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Completed

NCT Number: NCT07320885

Clinical Performance of Fiber-Reinforced Dentin Replacement Materials

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ever x flow

Other

Ever x flow was used as dentin replacement material

Other names: flowable FRC

SDR

Other

SDR was used as dentin replacement material in class II cavities

Tetric N-Flow Bulk fill

Other

Tetric N-Flow Bulk fill was used as dentin replacement material in class II cavities

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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