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

Clinical Performance of Short Fiber Reinforced Resin Composite Restorations Versus Indirect Nanohybrid Resin Composite Onlay Restorations in Complex Proximal Cavities of Molars

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.

Study Overview

• Status: Completed
• Conditions: Dental Restoration Failure of Marginal Integrity
• Intervention / Treatment: Other: Ever X Posterior

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11331
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Resin composite restoration can be made as a direct onlay; Other Names: Short fiber reinforced resin composite
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; Resin composite restoration can be made as a direct onlay; Other Names: Short fiber reinforced 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 and 12 months.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Rawda Hesham Abd ElAziz, Msc, Assistant lecturer

Publications and helpful links

Helpful Links

• Short fiber reinforced resin composite
• Indirect nanohybrid resin composite

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Short fiber reinforced resin composite; Nanohybrid resin composite; Indirect resin composite restoration
• Other Study ID Numbers: CEBD-CU-10-9-2017

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