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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00241710 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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This investigation will be a randomized, prospective, longitudinal clinical trial to study the clinical performance of a new monolithic, zirconia material with shade, translucency and material graduation for chairside CAD/CAM crowns. The restorations will be luted either with a self-adhesive luting material or a conventional cement. The crowns will be evaluated for a period of two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpeedCEM Plus luted crowns | Experimental | crowns delivered with a self-adhesive, self-curing resin cement (SpeedCEM Plus\Ivoclar Vivadent AG) |
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| ZirCAD Cement cemented crowns | Experimental | crowns delivered with a resin modified glass ionomer cement (ZirCAD Cement\Ivoclar Vivadent AG) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crowns self-adhesively luted | Device | After cavity preparation, the zirconia chairside crown will be placed using SpeedCEM Plus. The excess will be light cured with Bluephase G4 in PreCure mode (950 mW/cm^2). After removal of the excess, the luting material margins will be light-cured again for 20s (1200 mW/cm^2). |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term Post-operative Sensitivity | assessed by patient's weekly feedback for 4 weeks after the treatment rating sensitivity from 1 "no sensitivity" to 4 "severe discomfort noted routinely with cold or pressure stimulation" | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality Criteria (modified FDI criteria) | assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" (e.g. post-operative hypersensitivity, surface lustre, Staining, fracture of material, retension, occlusal contour and wear, and colour match of restorations) | 1 year to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dennis J. Fasbinder, DDS | Contact | (734) 647-4450 | djfas@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dennis J. Fasbinder, DDS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Recruiting | Ann Arbor | Michigan | 48109-1078 | United States |
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| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
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| Crowns conventionally cemented | Device | After cavity preparation, the zirconia chairside crown will be placed using ZirCAD Cement. The excess cement will be removed in the gel phase, either following light curing (5 - 10 seconds per segment) or following self-curing (approximately 2 min after placement). The restoration will be held in position during final curing that is complete 4 min 30 s after placement. |
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