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Completed

NCT Number: NCT07496047

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

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

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Key information

Conditions

Composite Resins Composite Restoration Dentin Sensitivity Restoration Design Stomatognathic Diseases Teeth Sensitivity Tooth Diseases

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preheated everX Posterior composite

Other

Application of everX Posterior composite after preheating to 54°C using a composite warmer, followed by placement, adaptation, and curing according to manufacturer guidelines.

Non-preheated everX Posterior composite

Other

Application of everX Posterior composite at room temperature, placed and cured according to manufacturer instructions.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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