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Caries,DentalNCT06192667

Clinical Performance of Injectable Composite Resins in Class I Cavities

A study testing GC Geanial Injectable (Tokyo,Japan) and 3M Filtek Z250 Universal Restorative (Germany) in people with Caries,Dental, run by Hacettepe University at 1 site in Turkey (Türkiye).

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

Purpose of research: Evaluation and comparison of 24-month clinical performance of injectable and conventional resin composites in class I cavities. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Caries,Dental
What is being tested?
GC Geanial Injectable (Tokyo,Japan) and 3M Filtek Z250 Universal Restorative (Germany)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
12 Jun 2023to 15 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy individuals who do not have any systemic disease that prevents restorative treatment
  • Individuals between the ages of 18-35
  • Brushing your teeth twice a day
  • Having at least 20 teeth in occlusion and at least 2 occlusal lesions with antagonist teeth in the opposite arch
  • Volunteer individuals who agree to participate in the research and sign the informed consent form and who have undergone initial periodontal treatment will be included in the study.

Who cannot join

  • Pregnant or breastfeeding women
  • Individuals with advanced periodontal disease
  • Individuals using removable partial dentures
  • Individuals with bruxism
  • Individuals with malocclusion
  • Patients with known allergies to resin-based restorative materials and bonding agents
  • Patients with a history of allergy to local anesthesia
  • Endodontic treatment, teeth that need pulp capping or endodontic treatment is available

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Hacettepe University

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: 24- Month Clinical Performance of Injectable and Conventional Resin Composites in Class I Cavities

Purpose of research: Evaluation and comparison of 24-month clinical performance of injectable and conventional resin composites in class I cavities.

Read the detailed description

The mechanical properties of conventional resin composites have been tried to be improved. In addition to the developed mechanical properties, the need for easy and fast application led to the development of flowable composites. Flowable composites have lower filler ratio than conventional hybrid composites so they are less rigid and have lower modulus of elasticity. For these reasons, the use of flowable composites in areas that may be exposed to high forces, especially occlusal cavities, is not recommended. Today, it is aimed to increase the wear resistance by increasing the amount of filler in flowable composites and producing injectable composites. A new product recently introduced to the market, a high-strength nano-filled injectable composite material, GC's G-ænial Universal Injectable(Tokyo,Japan), was also included in the study. This is a low-viscosity composite in which modifications have been made to provide a product with high wear resistance and depth of cure to make it suitable for posterior restorations.

One lesion in each patient will be randomly assigned to be restored using either the G-aenial Universal Injectable or Filtek Z250 resin composites. The adhesive, G2-BOND Universal will be used for adhesive procedures. The clinical procedure for the restorations will be performed by a single operator. The restorations will be evaluated by two calibrated examiners at baseline and at 6, 12, 18, 24 months in accordance with the modified USPHS criteria. Data will be statistically analyzed using the Chi-square and Cochran Q tests (p < 0.05).

Conditions
Caries,Dental
Being tested
GC Geanial Injectable (Tokyo,Japan), 3M Filtek Z250 Universal Restorative (Germany)
Keywords
Conventional resin composite, Injectable resin composite, Class I restoration
Medical subject headings
Dental Caries

