Non-carious Cervical Lesions
Conditions
Brief summary
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.
Interventions
DEVICERestoration 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.
Sponsors
Ivoclar Vivadent AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Split-Mouth Design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Informed Consent signed by the subject * Age: 18-65 years * 2 NCCL needing treatment, comparable in extend and size, preferably located in different quadrants * Vital teeth, regular sensitivity * Sufficient language skills * No active periodontitis * Preoperative VAS values \< 3 regarding tooth sensitivity on biting. Tooth sensitivity on temperature or touching (tooth brushing, probing) originating in the area of the NCCL is accepted. * Subject wishes to have a restoration as part of the study (written declaration of consent after detailed explanation)
Exclusion criteria
* Not completed hygiene phase or poor oral hygiene * Sufficient isolation of the cavity not possible * Patients with a proven allergy to one of the ingredients (methacrylates) * Patients with severe systemic diseases * Periodontally insufficient dentition * Pregnancy * Part of the development project team of TM Flow * Staff of the study management team * Staff of the internal clinic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Hypersensitivity | 1 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 5 years | will be assessed acooriding to FDI criteria |
Countries
Liechtenstein
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 66 |
| 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. | 66 |
| 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. | 66 |
| 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. | 66 |
| Total | 264 |
Baseline characteristics
| Characteristic | Test goup TM Flow | Control group Tetric EvoFlow | Total |
|---|---|---|---|
| Age, Customized 18 to 65 years | 66 Participants | 66 Participants | 66 Participants |
| Age, Customized <= 18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized > 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex/Gender, Customized Female | 15 Participants | 15 Participants | 15 Participants |
| Sex/Gender, Customized Male | 51 Participants | 51 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 66 |
| other Total, other adverse events | 0 / 66 | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 | 0 / 66 |
Outcome results
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
Time frame: 1 month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test goup TM Flow | Postoperative Hypersensitivity | FDI Score 1 | 66 Teeth |
| Test goup TM Flow | Postoperative Hypersensitivity | FDI Score 2-5 | 0 Teeth |
| Control group Tetric EvoFlow | Postoperative Hypersensitivity | FDI Score 1 | 66 Teeth |
| Control group Tetric EvoFlow | Postoperative Hypersensitivity | FDI Score 2-5 | 0 Teeth |
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
Time frame: 5 years