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OpenTrials
Completed

NCT Number: NCT03283280

Clinical Performance of Short Fiber Reinforced Resin Composite Versus Indirect Nanohybrid Resin Composite Onlay Restorations.

clinical performance of short fiber reinforced resin composite versus indirect nanohybrid resin composite onlay restorations in complex proximal cavities of molar teeth will be evaluated over one year.

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Key information

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, 11331, Egypt

About this study

Resin composite materials have been rapidly developed in the latest few years. Direct resin composite restorations become the golden standard for restoring intracoronal cavities. While for the extracoronal cavities, the indirect resin composite onlays tend to replace metallic restorations in most situations being more esthetic and conservative with lower cost (Rocca & Krejci, 2007).

Indirect resin composite onlays usually are lab processed in two appointments but it can be made in one appointment through CAD/CAM technology or by flexible model technique (semidirect technique).

These restorations offer more control on the proximal contacts and the anatomic form over the direct approach. Polymerization shrinkage occurs outside the patient mouth so the stresses are decreased and become limited to the width of the luting space. Annual failure rate (AFR) of indirect posterior resin composite restorations is up to 10% (Manhart et al, 2004).

One of the advancement in resin composite technology is the evolution of short fiber reinforced resin composite (SFRC) material that allows making a direct onlay restoration possible thus offers less procedural steps and saves more time (Garoushi et al, 2013).

This material is made to be used as a dentine substitute in the high stress-bearing areas. It is covered by a conventional resin composite filling to act as the enamel replacement this combination gives us a kind of biomimetic restoration.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pulp asymptomatic vital carious upper or lower molars.
  • Proximal complex carious cavities involving one or two weak cusps.
  • Replacement of old amalgam or resin composite restoration due to recurrent caries or either tooth or restoration fracture.
  • Presence of favorable occlusion.
  • Healthy volunteers

Exclusion criteria

  • Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
  • Deep subgingival cavity margins.
  • Possible future prosthodontic restoration of teeth.
  • Severe periodontal problems.
  • Medically compromised patients.

Treatment and study plan

Ever X Posterior

Other

Resin composite restoration can be made as a direct onlay

Other names: Short fiber reinforced resin composite

Primary outcomes

  1. Change in the Clinical performance

    Time frame: Change from the Baseline at six months and 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 Performance of Short Fiber Reinforced Resin Composite Restorations Versus Indirect Nanohybrid Resin Composite Onlay Restorations in Complex Proximal Cavities of Molars

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 14, 2017
Registry last updated
Jul 25, 2019

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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