Clinical Performance of Injectable Composite Resins in Class I Cavities

November 14, 2025 updated by: Aslı Ceren Terzi, Hacettepe University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: GC Geanial Injectable (Tokyo,Japan)
Highly filled composite resin
Experimental: 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.
Device: 3M Filtek Z250 Universal Restorative (Germany)
Conventional composite resin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal Adaptation
Time Frame: From baseline to 24 month
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
From baseline to 24 month
Marginal Staining
Time Frame: From baseline to 24 month
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
From baseline to 24 month
Retention
Time Frame: From baseline to 24 month
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
From baseline to 24 month
Postoperative sensitivity
Time Frame: From baseline to 24 month
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
From baseline to 24 month
Seconder caries
Time Frame: From baseline to 24 month
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
From baseline to 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Cansu Atalay, Assoc. Prof., Hacettepe University
  • Principal Investigator: Aslı Ceren Terzi, Hacettepe University
  • Principal Investigator: Esra Ergin, Prof., Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2023

Primary Completion (Actual)

February 15, 2024

Study Completion (Estimated)

August 15, 2026

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

December 21, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-22112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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