Clinical Evaluation of Bulk-fill Composite Resins in Class II Restorations

September 24, 2020 updated by: Nazire Nurdan Çakır, Nuh Naci Yazgan University

Erciyes University Clinical Research Ethics Committee

Composite resins have been widely used in the last years to restore teeth due to increases in patients' esthetic expectations. Therefore optical and mechanical properties of composite resins were being developed day by day. Although there have been many in vitro studies about bulk-fill composite in the literature, the number of clinical trials is insufficient. Therefore, the aim of this study was to evaluate the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental techniques) in Class II carious lesions using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Composite resins have been widely used in the last years to restore teeth due to increases in patients' esthetic expectations. Therefore optical and mechanical properties of composite resins were being developed day by day. Composite resin restorations have the main advantages such as conservative cavity preparation, preserving healthy dental tissue, and strengthening the remaining tooth structure. Furthermore, according to clinical studies, high clinical performance and good longevity have been reported. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique. The incremental technique provides sufficient light penetration and monomer conversion. However, there are many disadvantages to the incremental technique. For instance, bonding failure, blood, or saliva contamination of between layers, the difficulty of application in limited access in small cavities, and to be time-consuming. Because of these, manufacturers have presented a "bulk-fill composites", which could be polymerized in a single layer up to 4-5 mm thick to the market. Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick. Bulk-fill composites that were introduced in recent years can be manipulated faster and more convenient in the cavity compared to conventional hybrid composites. In addition, these materials present good mechanical properties such as marginal adaptation, sealing properties, fracture strength, wear-resistance, and long-term clinical success. Clinical studies are required to clearly describe the clinical behavior of the materials. Although there have been many in vitro studies about bulk-fill composite in the literature, the number of clinical trials is insufficient. Therefore, the aim of this study was to evaluate the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental techniques) in Class II carious lesions using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS)

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey
        • Nuh Naci Yazgan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 4 Class-II caries lesions
  • Good health
  • Acceptable level of oral hygiene

Exclusion Criteria:

  • Did not have four caries lesions at least
  • Did not have Class-II caries lesions
  • Deep caries reaching the pulp
  • The patients are not 18-20 years old
  • Bruxism
  • Periodontal disease
  • Refused to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: X-tra fil (bulk-filling) (X-traB)
X-tra fil composite placed as bulk-filling
Other: Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)

Bulk-fill composites that were introduced in recent years are dental filling materials. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique). Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick.

In this study, each bulk-fill composite resin was used both in bulk-filing and incremental techniques for the same patient. The study set to 4 groups and 20 restorations in each group (a total of 80 restorations).

Other Names:
  • X-tra fil (Voco) bulk-fill composite resin. Filtek Bulk (3M ESPE) bulk-fill composite resin
Active Comparator: X-tra fil (incremental) (X-traI)
X-tra fil composite placed as incremental
Other: Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)

Bulk-fill composites that were introduced in recent years are dental filling materials. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique). Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick.

In this study, each bulk-fill composite resin was used both in bulk-filing and incremental techniques for the same patient. The study set to 4 groups and 20 restorations in each group (a total of 80 restorations).

Other Names:
  • X-tra fil (Voco) bulk-fill composite resin. Filtek Bulk (3M ESPE) bulk-fill composite resin
Active Comparator: Filtek Bulk (bulk-filling) (FBB)
Filtek Bulk composite placed as bulk-filling
Other: Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)

Bulk-fill composites that were introduced in recent years are dental filling materials. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique). Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick.

In this study, each bulk-fill composite resin was used both in bulk-filing and incremental techniques for the same patient. The study set to 4 groups and 20 restorations in each group (a total of 80 restorations).

Other Names:
  • X-tra fil (Voco) bulk-fill composite resin. Filtek Bulk (3M ESPE) bulk-fill composite resin
Active Comparator: Filtek Bulk (incremental) (FBI)
Filtek Bulk composite placed as incremental
Other: Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)

Bulk-fill composites that were introduced in recent years are dental filling materials. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique). Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick.

In this study, each bulk-fill composite resin was used both in bulk-filing and incremental techniques for the same patient. The study set to 4 groups and 20 restorations in each group (a total of 80 restorations).

Other Names:
  • X-tra fil (Voco) bulk-fill composite resin. Filtek Bulk (3M ESPE) bulk-fill composite resin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental) in Class II carious lesions using FDI and USPHS criteria.
Time Frame: Two-year
FDI; The World Dental Federation. USPHS; The United States Public Health Service. The 2-year results of the restorations were evaluated with the FDI and USPHS criteria. Two calibrated observers who were blinded to the objective of this study performed the evaluations.
Two-year
Evaluation of the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental) in Class II carious lesions using FDI and USPHS criteria.
Time Frame: Four-year
FDI; The World Dental Federation. USPHS; The United States Public Health Service. The 4-year results of the restorations were evaluated with the FDI and USPHS criteria. Two calibrated observers who were blinded to the objective of this study performed the evaluations.
Four-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuh Naci Yazgan University

Collaborators

TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (Actual)

September 25, 2020

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015/281

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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