Dental Restoration FailureNCT05380973
Clinical Performance of Two Fiber Reinforced Resin Composites Versus Nanohybrid Resin Composite in Posterior Teeth Will be Evaluated Using Modified USPHS Criteria
A study testing Short fiber resin composite and Polyethylene ribbon fiber in people with Dental Restoration Failure, run by Cairo University at 1 site in Egypt.
Trial summary
This study is conducted to evaluate the clinical performance of two fiber-reinforced resin composite restorations compared to nanohybrid resin composite restorations in patients with posterior MOD cavities Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure
- What is being tested?
- Short fiber resin composite and Polyethylene ribbon fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2023to 10 Oct 2024
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- MOD carious lesions premolars and molars.
- Vital upper or lower teeth with no signs of irreversible pulpitis.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Who cannot join
- Deep carious defects (close to pulp, less than 1 mm distance).
- Periapical pathology or signs of pulpal pathology.
- Endodontically treated teeth.
- Tooth hypersensitivity.
- Possible prosthodontic restoration of teeth.
- Heavy occlusion and occlusal contacts or history of bruxism
- Severe periodontal affection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Two Fiber Reinforced Resin Composites Versus Nanohybrid Resin Composite in Posterior Restorations: Randomized Clinical Trial
This study is conducted to evaluate the clinical performance of two fiber-reinforced resin composite restorations compared to nanohybrid resin composite restorations in patients with posterior MOD cavities
Read the detailed description
Statement of the problem:
With limited evidence based information in literature about using fiber-reinforced composite (FRC) restorations in stress bearing posterior areas, it is beneficial to evaluate the newly introduced materials using a randomized clinical trial to test the null hypothesis that this new material "fiber reinforced resin composites" will have the same clinical performance as the nanohybrid resin composite restoration in such situation
Rationale:
Improvements concerning the esthetic and mechanical properties of dental resin composites have resulted in widespread use of these materials in both anterior and posterior teeth. However, resin composites still have a number of limitations in posterior teeth, mainly because of problems related to technique sensitivity, polymerization shrinkage and low fracture resistance, Due the failures of this kind, it is still controversial, whether restorative composites should be used in large high-stress bearing applications such as in direct posterior restorations.
Fiber-reinforcement of resin-based composite restorations has been proposed to increase resistance of materials fracturing under high stress-bearing cavities. Fiber-reinforced composite (FRC) is made of a polymer matrix, impregnated with fibers. The fibers allow the stresses to be distributed throughout the restoration. Since the role of the fibers is to improve the structura lproperties of the material by acting as crack stoppers, the FRC framework provides strength and rigidity of the composite materials.
The common types of fibers used in dentistry are glass and polyethylene fibers. Composite resin reinforced with short E-glass fiber fillers showed substantial improvements in the load bearing capacity, the flexural strength and fracture toughness of in comparison with conventional particulate filler restorative composite resin. The short fiber composite resin has also revealed control of the polymerization shrinkage stress by fiber orientation and, thus, marginal microleakage was reduced compared with conventional particulate filler restorative composite resins.
Polyethylene fibers are one of the most durable reinforcing fibers available. They are made of aligned polymer chains, having low modulus and density, and presents good impact resistance.They are white in colour and thus it is possible to use them in aesthetic dental applications, the use of polyethylene fiber ribbon in combination with bonding agent and flowable composite under composite restoration may act as a stress absorber because of its lower elastic modulus thereby increasing fracture resistance
- Conditions
- Dental Restoration Failure
- Being tested
- Short fiber resin composite, Polyethylene ribbon fiber
- Keywords
- polyethylene fiber reinforced resin composite, glass fiber reinforced resin composite, nanohybrid resin composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short fiber resin compositeOther
Also called (Ever X Posterior, GC, Japan)
resin composite reinforced with short glass fibers
Polyethylene ribbon fiberOther
Also called (Ribbond Inc., Seattle, WA, USA)
resin composite reinforced with polyethylene ribbon fiber
| Study group | Role | What they receive |
|---|---|---|
| fiber reinforced resin composite | Experimental | Short fiber resin composite (SFRC) (Ever X Posterior, GC, Japan) The material will be applied according to manufacturer instructions. A thin layer of flowable resin composite will be applied prior placing the short fiber reinforced composite, then SFRC (Ever X Posterior, GC, Tokyo, Japan) will be injected in bulk, and light cured for 20 seconds, nanohybrid resin composite will be placed to the rest of the cavity incrementally.
Polyethylene ribbon fiber (Ribbond Inc., Seattle, WA, USA) The material will be applied according to manufacturer instructions. After application of a thin layer of the flowable resin composite to the cavity, a layer of Polyethylene ribbon fiber on the unpolymerized flowable composite will be condensed with a plugger and polymerized for 20 seconds then, nanohybrid resin composite will be placed to the rest of the cavity incrementally. Receives: Other: Short fiber resin composite; Other: Polyethylene ribbon fiber |
| Nanohybrid resin composite | Active comparator | A thin layer of flowable composite will be applied then nanohybrid resin composite will be applied to the rest of the cavity using the conventional incremental technique according to manufacturer instructions. Receives: Other: Short fiber resin composite; Other: Polyethylene ribbon fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the clinical performance
Measured using modified USPHS criteria for clinical evaluation of restoration failure.
