Composite ResinsNCT07496047
Clinical Evaluation of Short Fiber-Reinforced Composite Restorations With and Without Preheating Approach
A study testing Preheated everX Posterior composite and Non-preheated everX Posterior composite in people with Composite Resins and Teeth Sensitivity, run by Tanta University at 2 sites in Egypt.
Trial summary
To clinically evaluate the performance of preheated versus non-preheated short fiber-reinforced composite (SFRC) restorations in Class I posterior cavities over a 12-month period Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Composite Resins, Teeth Sensitivity, Restoration Design
- What is being tested?
- Preheated everX Posterior composite and Non-preheated everX Posterior composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2025to 20 Mar 2026
- 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of bilateral Class I carious lesions in posterior teeth requiring restorative treatment
- Teeth with vital pulps and no signs of irreversible pulpitis
- Good general health
Who cannot join
- Patients with poor oral hygiene or high caries risk
- Presence of parafunctional habits (e.g., bruxism)
- Patients with systemic diseases affecting oral health or salivary flow
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Restorative Department, Faculty of Dentistry, Tanta University
Tanta, Tanta, 31527
Restorative Department, Faculty of Dentistry, Tanta University
Tanta, Tanta
About this study
To clinically evaluate the performance of preheated versus non-preheated short fiber-reinforced composite (SFRC) restorations in Class I posterior cavities over a 12-month period
Read the detailed description
Resin-based composites are widely used for posterior restorations due to their aesthetic properties and adhesive capabilities. However, polymerization shrinkage stress and insufficient fracture resistance remain major concerns in stress-bearing areas.
Short fiber-reinforced composites (SFRCs) were developed to improve mechanical properties and crack-stopping ability. everX Posterior (GC Corporation, Tokyo, Japan) contains randomly oriented E-glass fibers within a resin matrix, enhancing fracture toughness and load-bearing capacity.
Preheating composite materials has been proposed to reduce viscosity, improve flow, enhance cavity adaptation, and potentially increase the degree of conversion. Elevated temperature reduces internal friction among monomers, thereby improving polymerization kinetics. Despite promising laboratory findings, limited clinical evidence exists regarding the impact of preheating on SFRC performance.
Therefore, this randomized clinical trial aimed to evaluate the clinical behavior of SFRC restorations placed with and without preheating in Class I cavities over 12 months
- Being tested
- Preheated everX Posterior composite, Non-preheated everX Posterior composite
- Keywords
- Short fiber-reinforced composite, preheating, Class I cavities, FDI criteria, randomized clinical trial
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preheated everX Posterior compositeOther
Application of everX Posterior composite after preheating to 54°C using a composite warmer, followed by placement, adaptation, and curing according to manufacturer guidelines.
Non-preheated everX Posterior compositeOther
Application of everX Posterior composite at room temperature, placed and cured according to manufacturer instructions.
| Study group | Role | What they receive |
|---|---|---|
| Preheated Short Fiber-Reinforced Composite (SFRC) Restorations | Experimental | Not described Receives: Other: Preheated everX Posterior composite |
| Non-Preheated Short Fiber-Reinforced Composite (SFRC) Restorations | Experimental | Not described Receives: Other: Non-preheated everX Posterior composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation
Assessment of the marginal integrity of restorations using FDI criteria, including presence of gaps, discoloration, or ditching at restoration margins.
Measured: Baseline, 6 months, 9 months, and 12 months
Secondary outcomes (3)
Restoration retention and fracture resistance
Evaluation of restoration survival, including retention and presence of fractures or chipping, according to FDI functional criteria.
Measured: Baseline, 6 months, 9 months, and 12 months
Postoperative sensitivity
Assessment of patient-reported sensitivity following restoration placement, evaluated clinically using FDI biological criteria
Measured: Baseline, 6 months, 9 months, and 12 months
Recurrence of caries
Detection of secondary caries associated with the restorations using clinical examination based on FDI criteria.
Measured: Baseline, 6 months, 9 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Mar 2025
- Primary completion17 Mar 2026
- Study completion20 Mar 2026
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 ResinsStudies 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
- 70 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
- NCT07496047
- Sponsor's protocol ID
- Preheated composite Resin
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hartanto C, Farahanny W, Dennis D. Comparative Evaluation of Short Fiber-reinforced Composite Resin Thickness on Fracture Resistance of Class II Composite Restoration: An In Vitro Study. J Contemp Dent Pract. 2020 Nov 1;21(11):1201-1204.
PubMed 33850063Alshabib A, Jurado CA, Tsujimoto A. Short fiber-reinforced resin-based composites (SFRCs); Current status and future perspectives. Dent Mater J. 2022 Oct 2;41(5):647-654. doi: 10.4012/dmj.2022-080. Epub 2022 Jul 20.
PubMed 35858793Mohamed 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 39881262Sen Yavuz B, Kaya R, Kodaman Dokumacigil N, Ozgur EG, Bekiroglu N, Kargul B. Clinical performance of short fiber reinforced composite and glass hybrid on hypomineralized molars: A 36-month randomized split-mouth study. J Dent. 2024 May;144:104919. doi: 10.1016/j.jdent.2024.104919. Epub 2024 Mar 1.
PubMed 38431187Hamdi K, Elsebaai A, Harp YS, Hamama HH. Clinical performance of short fiber-reinforced composite resin restoration in large posterior cavities: a systematic review and meta-analysis. Sci Rep. 2025 Dec 22;15(1):44334. doi: 10.1038/s41598-025-31441-z.
