- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07491770
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
36
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Xtra fill composite
Preheated composite resin at 54°C
|
A nanohybrid composite resin preheated prior to placement to improve flowability and adaptation in Class V restorations
|
|
Experimental: SonicFill 2
Sonic-activated composite
|
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
|
A highly filled flowable composite (G-aenial Universal Flo®) with improved mechanical properties compared to conventional flowables
|
|
Experimental: NanoPaq composite
Conventional nanohybrid composite
|
A standard nanohybrid composite (NanoPaq®) used according to manufacturer instructions without modification
|
What is the study measuring?
Primary Outcome Measures
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
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
- 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.
- 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.
- 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.
- 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.
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)
March 1, 2025
Primary Completion (Actual)
March 10, 2026
Study Completion (Actual)
March 14, 2026
Study Registration Dates
First Submitted
March 15, 2026
First Submitted That Met QC Criteria
March 19, 2026
First Posted (Actual)
March 24, 2026
Study Record Updates
Last Update Posted (Actual)
March 24, 2026
Last Update Submitted That Met QC Criteria
March 19, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID 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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