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The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow for treatment of non-carious cervical lesions. Each participant receives two different fillings (test- and control material) in two different teeth. The fillings are assessed according to selected FDI criteria at baseline (7-10 days after filling placement) and after 1, 6, 12, 24, 36 and 60 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test goup TM Flow | Experimental | The newly developed flowable composite TM Flow will be used for the restoration of NCCLs in the test group. The treatment workflow is very similar to other flowable composites. |
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| Control group Tetric EvoFlow | Active Comparator | The well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restoration of non-carious cervical lesions | Device | Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Hypersensitivity | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" FDI 1: no complaint FDI 2: minor complaint FDI 3: distinct pain FDI 4: persistent pain for prolonged period of time FDI 5: treatment unavoidable | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Functional (e.g. Fracture of the Material and Retention), Biological (e.g. Caries at Restoration Margins) and Aesthetic (e.g. Color Match) Properties of the Restorations | will be assessed acooriding to FDI criteria | 5 years |
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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 | Test goup TM Flow | The newly developed flowable composite TM Flow will be used for the restoration of NCCLs in the test group. The treatment workflow is very similar to other flowable composites. Restoration of non-carious cervical lesions: Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites. |
| FG001 | Control group Tetric EvoFlow | The well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group. Restoration of non-carious cervical lesions: Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test goup TM Flow | The newly developed flowable composite TM Flow will be used for the restoration of NCCLs in the test group. The treatment workflow is very similar to other flowable composites. Restoration of non-carious cervical lesions: Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites. |
| 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 | 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 | Postoperative Hypersensitivity | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" FDI 1: no complaint FDI 2: minor complaint FDI 3: distinct pain FDI 4: persistent pain for prolonged period of time FDI 5: treatment unavoidable | Posted | Number | Teeth | 1 month | Teeth | Teeth |
|
1 Month Recall
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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 | Test goup TM Flow | The newly developed flowable composite TM Flow will be used for the restoration of NCCLs in the test group. The treatment workflow is very similar to other flowable composites. Restoration of non-carious cervical lesions: Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites. |
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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 | Jan 17, 2024 | Sep 26, 2025 | Prot_SAP_002.pdf |
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Split-Mouth Design
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| BG001 | Control group Tetric EvoFlow | The well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group. Restoration of non-carious cervical lesions: Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites. |
| BG002 | Total | Total of all reporting groups |
| Teeth |
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| Participants |
| Participants |
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| Sex/Gender, Customized | Number | 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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| OG001 | Control group Tetric EvoFlow | The well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group. Restoration of non-carious cervical lesions: Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites. |
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| Secondary | Evaluation of Functional (e.g. Fracture of the Material and Retention), Biological (e.g. Caries at Restoration Margins) and Aesthetic (e.g. Color Match) Properties of the Restorations | will be assessed acooriding to FDI criteria | Not Posted | 5 years | Participants |
| 0 |
| 66 |
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | Control group Tetric EvoFlow | The well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group. Restoration of non-carious cervical lesions: Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites. | 0 | 66 | 0 | 66 | 0 | 66 |
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| Title | Measurements |
|---|---|
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