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OpenTrials
Completed

NCT Number: NCT07285772

Clinical Performance of Various Bilayer Biomimetic Resin Composite Strategies

The purpose of this study was to evaluate several bilayer biomimetic composite resin techniques in class I cavities over the course of 18 months in a randomized, double-blind clinical trial.

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Key information

Age range

35 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Restorative Department, Faculty of Dentistry, Tanta University

Tanta, Egypt

About this study

To make resin composite restorations more resistant to cracking in cavities that are under a lot of stress, some have proposed using fiber reinforcement. This proposal is supported by numerous prior investigations that have demonstrated the efficacy of these repairs. By adjusting their orientation, fibers can control the pressures brought on by polymerization shrinkage. Therefore, marginal microleakage has been reduced in comparison to conventional resin composites. One way the material's fibers improve its structural characteristics is by preventing cracks from propagating. Composites are ideal for direct restorations of large cavities in healthy teeth and teeth that have had endodontic treatment because the fiber structure improves their mechanical properties. Moreover, in 2021, a comprehensive analysis of research found that resin composite restorations reinforced with fibers had better adaptability and higher fracture resistance than the standard ones.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Proper oral hygiene
  • Availability for follow-up periods

Exclusion criteria

  • Endodontically treated or non-vital teeth
  • Parafunctional habits such as tooth clenching or grinding

Treatment and study plan

short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite

Other

All patients received four various bilayer biomimetic restorations in four groups (n = 40) as follows: Group I: short fiber reinforced composite (everX Posterior); ); Group II: long fiber reinforced composite (Ribbond Inc., USA); Group III: glass ionomer restorative materials (Riva SDI); and Group IV: flowable composite (G-aenial universal).

Primary outcomes

  1. The primary outcomes are: surface luster, marginal staining, marginal adaptation, fracture, secondary caries, and postoperative sensitivity.

    Time frame: 18 months

    Clinical assessment was carried out according to the World Dental Federation (FDI) by two calibrated evaluators at baseline and at 6, 9, 12, and 18 months. All of the restorations were ranked according to how well they met the criteria: clinically excellent or very satisfactory, clinically satisfactory, clinically satisfactory, or clinically inadequate. Clinical success was defined as a score of 1, 2, or 3, and failure was indicated by scores of 4 or 5. A powerful light source was used to conduct the visual inspection of the parameters. A magnifying dental loupe was utilized for this purpose. The Friedman test was conducted to evaluate intragroup comparisons of the same restoration outcomes through different follow-up periods. The Kruskal-Wallis test was utilized to assess intergroup comparisons between different restorations during the same follow-up period.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

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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