What participants receive

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

  • GC Geanial Injectable (Tokyo,Japan)Device

    Highly filled composite resin

  • 3M Filtek Z250 Universal Restorative (Germany)Device

    Conventional composite resin

Study groups in NCT06192667
Study groupRoleWhat they receive
Geanial Injectable Composite ResinExperimentalIt contains 31% methacrylate monomer in the resin matrix and 69% silica and barium glass as fillers. A1, A2, A3, A3.5, A4, B1, B2, B3, C3, CV, BW, AO2, AO3, JE, AE colors are available. Due to their high durability, they can be used in places where recyclable composite resins are used. Apart from this, they are used as fissure sealants, sealants, repair of indirect restorations, blocking of undercuts and liner, like flowable composites. After completing the cavity, the enamel surface was selectively roughened using 37% orthophosphoric acid for 15 seconds. Subsequently, G2 Bond Universal adhesive agent (GC Corp., Tokyo, Japan) was utilized. It was applied in 2mm layers in accordance with the composite manufacturer's instructions. Each layer was polymerized for 20 seconds.
Receives: Device: GC Geanial Injectable (Tokyo,Japan)
3M Filtek Z250 Universal RestorativeExperimentalIt is designed to be used in both anterior and posterior restorations. The filler in the Filtek Z250 restorative is zirconia/silica. The inorganic filler is 60 vol% (without silane treatment) with a particle size of 0.01 to 3.5 μm. Filtek Z250 restorative contains BIS-GMA, UDMA and BIS-EMA monomers. Various restorative color options are available. It is packaged in conventional syringes and single-dose capsules. After completing the cavity, the enamel surface was selectively roughened using 37% orthophosphoric acid for 15 seconds. Subsequently, G2 Bond Universal adhesive agent (GC Corp., Tokyo, Japan) was utilized. It was applied in 2mm layers in accordance with the composite manufacturer's instructions. Each layer was polymerized for 20 seconds.
Receives: Device: 3M Filtek Z250 Universal Restorative (Germany)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Marginal Adaptation

    Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed

    Measured: From baseline to 24 month

  2. Marginal Staining

    Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal staining. Marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores: Alfa: No discoloration. Bravo: Discoloration without. Charlie: Discoloration with penetration in pulpal direction

    Measured: From baseline to 24 month

  3. Retention

    Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No loss of restorative material. Charlie: Any loss of restorative material

    Measured: From baseline to 24 month

  4. Postoperative sensitivity

    Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: Not present. Bravo: sensitive but diminishing in intensity. Charlie:constant sensitivity, not diminishing in intensity

    Measured: From baseline to 24 month

  5. Seconder caries

    Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No caries present. Charlie: Caries present

    Measured: From baseline to 24 month

Timeline

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

  1. First posted5 Jan 2024
  2. Study start12 Jun 2023
  3. Primary completion15 Feb 2024
  4. Study completion15 Aug 2026 (estimated)

Resources

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
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06192667
Sponsor's protocol ID
KA-22112
Status last verified
Nov 2025
First submitted
21 Dec 2023
Last updated
18 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Shaalan OO, Abou-Auf E. A 24-Month Evaluation of Self-Adhering Flowable Composite Compared to Conventional Flowable Composite in Conservative Simple Occlusal Restorations: A Randomized Clinical Trial. Contemp Clin Dent. 2021 Oct-Dec;12(4):368-375. doi: 10.4103/ccd.ccd_600_20. Epub 2021 Dec 21.

    PubMed 35068835

  • Ypei Gia NR, Sampaio CS, Higashi C, Sakamoto A Jr, Hirata R. The injectable resin composite restorative technique: A case report. J Esthet Restor Dent. 2021 Apr;33(3):404-414. doi: 10.1111/jerd.12650. Epub 2020 Sep 11.

    PubMed 32918395

  • Kubilay AC, Atalay C, Ergin E. Short-term clinical and micromorphological comparison of injectable and paste composites in occlusal cavities. BMC Oral Health. 2026 May 5;26(1):880. doi: 10.1186/s12903-026-08472-7.

    PubMed 42087142

Questions about this trial

What is this clinical trial studying?

A study testing GC Geanial Injectable (Tokyo,Japan) and 3M Filtek Z250 Universal Restorative (Germany) in people with Caries,Dental, run by Hacettepe 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 5 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: under way, not looking for participants, as of the sponsor's last update on 18 Nov 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 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?

This study is still under way. Results are not available in the source record yet.

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?

Marginal Adaptation (time frame: From baseline to 24 month). The study lists 5 primary outcomes in all. 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 NCT06192667, which also lists 3 linked publications.

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 18 Nov 2025.

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