Non-carious Cervical LesionsNCT06238999
Split-mouth Study of a New Flowable Composite in Non-carious Cervical Lesions
A study testing Restoration of non-carious cervical lesions in people with Non-carious Cervical Lesions, run by Ivoclar Vivadent AG at 1 site in Liechtenstein.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-carious Cervical Lesions
- What is being tested?
- Restoration of non-carious cervical lesions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteLiechtenstein
- Study dates
- 20 Feb 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Part of the development project team of TM Flow
- Staff of the study management team
- Staff of the internal clinic
Trial locations and contacts
1 site in 1 country.
Liechtenstein1 site
Ivoclar Vivadent AG
Schaan, Liechtenstein, 9494
About this study
Official title: Clinical Evaluation of a New Flowable Composite for Direct Restorative Treatment of Non-carious Cervical Lesions: A Prospective Randomized Split-mouth Study
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.
- Conditions
- Non-carious Cervical Lesions
- Being tested
- Restoration of non-carious cervical lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restoration of non-carious cervical lesionsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Restoration of non-carious cervical lesions |
| Control group Tetric EvoFlow | Active comparator | The well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group. Receives: Device: Restoration of non-carious cervical lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (1)
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start20 Feb 2024
- Primary completion30 Apr 2024
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-carious Cervical LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-Mouth Design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivoclar Vivadent AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238999
- Sponsor's protocol ID
- OTCS 36427036
- Status last verified
- Jul 2025
- First submitted
- 26 Jan 2024
- Last updated
- 23 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a New Flowable Composite for Direct Restorative Treatment of Non-carious Cervical Lesions: A Prospective Randomized Split-mouth Study
- ClinicalTrials.gov ID
- NCT06238999
- Acronym / sponsor ID
- OTCS 36427036
- Conditions
- Non-carious Cervical Lesions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Posted 31 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-Mouth Design
| Arm | Type | Receives |
|---|---|---|
| Test goup TM Flow | Experimental | Device: Restoration of non-carious cervical lesionsThe 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. |
| Control group Tetric EvoFlow | Active comparator | Device: Restoration of non-carious cervical lesionsThe well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restoration of non-carious cervical lesionsNon-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. | Device | Control group Tetric EvoFlow, Test goup TM Flow |
Primary outcome
Postoperative Hypersensitivity
Time frame: 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
1 secondary outcome
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
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restoration of non-carious cervical lesions in people with Non-carious Cervical Lesions, run by Ivoclar Vivadent AG at 1 site in Liechtenstein.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Liechtenstein. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Hypersensitivity (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.