Clinical Performance of Injectable Composite Resins in Class I Cavities

NCT06192667 | Active Not Recruiting

• 1 other identifier: KA-22112
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Caries,Dental

Keywords

Conventional resin composite; Injectable resin composite; Class I restoration

Outcome Measures

Primary Outcomes (5)

• 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

  From baseline to 24 month

• 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

  From baseline to 24 month

• 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

  From baseline to 24 month

• 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

  From baseline to 24 month

• 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

  From baseline to 24 month

Study Arms (2)

Geanial Injectable Composite Resin

EXPERIMENTAL

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)

3M Filtek Z250 Universal Restorative

EXPERIMENTAL

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)

Interventions

GC Geanial Injectable (Tokyo,Japan) DEVICE

Highly filled composite resin

Geanial Injectable Composite Resin

3M Filtek Z250 Universal Restorative (Germany) DEVICE

Conventional composite resin

3M Filtek Z250 Universal Restorative

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 35068835 BACKGROUND

• 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.

  PMID: 32918395 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Cansu Atalay, Assoc. Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Aslı Ceren Terzi

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Esra Ergin, Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator, Research Assistant

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: June 12, 2023
• Primary Completion: February 15, 2024
• Study Completion (Estimated): August 15, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

TU (1)