Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)NCT06369779

Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment

A study testing TM Fill in combination with TM Flow in people with Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars), run by Ivoclar Vivadent AG at 1 site in Liechtenstein.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)
What is being tested?: TM Fill in combination with TM Flow
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteLiechtenstein
Study dates: 13 May 2024to Dec 2030
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
Indication Class I or II direct restorations in premolars or molars (Replacement of insufficient fillings due to secondary caries, fractures, insufficient marginal adaptation, loss of filling or primary caries)
Cavity width must be at least half of the cusp tip distance
Vital teeth, regular sensitivity
Sufficient language skills
No active periodontits
Preoperative VAS (visual analogue scale) values < 3 regarding tooth sensitivity and biting

Who cannot join

Sufficient isolation of the cavity not possible
Not completed hygiene phase or poor oral hygiene
Missing antagonist, non-occlusion
Missing tooth adjacent to the tooth to be treated
Restorations replacing more than 1 cusp
Caries profunda or very deep cavity

Show all 9Show fewer

Patients with a proven allergy to ingredients of the used materials (methacrylates) or local anesthetics (Articain, sulfite)
Patients with severe systemic diseases
Pregnancy

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 Class I and II Cavities Restored With the Combination of a New Flowable and a New Sculptable Universal Bulk-fill Composite: A Prospective Single Arm Study

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.

Conditions: Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)
Being tested: TM Fill in combination with TM Flow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TM Fill in combination with TM FlowDevice
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).

Study groups in NCT06369779
Study group	Role	What they receive
Test group (TM Fill in combination with TM Flow)	Experimental	TM Fill an TM Flow are used for restoration of class I and class II cavities Receives: Device: TM Fill in combination with TM Flow

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 according to FDI criteria (grade 1-5)
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 2024Dec 2030

First posted17 Apr 2024
Study start13 May 2024
Primary completion12 Aug 2024
Study completionDec 2030 (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 Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)Studies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06369779
Sponsor's protocol ID: OTCS 36406866
Status last verified: Jul 2025
First submitted: 12 Apr 2024
Last updated: 23 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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 Class I and II Cavities Restored With the Combination of a New Flowable and a New Sculptable Universal Bulk-fill Composite: A Prospective Single Arm Study
ClinicalTrials.gov ID: NCT06369779
Acronym / sponsor ID: OTCS 36406866
Conditions: Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 65 participants (actual)
Lead sponsor: Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
Study start: 13 May 2024 (actual)
Primary completion: 12 Aug 2024 (actual)
Study completion: Dec 2030 (estimated)
First posted: 17 Apr 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Test group (TM Fill in combination with TM Flow)	Experimental	Device: TM Fill in combination with TM FlowTM Fill an TM Flow are used for restoration of class I and class II cavities

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
Indication Class I or II direct restorations in premolars or molars (Replacement of insufficient fillings due to secondary caries, fractures, insufficient marginal adaptation, loss of filling or primary caries)
Cavity width must be at least half of the cusp tip distance
Vital teeth, regular sensitivity

Key exclusion criteria (9 listed)

Sufficient isolation of the cavity not possible
Not completed hygiene phase or poor oral hygiene
Missing antagonist, non-occlusion
Missing tooth adjacent to the tooth to be treated
Restorations replacing more than 1 cusp

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
TM Fill in combination with TM FlowThe 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).	Device	Test group (TM Fill in combination with 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

Results posted to the registry on 31 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test group (TM Fill in combination with TM Flow)	65	64

Primary outcome: Postoperative Hypersensitivity

Time frame: 1 month. Number. Unit: Restorations

Measure	Test group (TM Fill in combination with TM Flow) n = 64
FDI Score 1	63
FDI Score 2	0
FDI Score 3	1
FDI Score 4-5	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 Month Recall. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test group (TM Fill in combination with TM Flow)	0 of 65 (0%)	0 of 65 (0%)	0 of 65

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.

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?

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?

On the ClinicalTrials.gov record for NCT06369779.

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.