Composite RestorationNCT07491770
Clinical Assessment of Viscosity-Modified Composite Resins: Preheated, Sonic Activated, and Flowable Resins in Class V Restorations
A study testing Preheated Nanohybrid Composite Resin (x tra fill), Sonic-Activated Nanohybrid Composite Resin (SonicFill 2®, Kerr, USA) and Highly Filled Flowable Composite Resin (G-aenial Universal Flo®, GC Corporation, Japan) in people with Composite Restoration and Class V Restorations, run by Tanta University at 1 site in Egypt.
Trial summary
The purpose of the 12-month clinical study was to evaluate and compare preheated, sonic-activated, and flowable composite resins used in Class V restorations. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Composite Restoration, Class V Restorations
- What is being tested?
- Preheated Nanohybrid Composite Resin (x tra fill), Sonic-Activated Nanohybrid Composite Resin (SonicFill 2®, Kerr, USA) and Highly Filled Flowable Composite Resin (G-aenial Universal Flo®, GC Corporation, Japan)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 14 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
- Good general and oral health
- Vital teeth
- Class V cavities with depth ranging from 2 to 3 mm
Who cannot join
- Non-vital or restored teeth
- Para functional habits (e.g., bruxism)
- pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Restorative Department, Faculty of Dentistry, Tanta University
Tanta, Tanta, 31527
About this study
The purpose of the 12-month clinical study was to evaluate and compare preheated, sonic-activated, and flowable composite resins used in Class V restorations.
Read the detailed description
Because of their superior aesthetics, minimal preparation needs, and capacity to adhere to tooth structure, resin composite materials are now frequently utilized in restorative dentistry. Materials with superior mechanical qualities, better handling qualities, and improved clinical performance have been developed as a result of ongoing advancements in composite technology. Viscosity-modulated composite resins have drawn a lot of interest among these developments because they seek to maximize cavity wall adaptability while preserving adequate strength and wear resistance. To enhance the therapeutic performance of composite resins, various methods have been developed to alter their viscosity. One method for improving flow and adaptability to cavity walls prior to polymerization is preheating composite resins, which momentarily lowers viscosity. Sonic-activated composite methods reduce viscosity during installation by using sonic energy, which makes cavity adaption and handling easier. Moreover, highly filled flowable composite resins have been created to increase their mechanical strength in comparison to traditional flowable composites by combining the better flow properties of flowable materials with increased filler content. Thus, the goal of this study was to assess the clinical performance of flowable composite resins that are warmed, sonic-activated, and highly filled when employed in Class V cavities.
- Conditions
- Composite Restoration, Class V Restorations
- Being tested
- Preheated Nanohybrid Composite Resin (x tra fill), Sonic-Activated Nanohybrid Composite Resin (SonicFill 2®, Kerr, USA), Highly Filled Flowable Composite Resin (G-aenial Universal Flo®, GC Corporation, Japan), Conventional Nanohybrid Composite Resin (NanoPaq®, Germany)
- Keywords
- clinical, preheated, Highly filled flowable, Sonicfill, Composite Resins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preheated Nanohybrid Composite Resin (x tra fill)Other
A nanohybrid composite resin preheated prior to placement to improve flowability and adaptation in Class V restorations
Sonic-Activated Nanohybrid Composite Resin (SonicFill 2®, Kerr, USA)Other
A sonic-activated bulk-fill nanohybrid composite (SonicFill 2®) that reduces viscosity during placement using sonic energy.
