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Clinical Performance of Fiber Reinforced Composite Versus Microhybrid Composite Restorations

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03515265
Collaborator
(none)
56
Enrollment
1
Location
2
Arms
14.3
Actual Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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 12 months using modified USPHS criteria.

Condition or Disease Intervention/Treatment Phase
  • Other: Fiber reinforced resin composite restoration
  • Other: Microhybrid resin composite restoration
 N/A

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.

Study Design

Study Type:
Interventional
Actual 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
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Feb 5, 2020
Actual Study Completion Date :
Mar 10, 2020

Arms and Interventions

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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Change in the Clinical performance [Change from the baseline at six months.]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry Giza Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Director: Mohamed Farid, PHD, Professor of Conservative Dentistry, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Sherifa Ahmed Abdelaziz Kandil, Assistant lecturer at Conservative Dentistry Department, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03515265
    Other Study ID Numbers:
    • CEBD-CU-2018-04-22
    First Posted:
    May 3, 2018
    Last Update Posted:
    Jan 27, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Assistant lecturer at Conservative Dentistry Department, Cairo University
    Fiber reinforced composite
    Microhybrid composite

    Study Results

    No Results Posted as of Jan 27, 2021