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CompletedNCT03283280Updated Jul 25, 2019

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

An interventional study of Ever X Posterior in Dental Restoration Failure of Marginal Integrity, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 16 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-25.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
16 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dental Restoration Failure of Marginal Integrity

Keywords

  • Short fiber reinforced resin composite
  • Nanohybrid resin composite
  • Indirect resin composite restoration
03

Who can participate

Ages eligible
16 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
  2. Deep subgingival cavity margins.
  3. Possible future prosthodontic restoration of teeth.
  4. Severe periodontal problems.
  5. Medically compromised patients.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    Short fiber RC

    Short fiber reinforced resin composite restoration (Ever X Posterior, Gc Europe) that is used in high stress bearing areas as direct onlay restoration.

    Other: Ever X Posterior

  • Active comparator
    Nanohybrid RC

    Nanohybrid resin composite (GrandioSO, VOCO GmbH Germany ) that can be used to make indirect restorations in posterior teeth.

    Other: Ever X Posterior

Interventions

  • OtherEver X Posterior

    Resin composite restoration can be made as a direct onlay

    Also known as: Short fiber reinforced resin composite

05

What researchers measure

Primary outcomes

  1. Change in the Clinical performance

    Measured using modified USPHS criteria for clinical evaluation of restoration failure

    Time frame: Change from the Baseline at six months and 12 months.

06

Study locations

1 site
  • Faculty of Dentistry
    Cairo, 11331, Egypt
07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03283280
Lead sponsor
Cairo University
Responsible party
Rawda Hesham Abd ElAziz (Assistant lecturer, Cairo University) — Principal investigator
First posted
Sep 14, 2017
Start date
Feb 1, 2018
Primary completion
Jun 1, 2019
Completion
Jul 1, 2019
Last update
Jul 25, 2019

Study contacts

Rawda Hesham Abd ElAziz, Msc
principal investigator · Assistant lecturer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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