Clinical Performance of Various Bilayer Biomimetic Resin Composite Strategies

December 2, 2025 updated by: Mohammed Abd El Ghany Mohammed, Tanta University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Tanta
      • Tanta, Tanta, Egypt
        • Restorative Department, Faculty of Dentistry, Tanta 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EverX Posterior composite
Short fiber-reinforced composite
Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite
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).
Experimental: Ribbond
Long fiber-reinforced composite
Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite
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).
Experimental: Riva SDI
glass ionomer restorative material
Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite
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).
Experimental: G-aenial universal Flo
flowable composite
Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
18 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • biomimetic resin composite

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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Sponsors and Collaborators

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Drug Interventions

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