An interventional study of Restoration of non-carious cervical lesions in Non-carious Cervical Lesions, sponsored by Ivoclar Vivadent AG. Active, not recruiting at 1 site in Liechtenstein. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-10-23.
Sponsored by Ivoclar Vivadent AG · Not applicable, Interventional, and Treatment
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.
Ivoclar Vivadent AG is the lead sponsor of 21 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Restoration of non-carious cervical lesions
The well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group.
Device: 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.
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
Time frame: 1 month
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
Time frame: 5 years
| Milestone | Test goup TM Flow | Control group Tetric EvoFlow |
|---|---|---|
| Started | 66 | 66 |
| Completed | 66 | 66 |
| Not completed | 0 | 0 |
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
| Teeth | Test goup TM Flow | Control group Tetric EvoFlow |
|---|---|---|
| FDI Score 1 | 66 | 66 |
| FDI Score 2-5 | 0 | 0 |
will be assessed acooriding to FDI criteria
Results for this outcome have not been posted.
Collected over 1 Month Recall. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test goup TM Flow | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) |
| Control group Tetric EvoFlow | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) |
| Age, Customized(Participants) | Test goup TM Flow | Control group Tetric EvoFlow | Total |
|---|---|---|---|
| <= 18 years | 0 | 0 | 0 |
| 18 to 65 years | 66 | 66 | 66 |
| > 65 years | 0 | 0 | 0 |
| Sex/Gender, Customized(Participants) | Test goup TM Flow | Control group Tetric EvoFlow | Total |
|---|---|---|---|
| Female | 15 | 15 | 15 |
| Male | 51 | 51 | 51 |
| Race and Ethnicity Not Collected(Participants) | Test goup TM Flow | Control group Tetric EvoFlow | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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Plan to share: No
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Ivoclar Vivadent AG