Clinical Assessment of Viscosity-Modified Composite Resins: Preheated, Sonic Activated, and Flowable Resins in Class V Restorations

March 19, 2026 updated by: Mohammed Abd El Ghany Mohammed, Tanta University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Tanta
      • Tanta, Tanta, Egypt, 31527
        • Restorative Department, Faculty of Dentistry, Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Good general and oral health
  • Vital teeth
  • Class V cavities with depth ranging from 2 to 3 mm

Exclusion Criteria:

  • Non-vital or restored teeth
  • Para functional habits (e.g., bruxism)
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Xtra fill composite
Preheated composite resin at 54°C
Other: Preheated Nanohybrid Composite Resin (x tra fill)
A nanohybrid composite resin preheated prior to placement to improve flowability and adaptation in Class V restorations
Experimental: SonicFill 2
Sonic-activated composite
Other: 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.
Experimental: G-aenial Universal Flo
Highly filled flowable
Other: 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
Experimental: NanoPaq composite
Conventional nanohybrid composite
Other: Conventional Nanohybrid Composite Resin (NanoPaq®, Germany)
A standard nanohybrid composite (NanoPaq®) used according to manufacturer instructions without modification

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 14, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Composite Resin Restorations

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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