Comparison of Bulk-Fill Composite Resins in Class II Restorations

NCT ID: NCT06212141

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-12
• Study Completion Date: 2026-06-15

Brief Summary

The goal of this clinical trial is to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins .

Class II restorations will be performed in patients using three different restorative materials.And restorations will be evaluated using modified US Public Health Service criteria Resorations will be photograped and restorations will be evaluated for 6,12 months.

Detailed Description

The aim of this clinical study was to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins.

Methods and Materials: Class II restorations will be performed in patients using three different restorative materials: VisCalor Thermoviscous Bulk-Fill (VCB; a thermoviscous nanohybrid bulk-fill composite resin) , Admira Fusion x-tra ( AFT: a conventional nanohybrid bulk-fill composite resin) and 3M Filtek One Bulk-Fill Restprative (FOB: a conventional bulk-fill nanocomposite ) Futura Bond U adhesive will be used for both conventional bulk-fill composite resin restorations and thermoviscous bulk-fill composite resin restorations.

Criteria for inclusion of patients in the study : Healthy individuals without any systemic disease, patients who is between 18 and 60 years old, patiens who brush their teeth 2 times a day,voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment.

Criteria for not inclusion of volunteers in research:Women who are pregnant or breastfeeding ,patienrs with advanced periodontial disease,patiens using a moving segmental prosthesis,patiens who have maloclusions,patiens who have bruxism,patients with known allergies to resin-based restorative materials and binding agents

The restorations will be evaluated using modified US Public Health Service criteria in terms of retention, color match, marginal discoloration, anatomic form, marginal adaptation, secondary caries, postoperative sensitivity, and surface texture. Resorations will be photograped and restorations will be evaluated for 6,12 months

.

Conditions

Class II Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VisCalor Bulk

Thermoviscous Bulkfill composite resin Warming of the material makes it flowable for the application and then sculptable immediately afterwards (thermoviscous technology) Optimal flowing to margins and undercut regions One universal and three aesthetic shades Cannula form

Group Type: ACTIVE_COMPARATOR

VisCalor Bulk,VOCO,Germany

Intervention Type: DEVICE

It was placed class II restorations.Before applying it, a 37% orthophosphoric acid will be injected into the cavity for 30 sec. on the enamel and 15 sec. on the dentin. Then, cavity will be rinsed with pressurized air and water for 15 sec. and Futura Bond U adhesive agent will be applied to the enamel and dentin surfaces using a disposable applicator for 20 sec. Then light air pressure will be applied for 5 sec., and then polymerization will be carried out for 10 sec. using LED light.

When it comes to the application of VisCalor , the VisCalor Gun , heating device will be used. A disposable composite capsule will be placed into the device, and it will be heated by selecting program 1 (65°C) for 30 sec. The material will remain hot for 2.5 min.

The nozzle of the capsule on the gun will be directly applied to the deepest part of the cavity, ensuring that the material is placed from bottom to top without exceeding 4 mm. Polymerization will be carried out with LED for 10 sec.

Admira Fusion x-tra

Ormocer based bulkfill composite Purely ceramic-based, bulk fill restorative material Reliable curing of 4 mm layersby far the lowest polymerisation shrinkage (1.25 % by volume) and particularly low level of shrinkage stress, providing optimal marginal integrity.

inert, so excellent biocompatible and extremely resistant to discolouration Easy handling, simple high-lustre polishing procedure coupled with high surface hardness guarantee first-class long-term results Universal shade with chameleon effect

Group Type: ACTIVE_COMPARATOR

Admira Fusion x-tra,VOCO,Germany

Intervention Type: DEVICE

Admira Fusion x-tra composite resin was placed class II restorations. Before applying it an orthophosphoric acid with a concentration of 37% will be injected into the cavity for 30 sec. on the enamel and 15 sec. on the dentin. Then, cavity will be rinsed with pressurized air and water for 20 sec. And Futura Bond U adhesive agent will be applied to the enamel and dentin surfaces using a disposable applicator for 20 sec. Following the manufacturer's recommendations, light air pressure will be applied for 5 sec, and then polymerization will be carried out for 10 sec. using LED light with a power of 1200 mW/cm².

Afterwards bulk-fill composite will be placed in the cavity, ensuring that each layer does not exceed 4 mm, and appropriate occlusal shaping will be performed. Polymerization will be carried out with LED light for 20 seconds.

Filtek One Bulk

Conventional bulkfill compositeFocused options powered by 3M technology help you complete posterior restorations in a single bulk placement.

