Dental CariesNCT06346795
Class II Restorations With High-Filled Flowable Composites
A study testing High-filling flowable dental composite in people with Dental Caries and Class II Dental Caries, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
In the study, Class II restorations will be performed with G-aenial Universal Injectable (GC/ Tokyo, Japan), Grandio Flow (VOCO/ Germany), and Clearfil Majesty Flow (Kuraray/ Japan) composites will evaluated. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Class II Dental Caries
- What is being tested?
- High-filling flowable dental composite
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Jun 2025
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A patient presenting with;
- over 18 years of age
- a normal periodontal status and good general health
- proximal caries that are similar in size to premolar and molar teeth
- vital teeth
- teeth in contact with the opposing tooth and subjected to normal occlusal forces
- attend follow-up appointments
Who cannot join
- poor oral hygiene status
- those with severe or chronic periodontitis
- absence of adjacent and antagonist teeth
- potential behavioral problems (e.g. bruxism)
- allergy to any product used in the study
- exposure of the pulp during cavity preparation
- systemically unhealthy
- pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, Faculty of Dentistry, Restorative Dentistry Department
Konya
About this study
Official title: Clinical Evaluation of Class II Restorations Made With Highly Filled Flowable Composite Resins
In the study, Class II restorations will be performed with G-aenial Universal Injectable (GC/ Tokyo, Japan), Grandio Flow (VOCO/ Germany), and Clearfil Majesty Flow (Kuraray/ Japan) composites will evaluated. Restorations will be assessed according to modified USPHS criteria in 1st week, 6th months, and 12th months from the placement date. The Chi-square test will used for statistical analysis of the difference between the groups, and the Cochran Q test will used for the significance of the difference between time-dependent changes within each group (p<0.05).
- Conditions
- Dental Caries, Class II Dental Caries
- Being tested
- High-filling flowable dental composite
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-filling flowable dental compositeOther
Class II restorations will be performed with G-aenial Universal Injectable, Grandio Flow, and Clearfil Majesty Flow high-filling flowable composites.
| Study group | Role | What they receive |
|---|---|---|
| G-aenial Universal Injectable | Experimental | Not described Receives: Other: High-filling flowable dental composite |
| Grandio Flow | Experimental | Not described Receives: Other: High-filling flowable dental composite |
| Clearfil Majesty Flow | Experimental | Not described Receives: Other: High-filling flowable dental composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
No loss of restorative material
Measured: 7th day, 6th month, 12th month.
Color match
The restoration matches the adjacent tooth structure in color and translucency
Measured: 7th day, 6th month, 12th month.
Marginal discoloration
There is no discoloration anywhere on the margin between the restoration and the tooth structure
Measured: 7th day, 6th month, 12th month.
Marginal adaptation
There is no visible evidence of a crevice along the margin into which the explorer will penetrate
Measured: 7th day, 6th month, 12th month.
Secondary caries
No evidence of secondary caries
Measured: 7th day, 6th month, 12th month.
Surface texture
The surface of the restoration does not have any defects
Measured: 7th day, 6th month, 12th month.
Anatomical form
The restoration is continuous with the existing anatomic form
Measured: 7th day, 6th month, 12th month.
Postoperative sensitivity
No postoperative sensitivity, after the restorative procedure and during the study
Measured: 7th day, 6th month, 12th month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Gurses, Selcuk University
- Investigators
- Merve Gürses, Principal investigator, Selcuk University, Faculty of Dentistry, Department of Restorative Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346795
- Sponsor's protocol ID
- SelcukC
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 25 Apr 2024
- Results posted
- 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 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Class II Restorations Made With Highly Filled Flowable Composite Resins
- ClinicalTrials.gov ID
- NCT06346795
- Acronym / sponsor ID
- SelcukC
- Conditions
- Dental Caries, Class II Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 4 Apr 2024 (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.
In the study, Class II restorations will be performed with G-aenial Universal Injectable (GC/ Tokyo, Japan), Grandio Flow (VOCO/ Germany), and Clearfil Majesty Flow (Kuraray/ Japan) composites will evaluated. Restorations will be assessed according to modified USPHS criteria in 1st week, 6th months, and 12th months from the placement date. The Chi-square test will used for statistical analysis of the difference between the groups, and the Cochran Q test will used for the significance of the difference between time-dependent changes within each group (p<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G-aenial Universal Injectable | Experimental | Other: High-filling flowable dental composite |
| Grandio Flow | Experimental | Other: High-filling flowable dental composite |
| Clearfil Majesty Flow | Experimental | Other: High-filling flowable dental composite |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- A patient presenting with;
- over 18 years of age
- a normal periodontal status and good general health
- proximal caries that are similar in size to premolar and molar teeth
- vital teeth
Key exclusion criteria (8 listed)
- poor oral hygiene status
- those with severe or chronic periodontitis
- absence of adjacent and antagonist teeth
- potential behavioral problems (e.g. bruxism)
- allergy to any product used in the study
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 |
|---|---|---|
| High-filling flowable dental compositeClass II restorations will be performed with G-aenial Universal Injectable, Grandio Flow, and Clearfil Majesty Flow high-filling flowable composites. | Other | Clearfil Majesty Flow, G-aenial Universal Injectable, Grandio Flow |
Primary outcome
Retention
Time frame: 7th day, 6th month, 12th month.
No loss of restorative material
Color match
Time frame: 7th day, 6th month, 12th month.
The restoration matches the adjacent tooth structure in color and translucency
Marginal discoloration
Time frame: 7th day, 6th month, 12th month.
There is no discoloration anywhere on the margin between the restoration and the tooth structure
Marginal adaptation
Time frame: 7th day, 6th month, 12th month.
There is no visible evidence of a crevice along the margin into which the explorer will penetrate
Secondary caries
Time frame: 7th day, 6th month, 12th month.
No evidence of secondary caries
Surface texture
Time frame: 7th day, 6th month, 12th month.
The surface of the restoration does not have any defects
Anatomical form
Time frame: 7th day, 6th month, 12th month.
The restoration is continuous with the existing anatomic form
Postoperative sensitivity
Time frame: 7th day, 6th month, 12th month.
No postoperative sensitivity, after the restorative procedure and during the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- 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.
Merve Gürses principal investigator
Selcuk University, Faculty of Dentistry, Department of Restorative Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-filling flowable dental composite in people with Dental Caries and Class II Dental Caries, run by Selcuk University at 1 site in Turkey (Türkiye).
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Apr 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MERVE GÜRSES (+905313747997, merve.gurses@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: 7th day, 6th month, 12th month.). The study lists 8 primary outcomes in all. 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 25 Apr 2024.