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Clinical Performance of Fiber Reinforced Composite Versus Microhybrid Composite Restorations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03515265
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : July 25, 2019
Information provided by (Responsible Party):
Sherifa Ahmed Abdelaziz Kandil, Cairo University

Brief Summary:
Clinical performance of direct fiber reinforced resin composite restorations versus direct microhybrid resin composite restorations in endodontically treated molars will be evaluated over 6 months using modified USPHS criteria.

Condition or disease Intervention/treatment Phase
Dental Restoration Failure of Marginal Integrity Other: Fiber reinforced resin composite restoration Other: Microhybrid resin composite restoration Not Applicable

Detailed Description:

Restoration of endodontically treated teeth is one of the main challenges in restorative dentistry. There are structural changes in endodontically treated tooth: dehydration of dentin, mutation of collagen due to the effect of irrigation and reduction of hardness. This alteration together with loss of tooth structure inflicts a negative impact on long term prognosis of the endodontically treated tooth increases incidence of dental fracture.

Endodontically treated teeth were restored traditionally by crown but this approach is invasive with many technical and clinical steps that prolong the time of treatment. Adhesive philosophy and resin composite were developed and enhanced within the last thirty years that give clinician conservative option also strengthen, protect the tooth against fracture and changed the doctrine of devitalized tooth must be restored by crown. Current studies encourage applying conservative approach and restoring endodontically treated teeth with bonded restorations, so a lot of classic indications of crown in restoring endodontically treated teeth are questioned now.

Microhybrid resin composite restorations permit application of conservative approach that preserves remaining sound tooth structure. Fiber reinforced resin composite improved strength, toughness and fracture resistance of conventional resin composite and restored teeth.

Fiber reinforcement of conventional resin composite is introduced aiming to improve their physical, mechanical properties and tooth fracture resistance. The improvement of the properties was interpreted due to the rule of fibers in stopping crack propagation and transferring stress from matrix to fibers, also it was suggested that fiber Reinforced Resin Composites decrease polymerization shrinkage and shrinkage stress. fiber-reinforced resin composites are used as a dentine substitute combined with conventional resin composites as an enamel replacement.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Performance of Direct Fiber Reinforced Resin Composite Restorations Versus Direct Microhybrid Resin Composite Restorations in Endodontically Treated Molars: A Randomized Clinical Trial
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : July 5, 2020
Estimated Study Completion Date : October 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: Fiber resin composite
Fiber reinforced resin composite restoration used as dentin substitute covered by conventional resin composite
Other: Fiber reinforced resin composite restoration
a type of resin composite with improved strength due to the fiber's action
Other Name: Ever X posterior

Active Comparator: Microhybrid resin composite
Microhybrid resin composite restoration with lower strength compared to Fiber reinforced resin composite restoration
Other: Microhybrid resin composite restoration
a type of conventional resin composite

Primary Outcome Measures :
  1. Change in the Clinical performance [ Time Frame: Change from the baseline at six months. ]
    Measured using modified USPHS criteria for clinical evaluation of restoration failure.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with Good oral hygiene.
  • Co-operative patients approving to participate in the study.
  • Endodontically treated molar with minimum to moderate loss of tooth structure.
  • Presence of antagonists

Exclusion Criteria:

  • Patients with advanced periodontal disease.
  • Patients with parafunctional habits.
  • Patients with temporomandibular joint disorders.
  • Teeth with failed endodontic therapy or extensive caries.
  • Pregnant female

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03515265

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Contact: Sherifa Kandil, Master 1003605338 ext +20
Contact: Shereen Ibrahim, PHD 1099296591 ext +20

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Faculty of Dentistry Recruiting
Giza, Egypt
Sponsors and Collaborators
Cairo University
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Study Director: Mohamed Farid, PHD Professor of Conservative Dentistry, Cairo University

Additional Information:
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Responsible Party: Sherifa Ahmed Abdelaziz Kandil, Assistant lecturer at Conservative Dentistry Department, Cairo University Identifier: NCT03515265     History of Changes
Other Study ID Numbers: CEBD-CU-2018-04-22
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sherifa Ahmed Abdelaziz Kandil, Cairo University:
Fiber reinforced composite
Microhybrid composite