Caries Class INCT07575282
Clinical Evaluation of Bulk-Fill Flowable Composite Versus Submicron Hybrid Composite in Class I Carious Cavities.
A study testing Bulk-fill flowable resin-based composite. and Submicron hybrid resin- based composite. in people with Caries Class I, run by Cairo University.
Trial summary
The study aims to evaluate the clinical performance of Bulk-fill flowable resin-based composite versus submicron hybrid resin-based composite restoration in patients with posterior class I carious cavities. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Caries Class I
- What is being tested?
- Bulk-fill flowable resin-based composite. and Submicron hybrid resin- based composite.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Co-operative patients approving to participate in the trial
- Simple class I carious lesion scored based on the International Caries Detection and Assessment System (ICDAS) is code 2 or 3
- Vital upper or lower molar
- Presence of favorable occlusion.
- Presence of opposing teeth.
- Proper teeth aligment.
Who cannot join
- Patients with poor oral hygiene
- Bruxism or occlusion abnormalities.
- Allergic reaction to the materials used.
- Disabilities
- Pregnancy
- Heavy smoking
Show all 15Show fewer
- Xerostomia
- Lack of Compliance
- TMJ disorders
- Unwillingness or inability to attend follow-ups.
- Deep caries close to pulp.
- Teeth with signs/symptoms of irreversible pulpitis or necrosis.
- Endodontically treated teeth.
- Extensive occlusal destruction
- Periodontal affection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of Bulk-Fill Flowable Resin-Based Composite Versus Submicron Hybrid Resin-Based Composite in Class I Carious Cavities Over 18-Month: Randomized Controlled Trial.
The study aims to evaluate the clinical performance of Bulk-fill flowable resin-based composite versus submicron hybrid resin-based composite restoration in patients with posterior class I carious cavities.
Read the detailed description
Resin-based composites are now the preferred material for posterior tooth restoration Silva et al.,2023. To combat the polymerization shrinkage of resin-based composites, an incremental method for placing composite resin was created. Nevertheless, this method takes a lot of time and could cause air to become trapped between successive composite resin layers. Some structural and chemical modifications to the composite resin composition have been suggested in an attempt to lessen the undesirable consequences of the composites, such as the tension produced on the tooth or restoration interface Arbildo-Vega et al.,2020.
Newer resin formulations that combine small particles (0.1 μm-1.0 μm) and submicron particles (0.04 μm) with larger filler loading percentages are referred to as submicron hybrid composites. They exhibit enhanced polishability and gloss retention, as well as greater mechanical and physical properties Vishwanath et al.,2021.
Bulk-fill resin-based composites (BF-RBCs) were introduced to the dental market in the past decade to address challenges related to the incremental placement of conventional resin-based composites in posterior teeth. Originally, the term "bulk-fill" referred to resin composites that could be used in increments of 4-5mm, making them suitable for both full-body and base bulk-fill techniques. Current commercial bulk-fill resin-based composites (BF-RBCs) can be categorized based on their viscosity into flowable (low viscosity) and sculptable (high viscosity) types. In the past, flowable bulk-fill RBCs were known to have lower mechanical properties compared to high-viscosity RBCs. However, the addition of nanofillers in the latest generation of flowable BF-RBCs has improved their mechanical properties while preserving their low viscosity Gatica et al.,2023.
For the majority of commercially available flowable BF-RBCs, the manufacturer advises applying a top layer of conventional resin composite over the restoration. This makes it possible to partially offset its decreased flexural strength and prevent the restoration from wearing out too quickly Gatica et al.,2023. However according to the manufacturer's instructions for (Brilliant Bulk-Fill Flow, Coltene/Whaledent) it can be used for fillings in the posterior region even without an additional covering layer. It is composed of pre-polymerized fillers that include dental glass with nanosilica particles and silanized fillers to enhance bonding strength within the resin matrix, along with larger dental glass fillers to minimize polymerization shrinkage.
