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

NCT07491770 | Completed DMC

• 1 other identifier: Composite Resin Restorations
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Composite Restoration; Class V Restorations

Keywords

clinical; preheated; Highly filled flowable; Sonicfill; Composite Resins

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Study Arms (4)

Xtra fill composite

EXPERIMENTAL

Preheated composite resin at 54°C

Other: Preheated Nanohybrid Composite Resin (x tra fill)

SonicFill 2

EXPERIMENTAL

Sonic-activated composite

Other: Sonic-Activated Nanohybrid Composite Resin (SonicFill 2®, Kerr, USA)

G-aenial Universal Flo

EXPERIMENTAL

Highly filled flowable

Other: Highly Filled Flowable Composite Resin (G-aenial Universal Flo®, GC Corporation, Japan)

NanoPaq composite

EXPERIMENTAL

Conventional nanohybrid composite

Other: Conventional Nanohybrid Composite Resin (NanoPaq®, Germany)

Interventions

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

Xtra fill composite

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.

SonicFill 2

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

G-aenial Universal Flo

Conventional Nanohybrid Composite Resin (NanoPaq®, Germany) OTHER

A standard nanohybrid composite (NanoPaq®) used according to manufacturer instructions without modification

NanoPaq composite

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Restorative Department, Faculty of Dentistry, Tanta University

Tanta, Tanta, 31527, Egypt

Location

Related Publications (4)

• 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.

  PMID: 34564200 RESULT

• 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.

  PMID: 38400614 RESULT

• 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.

  PMID: 40713556 RESULT

• 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.

  PMID: 34242394 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 24, 2026
• Study Start: March 1, 2025
• Primary Completion: March 10, 2026
• Study Completion: March 14, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)