An interventional study of TM Fill in combination with TM Flow in Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars), 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 and the new sculptable composite TM Fill for restoration of class I and class II cavities. The fillings are assessed according to selected FDI (Fédération Dentaire Internationale) criteria at baseline (7-10 days after placement of filling) 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:
TM Fill an TM Flow are used for restoration of class I and class II cavities
Device: TM Fill in combination with TM Flow
The newly developed resin composites (TM Flow in combination with TM Fill) will be used for the restoration of class I and II cavities (3 seconds light-curing mode, 3000 milliwatt per square centimeter).
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 according to FDI criteria (grade 1-5)
Time frame: 5 years
| Milestone | Test group (TM Fill in combination with TM Flow) |
|---|---|
| Started | 65 |
| Completed | 64 |
| Not completed | 1 |
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
| Restorations | Test group (TM Fill in combination with TM Flow) |
|---|---|
| FDI Score 1 | 63 |
| FDI Score 2 | 0 |
| FDI Score 3 | 1 |
| FDI Score 4-5 | 0 |
will be assessed according to FDI criteria (grade 1-5)
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 group (TM Fill in combination with TM Flow) | 0/65 (0%) | 0/65 (0%) | 0/65 (0%) |
| Age, Categorical(Participants) | Test group (TM Fill in combination with TM Flow) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 65 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Test group (TM Fill in combination with TM Flow) |
|---|---|
| Female | 27 |
| Male | 38 |
| Race and Ethnicity Not Collected(Participants) | Test group (TM Fill in combination with TM Flow) |
|---|
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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