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Purpose of research: Evaluation and comparison of 24-month clinical performance of injectable and conventional resin composites in class I cavities.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC Geanial Injectable (Tokyo,Japan) | Device | Highly filled composite resin |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cansu Atalay, Assoc. Prof. | Hacettepe University | Principal Investigator |
| Aslı Ceren Terzi | Hacettepe University | Principal Investigator |
| Esra Ergin, Prof. | Hacettepe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University | Ankara | 06100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35068835 | Background | 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. | |
| 32918395 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| 3M Filtek Z250 Universal Restorative (Germany) | Device | Conventional composite resin |
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| From baseline to 24 month |
| 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. |
| 42087142 | Derived | 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. |