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NCT03515265 Clinical Trial

Clinical Performance of Fiber Reinforced Composite Versus Microhybrid Composite Restorations

Dental Restoration Failure of Marginal Integrity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03515265
Other study ID # CEBD-CU-2018-04-22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date March 10, 2020

Study information
Verified date January 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date March 10, 2020
Est. primary completion date February 5, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

  • Dental Restoration Failure of Marginal Integrity

Intervention

Other:
• Fiber reinforced resin composite restoration
a type of resin composite with improved strength due to the fiber's action
• Microhybrid resin composite restoration
a type of conventional resin composite

Locations
Country Name City State
Egypt Faculty of Dentistry Giza

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

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