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COVID, loss of funding
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| Name | Class |
|---|---|
| Dentsply Sirona Inc. | INDUSTRY |
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This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic 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. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. 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 two groups 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 high strength ceramic material (Celtra Duo/Dentsply Sirona). The two groups of crowns will be made using two different processes to create the surface texture and finish for the crown. One group of Celtra Duo crowns (Group 1) will be glaze-fired in a porcelain oven and the second group (Group 2) will be hand-polished. All the crowns will be cemented using two adhesive techniques. All of the oven-fired, glazed crowns will be cemented using the self-etching, self-adhesive resin cement technique (Calibra Universal Cement/Dentsply). All of the hand polished crowns will be cemented using an adhesive bonding technique using Prime & Bond Elect (Dentsply) with a dual cured resin cement (Calibra Ceram/Dentsply). 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 |
|---|---|---|---|
| Glazed Fired, Calibra Céram | Experimental | Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement |
|
| Hand Polished, Calibra Universal | Experimental | Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celtra Duo | Device | Full ceramic crowns will be made from the high strength ceramic, Celtra Duo. |
|
| 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 three years. | from delivery of the crown up to 3 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. | 3 years |
| Tooth Sensitivity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis J Fasbinder, DDS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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Recall at 5 years not funded by sponsor, therefore data not collected up to 5 years
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| ID | Title | Description |
|---|---|---|
| FG000 | Glazed Fired, Calibra Céram | Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo. |
| FG001 | Hand Polished, Calibra Universal | Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 6 Months |
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| 1 Year |
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| 2 Years |
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| 3 Years |
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Number of teeth restored with crowns
| ID | Title | Description |
|---|---|---|
| BG000 | Glazed Fired, Calibra Céram | Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo. |
| BG001 | Hand Polished, Calibra Universal |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age data 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 three years. | teeth restored with crowns | Posted | Number | crowns | from delivery of the crown up to 3 years | Teeth | Teeth |
|
from baseline to 3 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 | Glazed Fired, Calibra Céram | Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dennis J. Fasbinder, DDS | University of Michigan | 7346474450 | 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 | May 19, 2022 | Jan 19, 2023 | Prot_SAP_000.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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Final surface fabrication was not identified in the treatment process until the crown was milled.
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 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 3 years |
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Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo. |
| BG002 | Total | Total of all reporting groups |
| number of teeth restored with crowns |
|
Age data not collected from any participant
| Count of Participants |
| Participants |
| Participants |
|
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| Sex: Female, Male | Count of Participants | Participants | Participants |
|
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| 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 | Posted | Number | crowns | 3 years | Teeth | Teeth |
|
|
|
| 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 crown | Posted | Number | Teeth | 3 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 | Posted | Number | crowns | from delivery of the crown up to 3 years | Teeth | Teeth |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Hand Polished, Calibra Universal | Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement Celtra Duo: Full ceramic crowns will be made from the high strength ceramic, Celtra Duo. | 0 | 32 | 0 | 32 | 0 | 32 |
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