CClinicalTrials.gg
Active, not recruitingNCT06212141Updated Nov 18, 2025

Comparison of Bulk-Fill Composite Resins in Class II Restorations

An interventional study of VisCalor Bulk,VOCO,Germany and Admira Fusion x-tra,VOCO,Germany in Class II Dental Caries, sponsored by Hacettepe University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Dec 2022, registered Jan 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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

.

02

Conditions studied

  • Class II Dental Caries

Keywords

  • Bulk-Fill Composite
  • Thermoviscous Bulk-Fill Composite
  • Class II Restorations
03

In context

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    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

    Device: VisCalor Bulk,VOCO,Germany

  • Active comparator
    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

    Device: Admira Fusion x-tra,VOCO,Germany

  • Active comparator
    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

    Device: Filtek One Bulk,3M,Germany

Interventions

  • DeviceVisCalor 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.

  • DeviceAdmira 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.

  • DeviceFiltek 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From baseline to 18 month

  2. 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

    Time frame: From baseline to 18 month

  3. 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

    Time frame: From baseline to 18 month

  4. 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

    Time frame: From baseline to 18 month

  5. 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

    Time frame: From baseline to 18 month

07

Study locations

1 site
  • Hacettepe University
    Ankara, Ankara 06100, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 28281590 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06212141
Lead sponsor
Hacettepe University
Responsible party
Meriç Tuncer (principle investigator, Hacettepe University) — Principal investigator
First posted
Jan 18, 2024
Start date
Dec 12, 2022
Primary completion
Jun 15, 2024
Completion
Jun 15, 2026 (estimated)
Last update
Nov 18, 2025

Study contacts

Nurdan Meserret Başeren, Prof.Dr.
principal investigator · Hacettepe University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion