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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07496047
Enrollment
70
Registered
2026-03-27
Start date
2025-03-01
Completion date
2026-03-20
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Composite Resins, Composite Restoration, Restoration Design, Teeth Sensitivity

Keywords

Short fiber-reinforced composite, preheating, Class I cavities, FDI criteria, randomized clinical trial

Brief summary

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

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

Interventions

OTHERPreheated 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.

OTHERNon-preheated everX Posterior composite

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Marginal adaptationBaseline, 6 months, 9 months, and 12 monthsAssessment of the marginal integrity of restorations using FDI criteria, including presence of gaps, discoloration, or ditching at restoration margins.

Secondary

MeasureTime frameDescription
Restoration retention and fracture resistanceBaseline, 6 months, 9 months, and 12 monthsEvaluation of restoration survival, including retention and presence of fractures or chipping, according to FDI functional criteria.
Postoperative sensitivityBaseline, 6 months, 9 months, and 12 monthsAssessment of patient-reported sensitivity following restoration placement, evaluated clinically using FDI biological criteria
Recurrence of cariesBaseline, 6 months, 9 months, and 12 monthsDetection of secondary caries associated with the restorations using clinical examination based on FDI criteria.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026