This project will be designed to test the null hypothesis that bulk-fill flowable resin-based composite will have the same clinical performance as the submicron hybrid resin-based composite in restoring class I carious cavities according to the Modified United State Public Health Service (USPHS) criteria.
- Conditions
- Caries Class I
- Being tested
- Bulk-fill flowable resin-based composite., Submicron hybrid resin- based composite.
- Keywords
- bulk fill flowable composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulk-fill flowable resin-based composite.Other
patients with simple class I cavities to be restored with Bulk-fill flowable resin-based composite.
Submicron hybrid resin- based composite.Other
Patients with simple class I cavities to be restored with Submicron hybrid resin- based composite.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | patients with simple class I cavities to be restored with Submicron hybrid resin- based composite. Receives: Other: Submicron hybrid resin- based composite. |
| Intervention group | Experimental | patients with simple class I cavities to be restored with Bulk-fill flowable resin-based composite. Receives: Other: Bulk-fill flowable resin-based composite. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of the restoration by Modified US Public Health Service Criteria (USPHS).(Mechanical performance) (Anatomic contour).
The scoring will be: Alpha (means ideal), Bravo (means acceptable), Charlie (means unacceptable) and Delta (means severe failure).
Measured: 18 months (baseline,6,12,18 months)
Secondary outcomes (1)
Clinical performance of the restoration by Modified US Public Health Service Criteria (USPHS). (Esthetic and sensitivity).
The scoring will be: Alpha (means ideal), Bravo (means acceptable), Charlie (means unacceptable) and Delta (means severe failure).
Measured: 18 months (baseline,6,12,18 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study startAug 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Caries Class IStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Mohamed Elsayed Ahmed, Cairo University
- Investigators
- Rania Sayed Mosallam, professor, Study director, Prof. Dr. Rania Sayed Mosallam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575282
- Sponsor's protocol ID
- BFFCs in Class I cavities
- Status last verified
- May 2026
- First submitted
- 2 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arbildo-Vega HI, Lapinska B, Panda S, Lamas-Lara C, Khan AS, Lukomska-Szymanska M. Clinical Effectiveness of Bulk-Fill and Conventional Resin Composite Restorations: Systematic Review and Meta-Analysis. Polymers (Basel). 2020 Aug 10;12(8):1786. doi: 10.3390/polym12081786.
PubMed 32785019Atreja A, Bellam N, Levy SR. Strategies to enhance patient adherence: making it simple. MedGenMed. 2005 Mar 16;7(1):4.
PubMed 16369309Vishwanath, V., Rao, M.H. and Prasad, B.K., 2021. Clinical performance of a direct submicron hybrid and indirect zirconium reinforced composite restorations: A 2-year assessment. SRM Journal of Research in Dental Sciences, 12(2), pp.79 85.
Tyas MJ. Clinical evaluation of glass-ionomer cement restorations. J Appl Oral Sci. 2006;14 Suppl:10-3. doi: 10.1590/s1678-77572006000700003.
PubMed 19089080Silva G, Marto CM, Amaro I, Coelho A, Sousa J, Ferreira MM, Francisco I, Vale F, Oliveiros B, Carrilho E, Paula AB. Bulk-Fill Resins versus Conventional Resins: An Umbrella Review. Polymers (Basel). 2023 Jun 8;15(12):2613. doi: 10.3390/polym15122613.
PubMed 37376259Parra Gatica E, Duran Ojeda G, Wendler M. Contemporary flowable bulk-fill resin-based composites: a systematic review. Biomater Investig Dent. 2023 Feb 22;10(1):8-19. doi: 10.1080/26415275.2023.2175685. eCollection 2023.
PubMed 37138762Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Investig. 2007 Mar;11(1):5-33. doi: 10.1007/s00784-006-0095-7. Epub 2007 Jan 30.
PubMed 17262225Canali GD, Ignacio SA, Rached RN, Souza EM. One-year clinical evaluation of bulk-fill flowable vs. regular nanofilled composite in non-carious cervical lesions. Clin Oral Investig. 2019 Feb;23(2):889-897. doi: 10.1007/s00784-018-2509-8. Epub 2018 Jun 12.
