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Active, Not Recruiting

NCT Number: NCT06192667

Clinical Performance of Injectable Composite Resins 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Caries,Dental Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GC Geanial Injectable (Tokyo,Japan)

Device

Highly filled composite resin

3M Filtek Z250 Universal Restorative (Germany)

Device

Conventional composite resin

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jan 5, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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