Clinical Performance of Various Bilayer Biomimetic Resin Composite Strategies

NCT07285772 | Completed DMC

• 1 other identifier: biomimetic resin composite
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate several bilayer biomimetic composite resin techniques in class I cavities over the course of 18 months in a randomized, double-blind clinical trial.

Conditions

Composites Resins; Composite Restoration

Keywords

Clinical; Biomimetic; Composite; Class I

Outcome Measures

Primary Outcomes (1)

• The primary outcomes are: surface luster, marginal staining, marginal adaptation, fracture, secondary caries, and postoperative sensitivity.

  Clinical assessment was carried out according to the World Dental Federation (FDI) by two calibrated evaluators at baseline and at 6, 9, 12, and 18 months. All of the restorations were ranked according to how well they met the criteria: clinically excellent or very satisfactory, clinically satisfactory, clinically satisfactory, or clinically inadequate. Clinical success was defined as a score of 1, 2, or 3, and failure was indicated by scores of 4 or 5. A powerful light source was used to conduct the visual inspection of the parameters. A magnifying dental loupe was utilized for this purpose. The Friedman test was conducted to evaluate intragroup comparisons of the same restoration outcomes through different follow-up periods. The Kruskal-Wallis test was utilized to assess intergroup comparisons between different restorations during the same follow-up period.

  18 months

Study Arms (4)

EverX Posterior composite

EXPERIMENTAL

Short fiber-reinforced composite

Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite

Ribbond

EXPERIMENTAL

Long fiber-reinforced composite

Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite

Riva SDI

EXPERIMENTAL

glass ionomer restorative material

Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite

G-aenial universal Flo

EXPERIMENTAL

flowable composite

Other: short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite

Interventions

short fiber reinforced composite , long fiber reinforced composite, light cure glass, flowable composite OTHER

All patients received four various bilayer biomimetic restorations in four groups (n = 40) as follows: Group I: short fiber reinforced composite (everX Posterior); ); Group II: long fiber reinforced composite (Ribbond Inc., USA); Group III: glass ionomer restorative materials (Riva SDI); and Group IV: flowable composite (G-aenial universal).

EverX Posterior composite; G-aenial universal Flo; Ribbond; Riva SDI

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Proper oral hygiene
• Availability for follow-up periods

You may not qualify if:

• Endodontically treated or non-vital teeth
• Parafunctional habits such as tooth clenching or grinding

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Restorative Department, Faculty of Dentistry, Tanta University

Tanta, Tanta, Egypt

Location

Related Publications (4)

• Tanner J, Tolvanen M, Garoushi S, Sailynoja E. Clinical Evaluation of Fiber-Reinforced Composite Restorations in Posterior Teeth - Results of 2.5 Year Follow-up. Open Dent J. 2018 Jun 29;12:476-485. doi: 10.2174/1874210601812010476. eCollection 2018.

  PMID: 30069257 BACKGROUND

• ElAziz RH, Mohammed MM, Gomaa HA. Clinical Performance of Short-fiber-reinforced Resin Composite Restorations vs Resin Composite Onlay Restorations in Complex Cavities of Molars (Randomized Clinical Trial). J Contemp Dent Pract. 2020 Mar 1;21(3):296-303.

  PMID: 32434978 BACKGROUND

• Metwaly AA, Elzoghby AF, Abd ElAziz RH. Clinical performance of polyethylenefiber reinforced resin composite restorations in endodontically treated teeth: (a randomized controlled clinical trial). BMC Oral Health. 2024 Oct 24;24(1):1285. doi: 10.1186/s12903-024-05009-8.

  PMID: 39448991 BACKGROUND

• Mohamed MH, Abouauf EA, Mosallam RS. Clinical performance of class II MOD fiber reinforced resin composite restorations: an 18-month randomized controlled clinical trial. BMC Oral Health. 2025 Jan 30;25(1):159. doi: 10.1186/s12903-025-05521-5.

  PMID: 39881262 BACKGROUND

MeSH Terms

Interventions

flowable hybrid composite

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: Doctor

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 16, 2025
• Study Start: January 1, 2024
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)