Clinical Performance of Fiber Reinforced Composite Versus Microhybrid Composite Restorations

Clinical Performance of Direct Fiber Reinforced Resin Composite Restorations Versus Direct Microhybrid Resin Composite Restorations in Endodontically Treated Molars: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Dental Restoration Failure of Marginal Integrity
• Intervention / Treatment: Other: Fiber reinforced resin composite restoration; Other: Microhybrid resin composite restoration

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Clinical performance	Measured using modified USPHS criteria for clinical evaluation of restoration failure.	Change from the baseline at six months.

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Abouelleil H, Pradelle N, Villat C, Attik N, Colon P, Grosgogeat B. Comparison of mechanical properties of a new fiber reinforced composite and bulk filling composites. Restor Dent Endod. 2015 Nov;40(4):262-70. doi: 10.5395/rde.2015.40.4.262. Epub 2015 Sep 2.

Helpful Links

• Fiber reinforced resin composite
• Microhybrid resin composite

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): February 5, 2020
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: April 20, 2018
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (Actual): May 3, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Fiber reinforced composite; Microhybrid composite
• Other Study ID Numbers: CEBD-CU-2018-04-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No