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Clinical Trials/NCT06212141
NCT06212141Active, not recruitingNot Applicable

Clinical Comparison of Convetional Bulk-Fill Composite Resins and Thermoviscous Bulk-Fill Composite Resins in Class II Restorations

Hacettepe University1 site in 1 country54 target enrollmentStarted: December 12, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
54
Locations
1
Primary Endpoint
Postoperative sensitivity

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

single-blind

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
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

  • •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

Arms & Interventions

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

Intervention: VisCalor Bulk,VOCO,Germany (Device)

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

Intervention: Admira Fusion x-tra,VOCO,Germany (Device)

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

Intervention: Filtek One Bulk,3M,Germany (Device)

Outcomes

Primary Outcomes

Postoperative sensitivity

Time Frame: From baseline to 18 month

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

Marginal Staining

Time Frame: From baseline to 18 month

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

Retention

Time Frame: From baseline to 18 month

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

Marginal Adaptation

Time Frame: From baseline to 18 month

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

Seconder caries

Time Frame: From baseline to 18 month

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Meriç Tuncer

principle investigator

Hacettepe University

Study Sites (1)

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