PubMed 41429866
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Short Fiber-Reinforced Composite Restorations With and Without Preheating Approach
- ClinicalTrials.gov ID
- NCT07496047
- Acronym / sponsor ID
- Preheated composite Resin
- Keywords
- Short fiber-reinforced composite, preheating, Class I cavities, FDI criteria, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 27 Mar 2026 (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.
To clinically evaluate the performance of preheated versus non-preheated short fiber-reinforced composite (SFRC) restorations in Class I posterior cavities over a 12-month period
Detailed description
Resin-based composites are widely used for posterior restorations due to their aesthetic properties and adhesive capabilities. However, polymerization shrinkage stress and insufficient fracture resistance remain major concerns in stress-bearing areas.
Short fiber-reinforced composites (SFRCs) were developed to improve mechanical properties and crack-stopping ability. everX Posterior (GC Corporation, Tokyo, Japan) contains randomly oriented E-glass fibers within a resin matrix, enhancing fracture toughness and load-bearing capacity.
Preheating composite materials has been proposed to reduce viscosity, improve flow, enhance cavity adaptation, and potentially increase the degree of conversion. Elevated temperature reduces internal friction among monomers, thereby improving polymerization kinetics. Despite promising laboratory findings, limited clinical evidence exists regarding the impact of preheating on SFRC performance.
Therefore, this randomized clinical trial aimed to evaluate the clinical behavior of SFRC restorations placed with and without preheating in Class I cavities over 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preheated Short Fiber-Reinforced Composite (SFRC) Restorations | Experimental | Other: Preheated everX Posterior composite |
| Non-Preheated Short Fiber-Reinforced Composite (SFRC) Restorations | Experimental | Other: Non-preheated everX Posterior composite |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of bilateral Class I carious lesions in posterior teeth requiring restorative treatment
- Teeth with vital pulps and no signs of irreversible pulpitis
- Good general health
Key exclusion criteria (3 listed)
- Patients with poor oral hygiene or high caries risk
- Presence of parafunctional habits (e.g., bruxism)
- Patients with systemic diseases affecting oral health or salivary flow
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 |
|---|---|---|
| Preheated everX Posterior compositeApplication of everX Posterior composite after preheating to 54°C using a composite warmer, followed by placement, adaptation, and curing according to manufacturer guidelines. | Other | Preheated Short Fiber-Reinforced Composite (SFRC) Restorations |
| Non-preheated everX Posterior compositeApplication of everX Posterior composite at room temperature, placed and cured according to manufacturer instructions. | Other | Non-Preheated Short Fiber-Reinforced Composite (SFRC) Restorations |
Primary outcome
Marginal adaptation
Time frame: Baseline, 6 months, 9 months, and 12 months
Assessment of the marginal integrity of restorations using FDI criteria, including presence of gaps, discoloration, or ditching at restoration margins.
3 secondary outcomes
Restoration retention and fracture resistance
Time frame: Baseline, 6 months, 9 months, and 12 months
Postoperative sensitivity
Time frame: Baseline, 6 months, 9 months, and 12 months
Recurrence of caries
Time frame: Baseline, 6 months, 9 months, and 12 months
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 27 Mar 2026.
- Results publication: PubMed 33850063Hartanto C, Farahanny W, Dennis D. Comparative Evaluation of Short Fiber-reinforced Composite Resin Thickness on Fracture Resistance of Class II Composite Restoration: An In Vitro Study. J Contemp Dent Pract. 2020 Nov 1;21(11):1201-1204.
- Results publication: PubMed 35858793Alshabib A, Jurado CA, Tsujimoto A. Short fiber-reinforced resin-based composites (SFRCs); Current status and future perspectives. Dent Mater J. 2022 Oct 2;41(5):647-654. doi: 10.4012/dmj.2022-080. Epub 2022 Jul 20.
- Results publication: 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.
- Results publication: PubMed 38431187Sen Yavuz B, Kaya R, Kodaman Dokumacigil N, Ozgur EG, Bekiroglu N, Kargul B. Clinical performance of short fiber reinforced composite and glass hybrid on hypomineralized molars: A 36-month randomized split-mouth study. J Dent. 2024 May;144:104919. doi: 10.1016/j.jdent.2024.104919. Epub 2024 Mar 1.
- Results publication: PubMed 41429866Hamdi K, Elsebaai A, Harp YS, Hamama HH. Clinical performance of short fiber-reinforced composite resin restoration in large posterior cavities: a systematic review and meta-analysis. Sci Rep. 2025 Dec 22;15(1):44334. doi: 10.1038/s41598-025-31441-z.
- Individual participant dataSharing planned: No
Related trials for Composite Resins
Not yet recruiting
Clinical and 3D Evaluation of Injectable Versus Conventional Composite in Class V Restorations
Class V Dental Restorations
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Enrolling by invitation
Clinical Evaluation of 3D-Printed Versus Direct Composite Restorations in Class II Cavities
3D-Printed, Direct Composite
Active, not recruiting
Two-year Clinical Performance of Ion-releasing and Conventional Bulk-fill Resin Composite Restorative Systems.
Class I Dental Caries
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preheated everX Posterior composite and Non-preheated everX Posterior composite in people with Composite Resins and Teeth Sensitivity, run by Tanta University at 2 sites 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 3 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Marginal adaptation (time frame: Baseline, 6 months, 9 months, and 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 NCT07496047, 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 27 Mar 2026.