Caries; DentinNCT07320885
Clinical Performance of Fiber-Reinforced Dentin Replacement Materials
A study testing Ever x flow, SDR and Tetric N-Flow Bulk fill in people with Caries; Dentin and Caries Class II, run by Mansoura University at 1 site in Egypt.
Trial summary
the current study was conducted to evaluate and compare the flowable short fiber-reinforced (SFRC) and flowable bulk-fill resin composites (BFCs) regarding their 4-year clinical performance as dentin replacement materials in class II cavities. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Caries; Dentin, Caries Class II
- What is being tested?
- Ever x flow, SDR and Tetric N-Flow Bulk fill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 15 Aug 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- having good oral hygiene.
- having at least 3 posterior teeth with moderate to large primary proximal carious lesions (score 4 or 5 ICDAS).
- ranging in age from 20 to 40 years.
- with normal occlusion.
- accepting to participate in the study by signing an Arabic-written consent according to the regulations of the Mansoura University Ethical Committee.
Who cannot join
- bad oral hygiene.
- severe chronic periodontitis.
- having installed orthodontic appliances.
- abnormal occlusion.
- parafunctional habits or allergic reaction to any of the materials used in the study.
- teeth with irreversible pulpitis or non-vital teeth.
- fractured or cracked teeth. previously restored teeth.
- teeth with deep sub-gingival cavity margins.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fiber-Reinforced Versus Bulk-Fill Flowable Resin Composite Dentin Replacement Materials: 4-Year Clinical Performance in Class II Cavities
the current study was conducted to evaluate and compare the flowable short fiber-reinforced (SFRC) and flowable bulk-fill resin composites (BFCs) regarding their 4-year clinical performance as dentin replacement materials in class II cavities.
Read the detailed description
the current study was conducted to evaluate and compare the flowable short fiber-reinforced (SFRC) and flowable bulk-fill resin composites (BFCs) regarding their 4-year clinical performance as dentin replacement materials in class II cavities. Forty patients were enrolled in the study. Each patient received three class II cavities; one of them was restored with flowable SFRC for dentin replacement, while in the other two cavities, dentin was replaced with two different flowable BFCs. The three dentin replacements were veneered with one particulate filler resin composite (PFC) (Essentia, GC). World Dental Federation (FDI) criteria were used for clinical assessment of the restorations at 1-week (baseline), 6, 12, 18-months, 2, 3, and 4-year intervals.
- Conditions
- Caries; Dentin, Caries Class II
- Being tested
- Ever x flow, SDR, Tetric N-Flow Bulk fill
- Keywords
- Fiber-reinforced resin composite, Flowable bulk-fill resin composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ever x flowOther
Also called flowable FRC
Ever x flow was used as dentin replacement material
SDROther
SDR was used as dentin replacement material in class II cavities
Tetric N-Flow Bulk fillOther
Tetric N-Flow Bulk fill was used as dentin replacement material in class II cavities
| Study group | Role | What they receive |
|---|---|---|
| Ever x flow short-fiber reinforced composite | Experimental | Ever x flow was used as dentin replacement material in class II cavities Receives: Other: Ever x flow |
| SDR flowable bulk-fill resin composite | Experimental | SDR was used as dentin replacement material Receives: Other: SDR |
| Tetric N-Flow Bulk fill resin composite | Experimental | Tetric N-Flow Bulk fill was used as dentin replacement material Receives: Other: Tetric N-Flow Bulk fill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture of restorative material and restoration retention
Clinical evaluation was performed one week after finishing and polishing (baseline), after 6 months, 1, 2, 3, 4 years using the World Dental Federation (FDI) criteria
Measured: four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Jul 2020
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries; DentinStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youness Saleh, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320885
- Sponsor's protocol ID
- A11120520
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no specific reason
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fiber-Reinforced Versus Bulk-Fill Flowable Resin Composite Dentin Replacement Materials: 4-Year Clinical Performance in Class II Cavities
- ClinicalTrials.gov ID
- NCT07320885
- Acronym / sponsor ID
- A11120520
- Conditions
- Caries; Dentin, Caries Class II
- Keywords
- Fiber-reinforced resin composite, Flowable bulk-fill resin composite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 6 Jan 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.
the current study was conducted to evaluate and compare the flowable short fiber-reinforced (SFRC) and flowable bulk-fill resin composites (BFCs) regarding their 4-year clinical performance as dentin replacement materials in class II cavities.
Detailed description
the current study was conducted to evaluate and compare the flowable short fiber-reinforced (SFRC) and flowable bulk-fill resin composites (BFCs) regarding their 4-year clinical performance as dentin replacement materials in class II cavities. Forty patients were enrolled in the study. Each patient received three class II cavities; one of them was restored with flowable SFRC for dentin replacement, while in the other two cavities, dentin was replaced with two different flowable BFCs. The three dentin replacements were veneered with one particulate filler resin composite (PFC) (Essentia, GC). World Dental Federation (FDI) criteria were used for clinical assessment of the restorations at 1-week (baseline), 6, 12, 18-months, 2, 3, and 4-year intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ever x flow short-fiber reinforced composite | Experimental | Other: Ever x flowEver x flow was used as dentin replacement material in class II cavities |
| SDR flowable bulk-fill resin composite | Experimental | Other: SDRSDR was used as dentin replacement material |
| Tetric N-Flow Bulk fill resin composite | Experimental | Other: Tetric N-Flow Bulk fillTetric N-Flow Bulk fill was used as dentin replacement material |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- having good oral hygiene.
- having at least 3 posterior teeth with moderate to large primary proximal carious lesions (score 4 or 5 ICDAS).
- ranging in age from 20 to 40 years.
- with normal occlusion.
- accepting to participate in the study by signing an Arabic-written consent according to the regulations of the Mansoura University Ethical Committee.
Key exclusion criteria (8 listed)
- bad oral hygiene.
- severe chronic periodontitis.
- having installed orthodontic appliances.
- abnormal occlusion.
- parafunctional habits or allergic reaction to any of the materials used in the study.
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 |
|---|---|---|
| Ever x flowAlso: flowable FRCEver x flow was used as dentin replacement material | Other | Ever x flow short-fiber reinforced composite |
| SDRSDR was used as dentin replacement material in class II cavities | Other | SDR flowable bulk-fill resin composite |
| Tetric N-Flow Bulk fillTetric N-Flow Bulk fill was used as dentin replacement material in class II cavities | Other | Tetric N-Flow Bulk fill resin composite |
Primary outcome
Fracture of restorative material and restoration retention
Time frame: four years
Clinical evaluation was performed one week after finishing and polishing (baseline), after 6 months, 1, 2, 3, 4 years using the World Dental Federation (FDI) criteria
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 6 Jan 2026.
- Individual participant dataSharing planned: No. no specific reason
Related trials for Caries; Dentin
Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Active, not recruiting
Two-year Clinical Performance of Ion-releasing and Conventional Bulk-fill Resin Composite Restorative Systems.
Class I Dental Caries
Not yet recruitingPhase 3
Effectiveness of Single and Dual Silver Fluoride Application
Dentine Caries
Active, not recruiting
Outcome of Selective Caries Removal Performed by Undergraduate Students
Deep Caries Lesion of Pemanent Teeth
Enrolling by invitation
Clinical Evaluation of Dentin Replacement Materials in Posterior Composite Restorations
Dental Caries, Composite Resins
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 Ever x flow, SDR and Tetric N-Flow Bulk fill in people with Caries; Dentin and Caries Class II, run by Mansoura 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 5 inclusion and 8 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 6 Jan 2026. 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?
Fracture of restorative material and restoration retention (time frame: four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.