5 shades avaible : A1, A2, A3, B1, and C2. Excellent adaptation and sculptability for fast, easy placement. One-step placement : Tackle deep cavities with up to 5 mm depth of cure

Group Type: ACTIVE_COMPARATOR

Filtek One Bulk,3M,Germany

Intervention Type: DEVICE

Filtek One Bulk composite resin was placed class II restorations. Before applyingthe material, a 37% orthophosphoric acid will be injected into the cavity for 30 sec. on the enamel and 15 sec. on the dentin, followed by rinsing the cavity with pressurized air and water for 20 sec.Then , adhesive agent will be applied to the enamel and dentin surfaces using a disposable applicator for 20 sec. Following the manufacturer's recommendations, light air pressure will be applied for 5 sec, and then polymerization will be carried out for 10 sec using LED light .

Afterwards, bulk-fill composite will be placed in the cavity, ensuring that each layer does not exceed 4 mm, and appropriate occlusal shaping will be performed. Polymerization will be carried out with LED light at a power of 1200 mW/cm² for 10 sec from all directions, following the manufacturer's recommendations.

Interventions

VisCalor Bulk,VOCO,Germany

It was placed class II restorations.Before applying it, a 37% orthophosphoric acid will be injected into the cavity for 30 sec. on the enamel and 15 sec. on the dentin. Then, cavity will be rinsed with pressurized air and water for 15 sec. and Futura Bond U adhesive agent will be applied to the enamel and dentin surfaces using a disposable applicator for 20 sec. Then light air pressure will be applied for 5 sec., and then polymerization will be carried out for 10 sec. using LED light.

When it comes to the application of VisCalor , the VisCalor Gun , heating device will be used. A disposable composite capsule will be placed into the device, and it will be heated by selecting program 1 (65°C) for 30 sec. The material will remain hot for 2.5 min.

The nozzle of the capsule on the gun will be directly applied to the deepest part of the cavity, ensuring that the material is placed from bottom to top without exceeding 4 mm. Polymerization will be carried out with LED for 10 sec.

Intervention Type: DEVICE

Admira Fusion x-tra,VOCO,Germany

Admira Fusion x-tra composite resin was placed class II restorations. Before applying it an orthophosphoric acid with a concentration of 37% will be injected into the cavity for 30 sec. on the enamel and 15 sec. on the dentin. Then, cavity will be rinsed with pressurized air and water for 20 sec. And Futura Bond U adhesive agent will be applied to the enamel and dentin surfaces using a disposable applicator for 20 sec. Following the manufacturer's recommendations, light air pressure will be applied for 5 sec, and then polymerization will be carried out for 10 sec. using LED light with a power of 1200 mW/cm².

Afterwards bulk-fill composite will be placed in the cavity, ensuring that each layer does not exceed 4 mm, and appropriate occlusal shaping will be performed. Polymerization will be carried out with LED light for 20 seconds.

Intervention Type: DEVICE

Filtek One Bulk,3M,Germany

Filtek One Bulk composite resin was placed class II restorations. Before applyingthe material, a 37% orthophosphoric acid will be injected into the cavity for 30 sec. on the enamel and 15 sec. on the dentin, followed by rinsing the cavity with pressurized air and water for 20 sec.Then , adhesive agent will be applied to the enamel and dentin surfaces using a disposable applicator for 20 sec. Following the manufacturer's recommendations, light air pressure will be applied for 5 sec, and then polymerization will be carried out for 10 sec using LED light .

Afterwards, bulk-fill composite will be placed in the cavity, ensuring that each layer does not exceed 4 mm, and appropriate occlusal shaping will be performed. Polymerization will be carried out with LED light at a power of 1200 mW/cm² for 10 sec from all directions, following the manufacturer's recommendations.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy individuals without any systemic disease
• Patients who is between 18 and 60 years old,
• Patiens who brush their teeth 2 times a day
• Voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment.

Exclusion Criteria

• Women who are pregnant or breastfeeding
• Patients with advanced periodontial disease
• Patiens using a moving segmental prosthesis
• Patiens who have maloclusions,
• Patiens who have bruxism,
• Patients with known allergies to resin-based restorative materials and binding agents

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Meriç Tuncer

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nurdan Meserret Başeren, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Hacettepe University

Ankara, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Chesterman J, Jowett A, Gallacher A, Nixon P. Bulk-fill resin-based composite restorative materials: a review. Br Dent J. 2017 Mar 10;222(5):337-344. doi: 10.1038/sj.bdj.2017.214.

Reference Type: BACKGROUND

PMID: 28281590 (View on PubMed)

Other Identifiers

KA-22065

Identifier Type: -

Identifier Source: org_study_id