will be cemented with variolink and followed over the time of five years |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| 6 month |
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| 1 year |
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| 2 years |
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| 3 years |
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| 5 years |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tetric CAD Crown | Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age was not collected from any participant. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Teeth restored with crowns. Four of the crowns fractured during the study requiring replacement of the crowns. One crown fractured at 18 months, one at 38 months, one at 57 months, and another at 58 months. New crowns were placed for each case. | Posted | Number | crowns | from delivery of the crown up to 5 years | teeth | teeth |
|
from enrollment until end of follow-up, up to 5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tetric CAD Crown | Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent). |
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No limitations or caveats to be reported
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dennis Fasbinder | University of Michigan | 7347643155 | djfas@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2018 | Apr 6, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D014082 | Tooth Fractures |
| ID | Term |
|---|---|
| D018677 | Tooth Injuries |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D014947 | Wounds and Injuries |
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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.
| from delivery of the crown up to 5 years |
| Margin Staining | 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. | from delivery of the crown up to 5 years |
|
| Count of Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
| teeth |
|
|
| Secondary | Crown Loss of Retention | Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown. | Number of crowns that debonded during the study | Posted | Number | crowns | from delivery of the crown up to 5 years | crowns | crowns |
|
|
|
| Secondary | Tooth Sensitivity | 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. | Number of teeth with crowns that had tooth sensitivity. | Posted | Number | teeth | from delivery of the crown up to 5 years | teeth | teeth |
|
|
|
| Secondary | Margin Staining | 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. | Number of crowns with margin staining. | Posted | Number | teeth | from delivery of the crown up to 5 years | teeth | teeth |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
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