PubMed 29948275Bayne SC, Schmalz G. Reprinting the classic article on USPHS evaluation methods for measuring the clinical research performance of restorative materials. Clin Oral Investig. 2005 Dec;9(4):209-14. doi: 10.1007/s00784-005-0017-0. No abstract available.
PubMed 16421996
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Bulk-Fill Flowable Resin-Based Composite Versus Submicron Hybrid Resin-Based Composite in Class I Carious Cavities Over 18-Month: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07575282
- Acronym / sponsor ID
- BFFCs in Class I cavities
- Conditions
- Caries Class I
- Keywords
- bulk fill flowable composite
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 8 May 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 study aims to evaluate the clinical performance of Bulk-fill flowable resin-based composite versus submicron hybrid resin-based composite restoration in patients with posterior class I carious cavities.
Detailed description
Resin-based composites are now the preferred material for posterior tooth restoration Silva et al.,2023. To combat the polymerization shrinkage of resin-based composites, an incremental method for placing composite resin was created. Nevertheless, this method takes a lot of time and could cause air to become trapped between successive composite resin layers. Some structural and chemical modifications to the composite resin composition have been suggested in an attempt to lessen the undesirable consequences of the composites, such as the tension produced on the tooth or restoration interface Arbildo-Vega et al.,2020.
Newer resin formulations that combine small particles (0.1 μm-1.0 μm) and submicron particles (0.04 μm) with larger filler loading percentages are referred to as submicron hybrid composites. They exhibit enhanced polishability and gloss retention, as well as greater mechanical and physical properties Vishwanath et al.,2021.
Bulk-fill resin-based composites (BF-RBCs) were introduced to the dental market in the past decade to address challenges related to the incremental placement of conventional resin-based composites in posterior teeth. Originally, the term "bulk-fill" referred to resin composites that could be used in increments of 4-5mm, making them suitable for both full-body and base bulk-fill techniques. Current commercial bulk-fill resin-based composites (BF-RBCs) can be categorized based on their viscosity into flowable (low viscosity) and sculptable (high viscosity) types. In the past, flowable bulk-fill RBCs were known to have lower mechanical properties compared to high-viscosity RBCs. However, the addition of nanofillers in the latest generation of flowable BF-RBCs has improved their mechanical properties while preserving their low viscosity Gatica et al.,2023.
For the majority of commercially available flowable BF-RBCs, the manufacturer advises applying a top layer of conventional resin composite over the restoration. This makes it possible to partially offset its decreased flexural strength and prevent the restoration from wearing out too quickly Gatica et al.,2023. However according to the manufacturer's instructions for (Brilliant Bulk-Fill Flow, Coltene/Whaledent) it can be used for fillings in the posterior region even without an additional covering layer. It is composed of pre-polymerized fillers that include dental glass with nanosilica particles and silanized fillers to enhance bonding strength within the resin matrix, along with larger dental glass fillers to minimize polymerization shrinkage.
This project will be designed to test the null hypothesis that bulk-fill flowable resin-based composite will have the same clinical performance as the submicron hybrid resin-based composite in restoring class I carious cavities according to the Modified United State Public Health Service (USPHS) criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Submicron hybrid resin- based composite.patients with simple class I cavities to be restored with Submicron hybrid resin- based composite. |
| Intervention group | Experimental | Other: Bulk-fill flowable resin-based composite.patients with simple class I cavities to be restored with Bulk-fill flowable resin-based composite. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Co-operative patients approving to participate in the trial
- Simple class I carious lesion scored based on the International Caries Detection and Assessment System (ICDAS) is code 2 or 3
- Vital upper or lower molar
- Presence of favorable occlusion.
- Presence of opposing teeth.
Key exclusion criteria (15 listed)
- Patients with poor oral hygiene
- Bruxism or occlusion abnormalities.
- Allergic reaction to the materials used.
