Clinical Evaluation of Short Fiber-Reinforced Composite Restorations With and Without Preheating Approach

March 22, 2026 updated by: Mohammed Abd El Ghany Mohammed, Tanta University
To clinically evaluate the performance of preheated versus non-preheated short fiber-reinforced composite (SFRC) restorations in Class I posterior cavities over a 12-month period

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Resin-based composites are widely used for posterior restorations due to their aesthetic properties and adhesive capabilities. However, polymerization shrinkage stress and insufficient fracture resistance remain major concerns in stress-bearing areas.

Short fiber-reinforced composites (SFRCs) were developed to improve mechanical properties and crack-stopping ability. everX Posterior (GC Corporation, Tokyo, Japan) contains randomly oriented E-glass fibers within a resin matrix, enhancing fracture toughness and load-bearing capacity.

Preheating composite materials has been proposed to reduce viscosity, improve flow, enhance cavity adaptation, and potentially increase the degree of conversion. Elevated temperature reduces internal friction among monomers, thereby improving polymerization kinetics. Despite promising laboratory findings, limited clinical evidence exists regarding the impact of preheating on SFRC performance.

Therefore, this randomized clinical trial aimed to evaluate the clinical behavior of SFRC restorations placed with and without preheating in Class I cavities over 12 months

Study Type

Interventional

Enrollment (Actual)

70

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

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

  • Presence of bilateral Class I carious lesions in posterior teeth requiring restorative treatment
  • Teeth with vital pulps and no signs of irreversible pulpitis
  • Good general health

Exclusion Criteria:

  • Patients with poor oral hygiene or high caries risk
  • Presence of parafunctional habits (e.g., bruxism)
  • Patients with systemic diseases affecting oral health or salivary flow

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: Preheated Short Fiber-Reinforced Composite (SFRC) Restorations
Other: Preheated everX Posterior composite
Application of everX Posterior composite after preheating to 54°C using a composite warmer, followed by placement, adaptation, and curing according to manufacturer guidelines.
Experimental: Non-Preheated Short Fiber-Reinforced Composite (SFRC) Restorations
Other: Non-preheated everX Posterior composite
Application of everX Posterior composite at room temperature, placed and cured according to manufacturer instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal adaptation
Time Frame: Baseline, 6 months, 9 months, and 12 months
Assessment of the marginal integrity of restorations using FDI criteria, including presence of gaps, discoloration, or ditching at restoration margins.
Baseline, 6 months, 9 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration retention and fracture resistance
Time Frame: Baseline, 6 months, 9 months, and 12 months
Evaluation of restoration survival, including retention and presence of fractures or chipping, according to FDI functional criteria.
Baseline, 6 months, 9 months, and 12 months
Postoperative sensitivity
Time Frame: Baseline, 6 months, 9 months, and 12 months
Assessment of patient-reported sensitivity following restoration placement, evaluated clinically using FDI biological criteria
Baseline, 6 months, 9 months, and 12 months
Recurrence of caries
Time Frame: Baseline, 6 months, 9 months, and 12 months
Detection of secondary caries associated with the restorations using clinical examination based on FDI criteria.
Baseline, 6 months, 9 months, and 12 months

Collaborators and Investigators

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

Sponsor

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)

March 1, 2025

Primary Completion (Actual)

March 17, 2026

Study Completion (Actual)

March 20, 2026

Study Registration Dates

First Submitted

March 22, 2026

First Submitted That Met QC Criteria

March 22, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Preheated composite Resin

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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