Dental CariesNCT03221660
Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy
A study testing F-Composite 2 system in people with Dental Caries and Unsatisfactory or Defective Restoration of Tooth, run by Ivoclar Vivadent AG at 1 site in Liechtenstein.
Trial summary
The objective of this study is to evaluate the clinical performance of F-Composite 2 system in Class I and Class II cavities in permanent teeth. The materials of the system can be polymerized in short time with a curing light which is part of the system. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dental Caries, Unsatisfactory or Defective Restoration of Tooth
- What is being tested?
- F-Composite 2 system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteLiechtenstein
- Study dates
- 11 Jan 2018to 7 Jul 2023
- 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
- Indication for direct filling of Class I or II with permanent premolars or permanent molars
- replacement of insufficient fillings (e.g., due to edge caries, filling fracture, Lack of quality of the surface, lack of aesthetics, undesirable filling material, leaky edge, edge gap, etc.)
- extensive primary caries
- Vital tooth (cold test)
- One-, two- or three-surface fillings in the lateral tooth area, with a maximum of 25% single-faced (Class I) with antagonists.
- The occlusal area of the filling must be at least 1/3 of the total area of the filling tooth. This criterion is estimated.
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- Patient wishes to receive care within the framework of the study (written consent after detailed elucidation and study of patient information).
- Maximum of 2 restorations per patient.
- Preoperative complaints on the tooth to be restored (maximum 3 on visual Analog scale (0 = complaint-free, 10 = maximum possible pain) to temperature or bite sensitivity
- Sufficient language skills
Who cannot join
- Unfinished hygiene phase or poor oral hygiene
- Sufficient draining of the operating field is not possible
- Patients with proven allergy to one of the ingredients of the materials used
- Patient has allergies to local anesthetic agents Ultracain DS (active substance: articaine; Vasoconstrictor), if anesthesia is desired
- Patients with severe systemic diseases
- Devital or pulpitic teeth
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- Periodontal insufficiency
- Supplements with cusp attachments
- open side bite
- missing antagonist
- Indication for direct capping
- Pregnancy (women of childbearing age receive a free pregnancy test for self application, the negative result of which is shown with her confirmed consent).
Trial locations and contacts
1 site in 1 country.
Liechtenstein1 site
Ivoclar Vivadent
Schaan, 9494
About this study
The objective of this study is to evaluate the clinical performance of F-Composite 2 system in Class I and Class II cavities in permanent teeth.
The materials of the system can be polymerized in short time with a curing light which is part of the system.
The study will be carried out as a prospective study, with evaluation of the restorations after 7-10 days (baseline), at 6 months, at 12 months, at 24 months and 60 months according to defined criteria.
- Being tested
- F-Composite 2 system
- Keywords
- filling material, polymerization
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-Composite 2 systemDevice
Procedures will be done using local anesthesia (if the patients wants that). The cavity is prepared according to the principles of the adhesive technique. First the adhesive will be applied and polymerized, afterwards the flowable resin-based restorative material will be applied and polymerized and then the sculptable resin-based restorative material will be applied and polymerized; all materials will be light-cured within short time with an experimental curing light.
| Study group | Role | What they receive |
|---|---|---|
| F-Composite 2 system | Experimental | Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the F-Composite 2 system. Receives: Device: F-Composite 2 system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Restored Teeth With Postoperative Sensitivity
The postoperative sensitivity is assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, from 0 "no pain" to 10 "maximum pain") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable".
A maximum of 10% postoperative hypersensitivities are defined as acceptable after one month.
Measured: 1 month
Secondary outcomes (2)
Number of Restored Teeth With Loss of Vitality
The loss of vitality of restored teeth is assessed by a cold stimuli test (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable".
A maximum of 1 tooth with loss of vitality within 12 months is determined to be acceptable.
Measured: 12 months
Replacement of Filling
maximum of 3 fillings which have to be replaced due to a lack of quality after 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start11 Jan 2018
- Primary completion3 Apr 2018
- Study completion7 Jul 2023
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 Dental CariesStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivoclar Vivadent AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lukas Enggist, Dr, Principal investigator, dentist internal clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221660
- Sponsor's protocol ID
- 621211
- Status last verified
- Mar 2025
- First submitted
- 13 Jul 2017
- Last updated
- 13 Apr 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 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy
- ClinicalTrials.gov ID
- NCT03221660
- Acronym / sponsor ID
- 621211
- Keywords
- filling material, polymerization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Posted 16 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the clinical performance of F-Composite 2 system in Class I and Class II cavities in permanent teeth.
The materials of the system can be polymerized in short time with a curing light which is part of the system.
The study will be carried out as a prospective study, with evaluation of the restorations after 7-10 days (baseline), at 6 months, at 12 months, at 24 months and 60 months according to defined criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F-Composite 2 system | Experimental | Device: F-Composite 2 systemTooth (teeth) affected by dental caries or with an existing defective filling will be restored using the F-Composite 2 system. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Indication for direct filling of Class I or II with permanent premolars or permanent molars
- replacement of insufficient fillings (e.g., due to edge caries, filling fracture, Lack of quality of the surface, lack of aesthetics, undesirable filling material, leaky edge, edge gap, etc.)
- extensive primary caries
- Vital tooth (cold test)
- One-, two- or three-surface fillings in the lateral tooth area, with a maximum of 25% single-faced (Class I) with antagonists.
Key exclusion criteria (12 listed)
- Unfinished hygiene phase or poor oral hygiene
- Sufficient draining of the operating field is not possible
- Patients with proven allergy to one of the ingredients of the materials used
- Patient has allergies to local anesthetic agents Ultracain DS (active substance: articaine; Vasoconstrictor), if anesthesia is desired
- Patients with severe systemic diseases
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 |
|---|---|---|
| F-Composite 2 systemProcedures will be done using local anesthesia (if the patients wants that). The cavity is prepared according to the principles of the adhesive technique. First the adhesive will be applied and polymerized, afterwards the flowable resin-based restorative material will be applied and polymerized and then the sculptable resin-based restorative material will be applied and polymerized; all materials will be light-cured within short time with an experimental curing light. | Device | F-Composite 2 system |
Primary outcome
Percentage of Restored Teeth With Postoperative Sensitivity
Time frame: 1 month
The postoperative sensitivity is assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, from 0 "no pain" to 10 "maximum pain") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable". A maximum of 10% postoperative hypersensitivities are defined as acceptable after one month.
2 secondary outcomes
Number of Restored Teeth With Loss of Vitality
Time frame: 12 months
Replacement of Filling
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lukas Enggist, Dr principal investigator
dentist internal clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-Composite 2 system in people with Dental Caries and Unsatisfactory or Defective Restoration of Tooth, 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 10 inclusion and 12 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: finished, as of the sponsor's last update on 13 Apr 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 16 Dec 2020). 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?
Percentage of Restored Teeth With Postoperative Sensitivity (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 13 Apr 2025.