Clinical Performance of Fiber-Reinforced Dentin Replacement Materials

December 27, 2025 updated by: Youness Saleh, Mansoura University

Fiber-Reinforced Versus Bulk-Fill Flowable Resin Composite Dentin Replacement Materials: 4-Year Clinical Performance in Class II Cavities

the current study was conducted to evaluate and compare the flowable short fiber-reinforced (SFRC) and flowable bulk-fill resin composites (BFCs) regarding their 4-year clinical performance as dentin replacement materials in class II cavities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

the current study was conducted to evaluate and compare the flowable short fiber-reinforced (SFRC) and flowable bulk-fill resin composites (BFCs) regarding their 4-year clinical performance as dentin replacement materials in class II cavities. Forty patients were enrolled in the study. Each patient received three class II cavities; one of them was restored with flowable SFRC for dentin replacement, while in the other two cavities, dentin was replaced with two different flowable BFCs. The three dentin replacements were veneered with one particulate filler resin composite (PFC) (Essentia, GC). World Dental Federation (FDI) criteria were used for clinical assessment of the restorations at 1-week (baseline), 6, 12, 18-months, 2, 3, and 4-year intervals.

Study Type

Interventional

Enrollment (Actual)

120

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

  • Egypt
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt, 35516
        • Mansoura 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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • having good oral hygiene.
  • having at least 3 posterior teeth with moderate to large primary proximal carious lesions (score 4 or 5 ICDAS).
  • ranging in age from 20 to 40 years.
  • with normal occlusion.
  • accepting to participate in the study by signing an Arabic-written consent according to the regulations of the Mansoura University Ethical Committee.

Exclusion Criteria:

  • bad oral hygiene.
  • severe chronic periodontitis.
  • having installed orthodontic appliances.
  • abnormal occlusion.
  • parafunctional habits or allergic reaction to any of the materials used in the study.
  • teeth with irreversible pulpitis or non-vital teeth.
  • fractured or cracked teeth. previously restored teeth.
  • teeth with deep sub-gingival cavity margins.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ever x flow short-fiber reinforced composite
Ever x flow was used as dentin replacement material in class II cavities
Other: Ever x flow
Ever x flow was used as dentin replacement material
Other Names:
  • flowable FRC
Experimental: SDR flowable bulk-fill resin composite
SDR was used as dentin replacement material
Other: SDR
SDR was used as dentin replacement material in class II cavities
Experimental: Tetric N-Flow Bulk fill resin composite
Tetric N-Flow Bulk fill was used as dentin replacement material
Other: Tetric N-Flow Bulk fill
Tetric N-Flow Bulk fill was used as dentin replacement material in class II cavities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture of restorative material and restoration retention
Time Frame: four years
Clinical evaluation was performed one week after finishing and polishing (baseline), after 6 months, 1, 2, 3, 4 years using the World Dental Federation (FDI) criteria
four years

Collaborators and Investigators

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

Sponsor

Mansoura 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)

July 1, 2020

Primary Completion (Actual)

August 15, 2024

Study Completion (Actual)

August 15, 2024

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 27, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 27, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A11120520

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no specific reason

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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