Evaluation of the Clinical Success of Direct Restorations of Endodontically Treated Posterior Teeth in the Presence of Parafunction: A Pilot Study (Fibre)

March 5, 2025 updated by: Fatma Yilmaz, Muğla Sıtkı Koçman University

The aim of this prospective, randomized, parallel-group clinical study is to compare the 6- and 12-month clinical performances of direct composite restorations applied to endodontically treated posterior teeth with or without the use of fiber-reinforced composite material in individuals with parafunctional habits.

Bruxism is a repetitive jaw-muscle activity characterized by clenching and/or grinding of teeth. The possible outcomes of bruxism include wear and/or fractures in the teeth and restorations. Therefore, the choice of restorative methods and materials for restorations in bruxist individuals is of great importance. Direct adhesive restorations are the first treatment option for endodontically treated teeth with no excessive material loss and/or those that have lost vitality due to trauma. Over the past decade, the use of fiber-reinforced materials has been recommended to prevent catastrophic fractures. Fiber-reinforced materials have been developed and introduced to the market based on the idea that a restorative material that distributes or absorbs stress in high-stress areas will protect the underlying tooth structure.

Although there are numerous studies on the mechanical durability of restorative treatments for endodontically treated teeth in cases with parafunctional habits, there are limited clinical studies regarding the clinical performance of these methods.

The study included 32 premolar or molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were divided into two groups (n=16): Group 1: fiber-reinforced composite restoration (EverX flow, GC) (FRCR), Group 2: composite restoration (Gneal Posterior, GC) (CR). The restorations were evaluated at 6 and 12 months using the FDI criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Mugla
      • Mentese, Mugla, Turkey, 48000
        • Muğla Sıtkı Koçman University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteers aged 18 and above Cases where restoration was performed immediately after the completion of root canal treatment on posterior teeth Endodontically treated posterior teeth that required replacement of the old restoration due to secondary caries or fractures Cases without pulpal symptoms Posterior teeth classified as Class 1 and Class 2 according to cavity classification Teeth with a remaining wall thickness of at least 3 mm Presence of parafunction Teeth with a natural tooth in the opposing arch and adjacent teeth on both proximal sides

Exclusion Criteria:

  • Individuals who are not volunteers
  • Cases with ongoing pulpal symptoms
  • Posterior teeth with cusp loss
  • Teeth with root canal filling that is at least 2 mm shorter than the radiographic apex
  • Individuals unable to attend periodic follow-up visits
  • Individuals with a Gingival Index score greater than 1
  • Severe periodontal disease
  • Presence of systemic diseases
  • Individuals with allergic reactions to any of the materials to be used
  • Pregnant or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fiber-reinforced composite restoration (FRCR)
After the cavity preparation, an adhesive was applied to the tooth, and a short fiber-reinforced flowable composite resin (EverX flow, GC) was used as the dentin replacement material. It was then covered with posterior composite resin (Gneal Posterior, GC).
Other: Composite Restoration
The study included premolar or molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were divided into two groups: Group 1: fiber-reinforced composite restoration (FRCR), Group 2: composite restoration (CR). Direct composite restorations with or without fiber reinforced material were applied. The restorations were evaluated at 6 and 12 months using the FDI criteria.
Other: Clinical evaluation
The restorations were evaluated by two experienced and fully blinded observers according to the functional, esthetic, and biological criteria. The criteria were scored from 1 to 5 (sufficient/acceptable= score 1 to 3, insufficient/inacceptable but repair possible= score 4, and insufficient/inacceptable but repair not possible/reasonable= score 5). Scores of 4 and 5 were considered as failure in the restoration.
Experimental: Composite restoration (CR)
After the cavity preparation, an adhesive was applied to the tooth, and only posterior composite resin material (Gneal Posterior, GC) was used for filling whole of the cavity
Other: Composite Restoration
The study included premolar or molar teeth with Class 1 and Class 2 cavity types and a remaining wall thickness of at least 3 mm, which had undergone endodontic treatment from volunteer participants. The teeth randomly assigned were divided into two groups: Group 1: fiber-reinforced composite restoration (FRCR), Group 2: composite restoration (CR). Direct composite restorations with or without fiber reinforced material were applied. The restorations were evaluated at 6 and 12 months using the FDI criteria.
Other: Clinical evaluation
The restorations were evaluated by two experienced and fully blinded observers according to the functional, esthetic, and biological criteria. The criteria were scored from 1 to 5 (sufficient/acceptable= score 1 to 3, insufficient/inacceptable but repair possible= score 4, and insufficient/inacceptable but repair not possible/reasonable= score 5). Scores of 4 and 5 were considered as failure in the restoration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical success
Time Frame: 6 and 12 months-follow-up
The restorations were evaluated by two experienced and fully blinded observers according to the functional, esthetic and biological criteria according to the FDI criteria. The criteria were scored from 1 to 5 (sufficient/acceptable= score 1 to 3, insufficient/inacceptable but repair possible= score 4, and insufficient/inacceptable but repair not possible/reasonable= score 5). Scores of 4 and 5 were considered as failure in the restoration.
6 and 12 months-follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muğla Sıtkı Koçman University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Actual)

February 21, 2025

Study Completion (Actual)

February 25, 2025

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fiber-reinforced-comp-pilot
  • 23/152/02/3/4 (Other Grant/Funding Number: SCIENTIFIC RESEARCH PROJECTS COORDINATION UNIT OF MUĞLA SITKI KOÇMAN UNIVERSITY RECTORATE)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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