Measured: Change from the baseline at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start10 Apr 2023
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Restoration FailureStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hamdy Mohamed Kamal, Cairo University
- Investigators
- Rania Sayed Mosallam, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380973
- Sponsor's protocol ID
- Fiber reinforced composite
- Status last verified
- Nov 2024
- First submitted
- 14 May 2022
- Last updated
- 26 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39881262
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Two Fiber Reinforced Resin Composites Versus Nanohybrid Resin Composite in Posterior Restorations: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05380973
- Acronym / sponsor ID
- Fiber reinforced composite
- Conditions
- Dental Restoration Failure
- Keywords
- polyethylene fiber reinforced resin composite, glass fiber reinforced resin composite, nanohybrid resin composite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 19 May 2022 (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.
This study is conducted to evaluate the clinical performance of two fiber-reinforced resin composite restorations compared to nanohybrid resin composite restorations in patients with posterior MOD cavities
Detailed description
Statement of the problem:
With limited evidence based information in literature about using fiber-reinforced composite (FRC) restorations in stress bearing posterior areas, it is beneficial to evaluate the newly introduced materials using a randomized clinical trial to test the null hypothesis that this new material "fiber reinforced resin composites" will have the same clinical performance as the nanohybrid resin composite restoration in such situation
Rationale:
Improvements concerning the esthetic and mechanical properties of dental resin composites have resulted in widespread use of these materials in both anterior and posterior teeth. However, resin composites still have a number of limitations in posterior teeth, mainly because of problems related to technique sensitivity, polymerization shrinkage and low fracture resistance, Due the failures of this kind, it is still controversial, whether restorative composites should be used in large high-stress bearing applications such as in direct posterior restorations.
Fiber-reinforcement of resin-based composite restorations has been proposed to increase resistance of materials fracturing under high stress-bearing cavities. Fiber-reinforced composite (FRC) is made of a polymer matrix, impregnated with fibers. The fibers allow the stresses to be distributed throughout the restoration. Since the role of the fibers is to improve the structura lproperties of the material by acting as crack stoppers, the FRC framework provides strength and rigidity of the composite materials.
The common types of fibers used in dentistry are glass and polyethylene fibers. Composite resin reinforced with short E-glass fiber fillers showed substantial improvements in the load bearing capacity, the flexural strength and fracture toughness of in comparison with conventional particulate filler restorative composite resin. The short fiber composite resin has also revealed control of the polymerization shrinkage stress by fiber orientation and, thus, marginal microleakage was reduced compared with conventional particulate filler restorative composite resins.
Polyethylene fibers are one of the most durable reinforcing fibers available. They are made of aligned polymer chains, having low modulus and density, and presents good impact resistance.They are white in colour and thus it is possible to use them in aesthetic dental applications, the use of polyethylene fiber ribbon in combination with bonding agent and flowable composite under composite restoration may act as a stress absorber because of its lower elastic modulus thereby increasing fracture resistance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fiber reinforced resin composite | Experimental | Other: Short fiber resin composite, Other: Polyethylene ribbon fiberShort fiber resin composite (SFRC) (Ever X Posterior, GC, Japan) The material will be applied according to manufacturer instructions. A thin layer of flowable resin composite will be applied prior placing the short fiber reinforced composite, then SFRC (Ever X Posterior, GC, Tokyo, Japan) will be injected in bulk, and light cured for 20 seconds, nanohybrid resin composite will be placed to the rest of the cavity incrementally. Polyethylene ribbon fiber (Ribbond Inc., Seattle, WA, USA) The material will be applied according to manufacturer instructions. After application of a thin layer of the flowable resin composite to the cavity, a layer of Polyethylene ribbon fiber on the unpolymerized flowable composite will be condensed with a plugger and polymerized for 20 seconds then, nanohybrid resin composite will be placed to the rest of the cavity incrementally. |
| Nanohybrid resin composite | Active comparator | Other: Short fiber resin composite, Other: Polyethylene ribbon fiberA thin layer of flowable composite will be applied then nanohybrid resin composite will be applied to the rest of the cavity using the conventional incremental technique according to manufacturer instructions. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- MOD carious lesions premolars and molars.
- Vital upper or lower teeth with no signs of irreversible pulpitis.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Key exclusion criteria (7 listed)
- Deep carious defects (close to pulp, less than 1 mm distance).
- Periapical pathology or signs of pulpal pathology.
- Endodontically treated teeth.
- Tooth hypersensitivity.
- Possible prosthodontic restoration of teeth.
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 resin compositeAlso: (Ever X Posterior, GC, Japan)resin composite reinforced with short glass fibers | Other | Nanohybrid resin composite, fiber reinforced resin composite |
| Polyethylene ribbon fiberAlso: (Ribbond Inc., Seattle, WA, USA)resin composite reinforced with polyethylene ribbon fiber | Other | Nanohybrid resin composite, fiber reinforced resin composite |
Primary outcome
Change in the clinical performance
Time frame: Change from the baseline at 12 months.
Measured using modified USPHS criteria for clinical evaluation of restoration failure.
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 26 Nov 2024.
- Derived from this study: 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.
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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.
Rania Sayed Mosallam study director
Professor
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 resin composite and Polyethylene ribbon fiber in people with Dental Restoration Failure, run by Cairo 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 3 inclusion and 7 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 26 Nov 2024. 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?
Change in the clinical performance (time frame: Change from the baseline at 12 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 NCT05380973, which also lists 1 linked publication.
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 26 Nov 2024.