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Investigation on the clinical performance of a new dental adhesive when used in direct filling therapy after phosphoric acid etching.
Hypothesis: The new adhesive shows an acceptable clinical performance and allows a good filling quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adhese One F Upgrade | Experimental | Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adhese One F Upgrade | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Success | Clinical success is defined as no postoperative hypersensitivity and no loss of the restoration. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Quality | The clinical quality of the restorations will be evaluated according to semi-quantitative clinical evaluation (SQUACE) criteria and compared at all time points and at the end of the study. SQUACE is a published semi-quantitative method to evaluate the clinical success of dental restorations that is based on the commonly used USPHS criteria. The quality of the restoration is rated according to the SQUACE scale and classified as acceptable (patients with satisfactory clinical outcome) or not acceptable (patients with unsatisfactory clinical outcome). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnd Peschke, Dr. | Ivoclar Vivadent AG | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adhese One F Upgrade | Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol). Adhese One F Upgrade |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adhese One F Upgrade | Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol). Adhese One F Upgrade |
| 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, 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 | Number of Participants With Clinical Success | Clinical success is defined as no postoperative hypersensitivity and no loss of the restoration. | Posted | Count of Participants | Participants | 1 week |
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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 | Adhese One F Upgrade | Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol). Adhese One F Upgrade |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erik Braziulis | Ivoclar Vivadent AG | erik.braziulis@ivoclarvivadent.com |
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| 3 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Clinical Quality | The clinical quality of the restorations will be evaluated according to semi-quantitative clinical evaluation (SQUACE) criteria and compared at all time points and at the end of the study. SQUACE is a published semi-quantitative method to evaluate the clinical success of dental restorations that is based on the commonly used USPHS criteria. The quality of the restoration is rated according to the SQUACE scale and classified as acceptable (patients with satisfactory clinical outcome) or not acceptable (patients with unsatisfactory clinical outcome). | Posted | Count of Participants | Participants | 3 years |
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| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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