- Disabilities
- Pregnancy
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 |
|---|---|---|
| Bulk-fill flowable resin-based composite.patients with simple class I cavities to be restored with Bulk-fill flowable resin-based composite. | Other | Intervention group |
| Submicron hybrid resin- based composite.Patients with simple class I cavities to be restored with Submicron hybrid resin- based composite. | Other | control group |
Primary outcome
Clinical performance of the restoration by Modified US Public Health Service Criteria (USPHS).(Mechanical performance) (Anatomic contour).
Time frame: 18 months (baseline,6,12,18 months)
The scoring will be: Alpha (means ideal), Bravo (means acceptable), Charlie (means unacceptable) and Delta (means severe failure).
1 secondary outcome
Clinical performance of the restoration by Modified US Public Health Service Criteria (USPHS). (Esthetic and sensitivity).
Time frame: 18 months (baseline,6,12,18 month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 32785019Arbildo-Vega HI, Lapinska B, Panda S, Lamas-Lara C, Khan AS, Lukomska-Szymanska M. Clinical Effectiveness of Bulk-Fill and Conventional Resin Composite Restorations: Systematic Review and Meta-Analysis. Polymers (Basel). 2020 Aug 10;12(8):1786. doi: 10.3390/polym12081786.
- Background: PubMed 16369309Atreja A, Bellam N, Levy SR. Strategies to enhance patient adherence: making it simple. MedGenMed. 2005 Mar 16;7(1):4.
- BackgroundVishwanath, V., Rao, M.H. and Prasad, B.K., 2021. Clinical performance of a direct submicron hybrid and indirect zirconium reinforced composite restorations: A 2-year assessment. SRM Journal of Research in Dental Sciences, 12(2), pp.79 85.
- Background: PubMed 19089080Tyas MJ. Clinical evaluation of glass-ionomer cement restorations. J Appl Oral Sci. 2006;14 Suppl:10-3. doi: 10.1590/s1678-77572006000700003.
- Background: PubMed 37376259Silva G, Marto CM, Amaro I, Coelho A, Sousa J, Ferreira MM, Francisco I, Vale F, Oliveiros B, Carrilho E, Paula AB. Bulk-Fill Resins versus Conventional Resins: An Umbrella Review. Polymers (Basel). 2023 Jun 8;15(12):2613. doi: 10.3390/polym15122613.
- Background: PubMed 37138762Parra Gatica E, Duran Ojeda G, Wendler M. Contemporary flowable bulk-fill resin-based composites: a systematic review. Biomater Investig Dent. 2023 Feb 22;10(1):8-19. doi: 10.1080/26415275.2023.2175685. eCollection 2023.
- Background: PubMed 17262225Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Investig. 2007 Mar;11(1):5-33. doi: 10.1007/s00784-006-0095-7. Epub 2007 Jan 30.
- Background: PubMed 29948275Canali GD, Ignacio SA, Rached RN, Souza EM. One-year clinical evaluation of bulk-fill flowable vs. regular nanofilled composite in non-carious cervical lesions. Clin Oral Investig. 2019 Feb;23(2):889-897. doi: 10.1007/s00784-018-2509-8. Epub 2018 Jun 12.
- Background: PubMed 16421996Bayne SC, Schmalz G. Reprinting the classic article on USPHS evaluation methods for measuring the clinical research performance of restorative materials. Clin Oral Investig. 2005 Dec;9(4):209-14. doi: 10.1007/s00784-005-0017-0. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Rania Sayed Mosallam, professor study director
Prof. Dr. Rania Sayed Mosallam
Questions about this trial
What is this clinical trial studying?
A study testing Bulk-fill flowable resin-based composite. and Submicron hybrid resin- based composite. in people with Caries Class I, run by Cairo University.
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 6 inclusion and 15 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: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huda Mohamed Elsayed Ahmed (00201112099162, huda.elsayed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance of the restoration by Modified US Public Health Service Criteria (USPHS).(Mechanical performance) (Anatomic contour). (time frame: 18 months (baseline,6,12,18 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 NCT07575282, which also lists 9 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 13 May 2026.