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insufficient clinical performance which might have led to AE
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A clinical trial with an experimental glass ceramic (shades A1, A2 and A3) to ensure the safety and efficacy of the product. It is a study with single-arm in which inlays and onlays for molars and premolars are adhesively luted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inlay/Onlay | Experimental | shades A1, A2 and A3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indirect restorative treatment with a glass ceramic | Device | Inlays and onlays of glass ceramic for molars and premolars are adhesively luted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate of Inlays and Onlays | Inlay and onlay restorations were examined by a dentist | Baseline (7-10 days after insertion of restoration) |
| 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. surface lustre, Staining, fracture of material, retension, occlusal contour and wear, and colour match of restorations) | Baseline (7-10 days after insertion of restoration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ivoclar Vivadent | Schaan | 9494 | Liechtenstein |
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The recruitment period lasted from 14.09.2021-15.11.2021 in the dental clinic.
| ID | Title | Description |
|---|---|---|
| FG000 | Inlay/Onlay | indirect restorative treatment with a glass ceramic: Inlays and onlays of glass ceramic for molars and premolars are adhesively luted. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inlay/Onlay | indirect restorative treatment with a glass ceramic: Inlays and onlays of glass ceramic for molars and premolars are adhesively luted. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Survival Rate of Inlays and Onlays | Inlay and onlay restorations were examined by a dentist | Posted | Number | Inlays/Onlays | Baseline (7-10 days after insertion of restoration) | Inlays/Onlays | Inlays/Onlays |
|
|
Baseline
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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 | Inlay/Onlay | indirect restorative treatment with a glass ceramic: Inlays and onlays of glass ceramic for molars and premolars are adhesively luted. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Team Leader Study Management | Ivoclar Vivadent AG | +4232353780 | patrizia.elkuch-hoch@ivoclar.com |
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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 | Sep 7, 2021 | Nov 20, 2023 | Prot_SAP_000.pdf |
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| participants |
|
| 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 |
|
| Inlays/Onlays |
|
|
| Secondary | Quality Criteria (Modified FDI Criteria) | assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" (e.g. surface lustre, Staining, fracture of material, retension, occlusal contour and wear, and colour match of restorations) | Posted | Number | inlays/onlays | Baseline (7-10 days after insertion of restoration) | Inlays/Onlays | Inlays/Onlays |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
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| Title | Measurements |
|---|---|
|
| FDI 2a (Surface Staining), FDI Score 2-5 |
|
| FDI 2b (Margin Staining), FDI Score 1 |
|
| FDI 2b (Margin Staining), FDI Score 2-5 |
|
| FDI 3 (Color Match), FDI Score 1 |
|
| FDI 3 (Color Match), FDI Score 2 |
|
| FDI 3 (Color Match), FDI Score 3-5 |
|
| FDI 3 (Translucency), FDI Score 1 |
|
| FDI 3 (Translucency), FDI Score 2 |
|
| FDI 3 (Translucency), FDI Score 3-5 |
|
| FDI 5 (Fractures of material and retention), FDI Score 1 |
|
| FDI 5 (Fractures of material and retention), FDI Score 2 |
|
| FDI 5 (Fractures of material and retention), FDI Score 3-5 |
|
| FDI 6 (Marginal adaptation), FDI Score 1 |
|
| FDI 6 (Marginal adaptation), FDI Score 2-5 |
|
| FDI 7a (Occlusal contour and wear, qualitatively), FDI Score 1 |
|
| FDI 7a (Occlusal contour and wear, qualitatively), FDI Score 2-5 |
|
| FDI 10 (Patient's view), FDI Score 1 |
|
| FDI 10 (Patient's view), FDI Score 2-5 |
|
| FDI 11 (Postoperative (hyper-)sensitivity and tooth vitality), FDI Score 1 |
|
| FDI 11 (Postoperative (hyper-)sensitivity and tooth vitality), FDI Score 2-5 |
|
| FDI 12 (Recurrence of caries (CAR), erosion, abfraction), FDI Score 1 |
|
| FDI 12 (Recurrence of caries (CAR), erosion, abfraction), FDI Score 2-5 |
|
| FDI 13 (Tooth integrity (enamel cracks, tooth fractures), FDI Score 1 |
|
| FDI 13 (Tooth integrity (enamel cracks, tooth fractures), FDI Score 2-5 |
|
| FDI 15 (Adjacent mucosa), FDI Score 1 |
|
| FDI 15 (Adjacent mucosa), FDI Score 2-5 |
|