Composite RestorationNCT07285772
Clinical Performance of Various Bilayer Biomimetic Resin Composite Strategies
A study testing short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite in people with Composite Restoration and Composites Resins, run by Tanta University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 45 years
- Conditions the study is for
- Composite Restoration, Composites Resins
- What is being tested?
- short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Proper oral hygiene
- Availability for follow-up periods
Who cannot join
- Endodontically treated or non-vital teeth
- Parafunctional habits such as tooth clenching or grinding
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Restorative Department, Faculty of Dentistry, Tanta University
Tanta, Tanta
About this study
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.
Read the 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.
- Conditions
- Composite Restoration, Composites Resins
- Being tested
- short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite
- Keywords
- Clinical, Biomimetic, Composite, Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable compositeOther
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).
| Study group | Role | What they receive |
|---|---|---|
| EverX Posterior composite | Experimental | Short fiber-reinforced composite Receives: Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite |
| Ribbond | Experimental | Long fiber-reinforced composite Receives: Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite |
| Riva SDI | Experimental | glass ionomer restorative material Receives: Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite |
| G-aenial universal Flo | Experimental | flowable composite Receives: Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes are: surface luster, marginal staining, marginal adaptation, fracture, secondary caries, and postoperative sensitivity.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Jan 2024
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Composite RestorationStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abd El Ghany Mohammed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285772
- Sponsor's protocol ID
- biomimetic resin composite
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30069257ElAziz 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.
PubMed 32434978Metwaly 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.
PubMed 39448991Mohamed 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.
PubMed 39881262Mohammed MAEG, Hassan MA, Morsy KES. Clinical evaluation of different bi-layer biomimetic strategies of composite resin in large class I cavities: an 18-month randomized clinical trial. BMC Oral Health. 2026 May 1;26(1):862. doi: 10.1186/s12903-026-08403-6.
PubMed 42067824
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Various Bilayer Biomimetic Resin Composite Strategies
- ClinicalTrials.gov ID
- NCT07285772
- Acronym / sponsor ID
- biomimetic resin composite
- Conditions
- Composite Restoration, Composites Resins
- Keywords
- Clinical, Biomimetic, Composite, Class I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EverX Posterior composite | Experimental | Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable compositeShort fiber-reinforced composite |
| Ribbond | Experimental | Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable compositeLong fiber-reinforced composite |
| Riva SDI | Experimental | Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable compositeglass ionomer restorative material |
| G-aenial universal Flo | Experimental | Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable compositeflowable composite |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Proper oral hygiene
- Availability for follow-up periods
Key exclusion criteria (2 listed)
- Endodontically treated or non-vital teeth
- Parafunctional habits such as tooth clenching or grinding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable compositeAll 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). | Other | EverX Posterior composite, G-aenial universal Flo, Ribbond, Riva SDI |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 30069257Tanner 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.
- Background: PubMed 32434978ElAziz 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.
- Background: PubMed 39448991Metwaly 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.
- Background: PubMed 39881262Mohamed 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.
- Derived from this study: PubMed 42067824Mohammed MAEG, Hassan MA, Morsy KES. Clinical evaluation of different bi-layer biomimetic strategies of composite resin in large class I cavities: an 18-month randomized clinical trial. BMC Oral Health. 2026 May 1;26(1):862. doi: 10.1186/s12903-026-08403-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite in people with Composite Restoration and Composites Resins, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcomes are: surface luster, marginal staining, marginal adaptation, fracture, secondary caries, and postoperative sensitivity. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07285772, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.