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Completed

NCT Number: NCT05380973

Clinical Performance of Two Fiber Reinforced Resin Composites Versus Nanohybrid Resin Composite in Posterior Teeth Will be Evaluated Using Modified USPHS Criteria

This study is conducted to evaluate the clinical performance of two fiber-reinforced resin composite restorations compared to nanohybrid resin composite restorations in patients with posterior MOD cavities

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry-Cairo university

Cairo, Egypt

About this study

Statement of the problem:

With limited evidence based information in literature about using fiber-reinforced composite (FRC) restorations in stress bearing posterior areas, it is beneficial to evaluate the newly introduced materials using a randomized clinical trial to test the null hypothesis that this new material "fiber reinforced resin composites" will have the same clinical performance as the nanohybrid resin composite restoration in such situation

Rationale:

Improvements concerning the esthetic and mechanical properties of dental resin composites have resulted in widespread use of these materials in both anterior and posterior teeth. However, resin composites still have a number of limitations in posterior teeth, mainly because of problems related to technique sensitivity, polymerization shrinkage and low fracture resistance, Due the failures of this kind, it is still controversial, whether restorative composites should be used in large high-stress bearing applications such as in direct posterior restorations.

Fiber-reinforcement of resin-based composite restorations has been proposed to increase resistance of materials fracturing under high stress-bearing cavities. Fiber-reinforced composite (FRC) is made of a polymer matrix, impregnated with fibers. The fibers allow the stresses to be distributed throughout the restoration. Since the role of the fibers is to improve the structura lproperties of the material by acting as crack stoppers, the FRC framework provides strength and rigidity of the composite materials.

The common types of fibers used in dentistry are glass and polyethylene fibers. Composite resin reinforced with short E-glass fiber fillers showed substantial improvements in the load bearing capacity, the flexural strength and fracture toughness of in comparison with conventional particulate filler restorative composite resin. The short fiber composite resin has also revealed control of the polymerization shrinkage stress by fiber orientation and, thus, marginal microleakage was reduced compared with conventional particulate filler restorative composite resins.

Polyethylene fibers are one of the most durable reinforcing fibers available. They are made of aligned polymer chains, having low modulus and density, and presents good impact resistance.They are white in colour and thus it is possible to use them in aesthetic dental applications, the use of polyethylene fiber ribbon in combination with bonding agent and flowable composite under composite restoration may act as a stress absorber because of its lower elastic modulus thereby increasing fracture resistance

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • MOD carious lesions premolars and molars.
  • Vital upper or lower teeth with no signs of irreversible pulpitis.
  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion criteria

  • Deep carious defects (close to pulp, less than 1 mm distance).
  • Periapical pathology or signs of pulpal pathology.
  • Endodontically treated teeth.
  • Tooth hypersensitivity.
  • Possible prosthodontic restoration of teeth.
  • Heavy occlusion and occlusal contacts or history of bruxism
  • Severe periodontal affection.

Treatment and study plan

Short fiber resin composite

Other

resin composite reinforced with short glass fibers

Other names: (Ever X Posterior, GC, Japan)

Polyethylene ribbon fiber

Other

resin composite reinforced with polyethylene ribbon fiber

Other names: (Ribbond Inc., Seattle, WA, USA)

Primary outcomes

  1. Change in the clinical performance

    Time frame: Change from the baseline at 12 months.

    Measured using modified USPHS criteria for clinical evaluation of restoration failure.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Evaluation of Two Fiber Reinforced Resin Composites Versus Nanohybrid Resin Composite in Posterior Restorations: Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 19, 2022
Registry last updated
Nov 26, 2024

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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