Clinical Performance of Injectable Composite Resins in Class I Cavities

Caries,Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06192667
• Other study ID #: KA-22112
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: February 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 15, 2024
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

Intervention

Device:
• GC Geanial Injectable (Tokyo,Japan)
Highly filled composite resin
• 3M Filtek Z250 Universal Restorative (Germany)
Conventional composite resin

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

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