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The overall aim of this study is to evaluate the clinical performance and safety of the new dental dual-cure adhesive for luting indirect ceramic restorations (inlays and onlays). The primary aim is to determine the rate of postoperative hypersensitivity occurrence after using the new adhesive for the placement of indirect restorations. The secondary objective of this study is to assess the long-term clinical performance of the new adhesive in terms of marginal quality, retention/fracture rate of the ceramic restorations, and vitality/fracture rate of the restored teeth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New dual-cure adhesive | Experimental | The newly developed dual-cure adhesive will be used for the placement of indirect restorations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placement of indirect dental restoration | Device | The newly developed dual-cure adhesive will be used for the placement of indirect restorations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Hypersensitivity | will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Fracture Rate | will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome) | 5 years |
| Marginal Quality | will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ivoclar Vivadent AG | Schaan | Liechtenstein | 9494 | Liechtenstein |
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| ID | Title | Description |
|---|---|---|
| FG000 | New dual-cure adhesive | The newly developed dual-cure adhesive will be used for the placement of indirect restorations. Placement of indirect dental restoration: The newly developed dual-cure adhesive will be used for the placement of indirect restorations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | New dual-cure adhesive | The newly developed dual-cure adhesive will be used for the placement of indirect restorations. Placement of indirect dental restoration: The newly developed dual-cure adhesive will be used for the placement of indirect restorations. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Postoperative Hypersensitivity | will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome) | One patient was not able to visit 1-month recall (no-show) | Posted | Number | Restorations | 1 month | Restorations | Restorations |
|
|
1-Month
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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 | New dual-cure adhesive | The newly developed dual-cure adhesive will be used for the placement of indirect restorations. Placement of indirect dental restoration: The newly developed dual-cure adhesive will be used for the placement of indirect restorations. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrealated: Cementation Mistake | General disorders | Non-systematic Assessment | Restoration was removed before Baseline and a new one with a standard workflow was placed. Cementation mistake is unrelated to the test product |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Department 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 | Oct 1, 2024 | Sep 26, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| 5 years |
| Restorations |
|
| Participants |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Restorations |
|
|
| Secondary | Fracture Rate | will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome) | Not Posted | 5 years | Participants |
| Secondary | Marginal Quality | will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome) | Not Posted | 5 years | Participants |
| 0 |
| 45 |
| 0 |
| 45 |
| 3 |
| 45 |
|
| Unrealated: Cementation Mistake | General disorders | Non-systematic Assessment | Cementation mistake of a restoration occured, which is unrelated to the test product. Restorations were not replaced and patients are symptom-free. |
|
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