- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07285772
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
Completed
Conditions
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
Interventional
Enrollment (Actual)
40
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: EverX Posterior composite
Short fiber-reinforced 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
|
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
|
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
|
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
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
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
- Tanner J, Tolvanen M, Garoushi S, Sailynoja E. Clinical Evaluation of Fiber-Reinforced Composite Restorations in Posterior Teeth - Results of 2.5 Year Follow-up. Open Dent J. 2018 Jun 29;12:476-485. doi: 10.2174/1874210601812010476. eCollection 2018.
- ElAziz RH, Mohammed MM, Gomaa HA. Clinical Performance of Short-fiber-reinforced Resin Composite Restorations vs Resin Composite Onlay Restorations in Complex Cavities of Molars (Randomized Clinical Trial). J Contemp Dent Pract. 2020 Mar 1;21(3):296-303.
- Metwaly AA, Elzoghby AF, Abd ElAziz RH. Clinical performance of polyethylenefiber reinforced resin composite restorations in endodontically treated teeth: (a randomized controlled clinical trial). BMC Oral Health. 2024 Oct 24;24(1):1285. doi: 10.1186/s12903-024-05009-8.
- Mohamed MH, Abouauf EA, Mosallam RS. Clinical performance of class II MOD fiber reinforced resin composite restorations: an 18-month randomized controlled clinical trial. BMC Oral Health. 2025 Jan 30;25(1):159. doi: 10.1186/s12903-025-05521-5.
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, 2024
Primary Completion (Actual)
October 10, 2025
Study Completion (Actual)
October 10, 2025
Study Registration Dates
First Submitted
November 22, 2025
First Submitted That Met QC Criteria
December 2, 2025
First Posted (Actual)
December 16, 2025
Study Record Updates
Last Update Posted (Actual)
December 16, 2025
Last Update Submitted That Met QC Criteria
December 2, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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