Tooth DiseasesNCT03556553
Clinical Evaluation of a Self-Adhering Flowable Composite in Class I Cavities
A study testing Vertise Flow, LuxaFlow and Teco Adhesive in people with Tooth Diseases, run by Hacettepe University.
Trial summary
The aim of this study is to evaluate long-term clinical performance of a self-adhering flowable resin composite in comparison with a conventional flowable resin composite used with an etch\&rinse adhesive system in minimally invasive class I cavities. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Diseases
- What is being tested?
- Vertise Flow, LuxaFlow and Teco Adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2011to 30 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- having no medical or behavioral problems preventing then from attending review visits, absence of previously placed restorations,having antagonist teeth
Who cannot join
- poor gingival health,uncontrolled, rampant caries,bruxism,removable partial dentures, xerostomia
About this study
The aim of this study is to evaluate long-term clinical performance of a self-adhering flowable resin composite in comparison with a conventional flowable resin composite used with an etch\&rinse adhesive system in minimally invasive class I cavities. Twenty-five patients will receive at least one pair of class I restorations. After class I cavities were prepared they were restored either with a self-adhering flowable resin composite (VertiseFlow/Kerr-VR) or with a flowable resin composite (Luxaflow/DMG-LX) in combination with an etch\&rinse adhesive (Teco/DMG) [according to the manufacturers' instructions. Restorations will be evaluated at baseline and yearly according to FDI criteria by two evaluaters. Statistical analysis will be carried out with Pearson Chi-Square test and Cochran Q-test followed by Mc Nemar's.
- Conditions
- Tooth Diseases
- Being tested
- Vertise Flow, LuxaFlow, Teco Adhesive
- Keywords
- composite resin, occlusal caries
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertise FlowDevice
Also called Self-adhering flowable composite
Composite resin
LuxaFlowDevice
Also called Flowable composite with Teco adhesive system
Composite resin
Teco AdhesiveDevice
Adhesive system
| Study group | Role | What they receive |
|---|---|---|
| Vertise Flow | Experimental | Superficial Class I cavities restored with Vertise Flow Receives: Device: Vertise Flow |
| LuxaFlow | Experimental | Superficial Class I cavities restored with LuxaFlow Receives: Device: LuxaFlow; Device: Teco Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performances of flowable composite resins
Five year results according to FDIcriteria
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start30 Mar 2011
- Primary completion30 Jun 2011
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiseasesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fatma Dilşad Öz, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556553
- Sponsor's protocol ID
- Vertise-Luxa Flow
- Status last verified
- Sep 2021
- First submitted
- 24 May 2018
- Last updated
- 14 Sep 2021
- Results posted
- No
- 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 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Self-Adhering Flowable Composite in Class I Cavities
- ClinicalTrials.gov ID
- NCT03556553
- Acronym / sponsor ID
- Vertise-Luxa Flow
- Conditions
- Tooth Diseases
- Keywords
- composite resin, occlusal caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Mar 2011 (actual)
- Primary completion
- 30 Jun 2011 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate long-term clinical performance of a self-adhering flowable resin composite in comparison with a conventional flowable resin composite used with an etch\&rinse adhesive system in minimally invasive class I cavities. Twenty-five patients will receive at least one pair of class I restorations. After class I cavities were prepared they were restored either with a self-adhering flowable resin composite (VertiseFlow/Kerr-VR) or with a flowable resin composite (Luxaflow/DMG-LX) in combination with an etch\&rinse adhesive (Teco/DMG) [according to the manufacturers' instructions. Restorations will be evaluated at baseline and yearly according to FDI criteria by two evaluaters. Statistical analysis will be carried out with Pearson Chi-Square test and Cochran Q-test followed by Mc Nemar's.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertise Flow | Experimental | Device: Vertise FlowSuperficial Class I cavities restored with Vertise Flow |
| LuxaFlow | Experimental | Device: LuxaFlow, Device: Teco AdhesiveSuperficial Class I cavities restored with LuxaFlow |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- having no medical or behavioral problems preventing then from attending review visits, absence of previously placed restorations,having antagonist teeth
Key exclusion criteria (1 listed)
- poor gingival health,uncontrolled, rampant caries,bruxism,removable partial dentures, xerostomia
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 |
|---|---|---|
| Vertise FlowAlso: Self-adhering flowable compositeComposite resin | Device | Vertise Flow |
| LuxaFlowAlso: Flowable composite with Teco adhesive systemComposite resin | Device | LuxaFlow |
| Teco AdhesiveAdhesive system | Device | LuxaFlow |
Primary outcome
Clinical performances of flowable composite resins
Time frame: Five years
Five year results according to FDIcriteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Vertise Flow, LuxaFlow and Teco Adhesive in people with Tooth Diseases, run by Hacettepe University.
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 1 inclusion and 1 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 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical performances of flowable composite resins (time frame: Five years). 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 14 Sep 2021.