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Clinical Trials/NCT03283280
NCT03283280
Completed
Not Applicable

Clinical Performance of Short Fiber Reinforced Resin Composite Restorations Versus Indirect Nanohybrid Resin Composite Onlay Restorations in Complex Proximal Cavities of Molars

Cairo University1 site in 1 country76 target enrollmentStarted: February 1, 2018Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
76
Locations
1
Primary Endpoint
Change in the Clinical performance

Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

The outcome assessors will be blinded to the material type

Eligibility Criteria

Ages
16 Years to 55 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rawda Hesham Abd ElAziz

Assistant lecturer

Cairo University

Study Sites (1)

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