Comparison of Bulk-Fill Composite Resins in Class II Restorations

NCT06212141 | Active Not Recruiting

• 1 other identifier: KA-22065
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Class II Dental Caries

Keywords

Bulk-Fill Composite; Thermoviscous Bulk-Fill Composite; Class II Restorations

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 an independent clinician. 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 18 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 an independent clinician. Visual inspection with a mirror was performed . Scores: Alfa: No discoloration. Bravo: Discoloration without. Charlie: Discoloration with penetration in pulpal direction

  From baseline to 18 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 an independent clinician. Scores: Alfa: No loss of restorative material. Charlie: Any loss of restorative material

  From baseline to 18 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 an independent clinician. Scores: Alfa: No caries present. Charlie: Caries present

  From baseline to 18 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 an independent clinician. Scores: Alfa: Not present. Bravo: sensitive but diminishing in intensity. . Charlie:constant sensitivity, not diminishing in intensity

  From baseline to 18 month

Study Arms (3)

VisCalor Bulk

ACTIVE COMPARATOR

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

Device: VisCalor Bulk,VOCO,Germany

Admira Fusion x-tra

ACTIVE COMPARATOR

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

Device: Admira Fusion x-tra,VOCO,Germany

Filtek One Bulk

ACTIVE COMPARATOR

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

Device: Filtek One Bulk,3M,Germany

Interventions

VisCalor Bulk,VOCO,Germany 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.

VisCalor Bulk

Admira Fusion x-tra,VOCO,Germany 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.

Admira Fusion x-tra

Filtek One Bulk,3M,Germany 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.

Filtek One Bulk

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 28281590 BACKGROUND

Study Officials

• Nurdan Meserret Başeren, Prof.Dr.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single-blind
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: Randomized split-mouth clinical trial

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: December 12, 2022
• Primary Completion: June 15, 2024
• Study Completion (Estimated): June 15, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

TU (1)