Highly Filled Flowable Composite Resin (G-aenial Universal Flo®, GC Corporation, Japan)Other
A highly filled flowable composite (G-aenial Universal Flo®) with improved mechanical properties compared to conventional flowables
Conventional Nanohybrid Composite Resin (NanoPaq®, Germany)Other
A standard nanohybrid composite (NanoPaq®) used according to manufacturer instructions without modification
| Study group | Role | What they receive |
|---|---|---|
| Xtra fill composite | Experimental | Preheated composite resin at 54°C Receives: Other: Preheated Nanohybrid Composite Resin (x tra fill) |
| SonicFill 2 | Experimental | Sonic-activated composite Receives: Other: Sonic-Activated Nanohybrid Composite Resin (SonicFill 2®, Kerr, USA) |
| G-aenial Universal Flo | Experimental | Highly filled flowable Receives: Other: Highly Filled Flowable Composite Resin (G-aenial Universal Flo®, GC Corporation, Japan) |
| NanoPaq composite | Experimental | Conventional nanohybrid composite Receives: Other: Conventional Nanohybrid Composite Resin (NanoPaq®, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was marginal adaptation
Clinical assessment of marginal adaptation was carried out in accordance with the World Dental Federation (FDI) criteria by two calibrated examiners at baseline and after 6, 9, and 12 months. The restorations were graded based on their compliance with the evaluation criteria as follows: score 1 (clinically excellent), score 2 (clinically satisfactory), score 3 (clinically acceptable), and scores 4 and 5 (clinically unsatisfactory). Clinical success was considered when restorations received scores of 1, 2, or 3, whereas scores of 4 or 5 were regarded as failures. Visual examination of the evaluated parameters was performed using a high-intensity light source, and a magnifying dental loupe was used to enhance observation. Intragroup comparisons of restoration outcomes across different follow-up intervals were analyzed using the Friedman test. Intergroup comparisons among the different restorative materials within the same follow-up period were performed using the Kruskal-Wallis test. T
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Mar 2025
- Primary completion10 Mar 2026
- Study completion14 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 36 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
- NCT07491770
- Sponsor's protocol ID
- Composite Resin Restorations
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Badr C, Spagnuolo G, Amenta F, Khairallah C, Mahdi SS, Daher E, Battineni G, Baba NZ, Zogheib T, Qasim SSB, Daher T, Chintalapudi N, Zogheib CM. A Two-Year Comparative Evaluation of Clinical Performance of a Nanohybrid Composite Resin to a Flowable Composite Resin. J Funct Biomater. 2021 Sep 9;12(3):51. doi: 10.3390/jfb12030051.
PubMed 34564200Goda B, Hamdi K, Eltoukhy RI, Ali AI, Mahmoud SH. Clinical performance of different bulk-fill composite resin systems in class II cavities: A 2-year randomized clinical trial. J Esthet Restor Dent. 2024 Aug;36(8):1122-1137. doi: 10.1111/jerd.13212. Epub 2024 Feb 23.
PubMed 38400614Aref A, Abd-Elhakim S, Riad M. 24-month randomized controlled clinical trial assessment of surface texture, color stability, and marginal discoloration of sonic activated bulk-fill resin composite according to USPHS and FDI criteria. BMC Oral Health. 2025 Jul 26;25(1):1261. doi: 10.1186/s12903-025-06611-0.
PubMed 40713556Demirel G, Orhan AI, Irmak O, Aydin F, Buyuksungur A, Bilecenoglu B, Orhan K. Effects of Preheating and Sonic Delivery Techniques on the Internal Adaptation of Bulk-fill Resin Composites. Oper Dent. 2021 Mar 1;46(2):226-233. doi: 10.2341/19-241-L.
PubMed 34242394
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Viscosity-Modified Composite Resins: Preheated, Sonic Activated, and Flowable Resins in Class V Restorations
- ClinicalTrials.gov ID
- NCT07491770
- Acronym / sponsor ID
- Composite Resin Restorations
- Conditions
- Composite Restoration, Class V Restorations
- Keywords
- clinical, preheated, Highly filled flowable, Sonicfill, Composite Resins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 14 Mar 2026 (actual)
- First posted
- 24 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.
The purpose of the 12-month clinical study was to evaluate and compare preheated, sonic-activated, and flowable composite resins used in Class V restorations.
Detailed description
Because of their superior aesthetics, minimal preparation needs, and capacity to adhere to tooth structure, resin composite materials are now frequently utilized in restorative dentistry. Materials with superior mechanical qualities, better handling qualities, and improved clinical performance have been developed as a result of ongoing advancements in composite technology. Viscosity-modulated composite resins have drawn a lot of interest among these developments because they seek to maximize cavity wall adaptability while preserving adequate strength and wear resistance. To enhance the therapeutic performance of composite resins, various methods have been developed to alter their viscosity. One method for improving flow and adaptability to cavity walls prior to polymerization is preheating composite resins, which momentarily lowers viscosity. Sonic-activated composite methods reduce viscosity during installation by using sonic energy, which makes cavity adaption and handling easier. Moreover, highly filled flowable composite resins have been created to increase their mechanical strength in comparison to traditional flowable composites by combining the better flow properties of flowable materials with increased filler content. Thus, the goal of this study was to assess the clinical performance of flowable composite resins that are warmed, sonic-activated, and highly filled when employed in Class V cavities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Xtra fill composite | Experimental | Other: Preheated Nanohybrid Composite Resin (x tra fill)Preheated composite resin at 54°C |
| SonicFill 2 | Experimental | Other: Sonic-Activated Nanohybrid Composite Resin (SonicFill 2®, Kerr, USA)Sonic-activated composite |
| G-aenial Universal Flo | Experimental | Other: Highly Filled Flowable Composite Resin (G-aenial Universal Flo®, GC Corporation, Japan)Highly filled flowable |
| NanoPaq composite | Experimental | Other: Conventional Nanohybrid Composite Resin (NanoPaq®, Germany)Conventional nanohybrid composite |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good general and oral health
- Vital teeth
- Class V cavities with depth ranging from 2 to 3 mm
Key exclusion criteria (3 listed)
- Non-vital or restored teeth
- Para functional habits (e.g., bruxism)
- 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 |
|---|---|---|
| Preheated Nanohybrid Composite Resin (x tra fill)A nanohybrid composite resin preheated prior to placement to improve flowability and adaptation in Class V restorations | Other | Xtra fill composite |
| Sonic-Activated Nanohybrid Composite Resin (SonicFill 2®, Kerr, USA)A sonic-activated bulk-fill nanohybrid composite (SonicFill 2®) that reduces viscosity during placement using sonic energy. | Other | SonicFill 2 |
| Highly Filled Flowable Composite Resin (G-aenial Universal Flo®, GC Corporation, Japan)A highly filled flowable composite (G-aenial Universal Flo®) with improved mechanical properties compared to conventional flowables | Other | G-aenial Universal Flo |
| Conventional Nanohybrid Composite Resin (NanoPaq®, Germany)A standard nanohybrid composite (NanoPaq®) used according to manufacturer instructions without modification | Other | NanoPaq composite |
Primary outcome
The primary outcome was marginal adaptation
Time frame: 12 months
Clinical assessment of marginal adaptation was carried out in accordance with the World Dental Federation (FDI) criteria by two calibrated examiners at baseline and after 6, 9, and 12 months. The restorations were graded based on their compliance with the evaluation criteria as follows: score 1 (clinically excellent), score 2 (clinically satisfactory), score 3 (clinically acceptable), and scores 4 and 5 (clinically unsatisfactory). Clinical success was considered when restorations received scores of 1, 2, or 3, whereas scores of 4 or 5 were regarded as failures. Visual examination of the evaluated parameters was performed using a high-intensity light source, and a magnifying dental loupe was used to enhance observation. Intragroup comparisons of restoration outcomes across different follow-up intervals were analyzed using the Friedman test. Intergroup comparisons among the different restorative materials within the same follow-up period were performed using the Kruskal-Wallis test. T
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 24 Mar 2026.
- Results publication: PubMed 34564200Badr C, Spagnuolo G, Amenta F, Khairallah C, Mahdi SS, Daher E, Battineni G, Baba NZ, Zogheib T, Qasim SSB, Daher T, Chintalapudi N, Zogheib CM. A Two-Year Comparative Evaluation of Clinical Performance of a Nanohybrid Composite Resin to a Flowable Composite Resin. J Funct Biomater. 2021 Sep 9;12(3):51. doi: 10.3390/jfb12030051.
- Results publication: PubMed 38400614Goda B, Hamdi K, Eltoukhy RI, Ali AI, Mahmoud SH. Clinical performance of different bulk-fill composite resin systems in class II cavities: A 2-year randomized clinical trial. J Esthet Restor Dent. 2024 Aug;36(8):1122-1137. doi: 10.1111/jerd.13212. Epub 2024 Feb 23.
- Results publication: PubMed 40713556Aref A, Abd-Elhakim S, Riad M. 24-month randomized controlled clinical trial assessment of surface texture, color stability, and marginal discoloration of sonic activated bulk-fill resin composite according to USPHS and FDI criteria. BMC Oral Health. 2025 Jul 26;25(1):1261. doi: 10.1186/s12903-025-06611-0.
- Results publication: PubMed 34242394Demirel G, Orhan AI, Irmak O, Aydin F, Buyuksungur A, Bilecenoglu B, Orhan K. Effects of Preheating and Sonic Delivery Techniques on the Internal Adaptation of Bulk-fill Resin Composites. Oper Dent. 2021 Mar 1;46(2):226-233. doi: 10.2341/19-241-L.
- 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 Preheated Nanohybrid Composite Resin (x tra fill), Sonic-Activated Nanohybrid Composite Resin (SonicFill 2®, Kerr, USA) and Highly Filled Flowable Composite Resin (G-aenial Universal Flo®, GC Corporation, Japan) in people with Composite Restoration and Class V Restorations, 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 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 24 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 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 outcome was marginal adaptation (time frame: 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 NCT07491770, which also lists 4 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 24 Mar 2026.