Clinical Performance of Injectable Composite Resins in Class I Cavities

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-12

Study Completion Date

2026-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CLINICAL COMPARISON OF DIFFERENT GLASS IONOMER-BASED RESTORATIVES AND A BULK-FILL RESIN COMPOSITE IN CLASS I CAVITIES: A 48-MONTH RANDOMIZED SPLIT-MOUTH CONTROLLED TRIAL

NCT05559333

Class I Dental Caries

COMPLETED NA

Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin

NCT04685967

Tooth Disease

ACTIVE_NOT_RECRUITING NA

Clinical Evaluation of a Restorative Glass Ionomer and a Composite Resin for the Restoration

NCT04266210

Tooth Disease

COMPLETED NA

Clinical Evaluation of Bulk-fill Restorative Materials

NCT06109987

Caries; Dentin

COMPLETED

Clinical Comparison of Resin-hybrid Ceramic Restorations Produced Using a Computer-aided Design/Computer-aided Manufacturing (CAD/CAM) System With Fiber-reinforced Composite Restorations

NCT06496126

Dental Caries

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Caries,Dental

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Geanial Injectable Composite Resin

It 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.

Group Type EXPERIMENTAL

GC Geanial Injectable (Tokyo,Japan)

Intervention Type DEVICE

Highly filled composite resin

3M Filtek Z250 Universal Restorative

It 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.

Group Type EXPERIMENTAL

3M Filtek Z250 Universal Restorative (Germany)

Intervention Type DEVICE

Conventional composite resin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GC Geanial Injectable (Tokyo,Japan)

Highly filled composite resin

Intervention Type DEVICE

3M Filtek Z250 Universal Restorative (Germany)

Conventional composite resin

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes