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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

Other trials in Egypt

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 groups in NCT07491770
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.

1 Mar 202514 Mar 2026

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)

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 34564200
Goda 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 38400614
Aref 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 40713556
Demirel 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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

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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Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
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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?

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.