Effect of Bruxism on the Clinical Success of Posterior Composite Restorations (Bruxism)

March 11, 2025 updated by: Fatma Yilmaz, Muğla Sıtkı Koçman University

Effect of Bruxism on the Clinical Success of Posterior Composite Restorations in Endodontically Treated Teeth: A Cross-sectional, Case-Control Study

The goal of this study is to determine the effect of bruxism on the success of posterior composite restorations (PCRs) in endodontically treated teeth (ETT). The null hypotheses of present study were as follows: (1) bruxism would not have a significant effect on the success rate of PCRs in ETT; (2) other demographic and clinical variations, such as frequency of coloring agent usage, smoking habits, presence of pulpal pathology, periapical lesion, periodontal condition, antagonist tooth condition, cavity margin level, quality of endodontic treatment, enamel cracks, temporomandibular joint (TMJ) disorders, lateral occlusion scheme, institution where the restoration was performed, number of restored surfaces, and follow-up period, would not have a significant effect on the success rate of PCRs in ETT; and (3) functional, esthetic, and biological clinical success of PCRs of bruxists would not differ from that of non-bruxists. This cross-sectional, case-control study included 40 case patients (bruxists with PCR post-ETT) and 40 controls (non-bruxists). Sociodemographic characteristics and clinical findings were recorded. The PCRs on the relevant teeth were evaluated according to the revised FDI criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In studies that have conducted long-term follow-ups of posterior composite restorations (PCRs), the most common causes of failure are secondary caries, wear, and fractures. The success of PCRs is influenced by several factors: oral hygiene habits, caries risk, size of the carious lesion, occlusal relationships, presence of parafunctional habits, physical properties of the material used, tooth region in which the restoration is placed, size and location of the restoration, and chewing habits and forces. In addition, the literature suggests that PCRs have a low wear resistance. While this characteristic is considered to offer an advantage in the presence of parafunctional habits, its effect on the success of PCRs under excessive occlusal stress remains a subject of debate. There are many prospective and retrospective studies evaluating the performance of restorations; however, literature on the success of composite resin materials when applied as direct restorations of ETT in patients with bruxism is limited. Furthermore, with the continuous development and introduction of new adhesive techniques and improvements in the composition of composite resin materials, clinical studies need to be updated regularly to assess the performance of restorations.

Study Type

Observational

Enrollment (Actual)

80

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
    • Muğla
      • Menteşe, Muğla, 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

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

In this study, the initial data pool consists of patients who had undergone their first examination and had the necessary radiographs taken routinely. After clinically and radiographically identifying those who had underwent root canal treatment and composite restorations, the eligible participants were included in the study to evaluate their restorations.

Description

Inclusion Criteria:

  • Patients aged 18-40 years, PCRs after endodontic treatment,
  • Restorations up to 5 years,
  • Class 1 and 2 restorations with a maximum of 3 wall loss according to cavity classification and not involving the cusps,
  • Patients with low and moderate caries risk, and those with an occlusion classified as Class 1 Angle.

Exclusion Criteria:

  • Teeth without antagonists;
  • patients with crossbite; mobile teeth;
  • teeth diagnosed with acute apical/periodontal abscess;
  • presence of severe periodontal disease;
  • presence of systemic diseases;
  • pregnant and breastfeeding women;
  • patients who had amalgam, post, or indirect methods chosen for definitive restoration after endodontic treatment;
  • restorations performed more than 5 years ago;
  • patients aged <18 or >40 years;
  • restorations involving the cusps,
  • patients with high caries risk, and non-dental plaque biofilm-induced gingival diseases.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case group-Bruxists with PCR post-ETT
Participants having previously undergone endodontic treatment and composite restorations on any of their posterior teeth and bruxism were assigned to the case group. The presence of bruxism was determined based on the participant's self-reported statements and intraoral findings.
Diagnostic test: Bruxism diagnosis
The presence of bruxism was determined based on the participant's self-reported statements and intraoral findings.
Diagnostic test: Clinical evaluation
The PCRs on the relevant teeth were evaluated according to the revised FDI criteria
Control group-Non-bruxists with PCR post-ETT
Participants without bruxism and with PCR post-ETT were assigned to the control group.
Diagnostic test: Bruxism diagnosis
The presence of bruxism was determined based on the participant's self-reported statements and intraoral findings.
Diagnostic test: Clinical evaluation
The PCRs on the relevant teeth were evaluated according to the revised FDI criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Clinical success
Time Frame: 1-5 years-follow up period
FDI scoring system
1-5 years-follow up period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients with risk factors
Time Frame: 1-5 years-follow up period
Clinical failure parameter
1-5 years-follow up period

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)

August 15, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 11, 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 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Brux-comp-1
  • MSKU-Resto-Brux-comp-1 (Other Identifier: MSKU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

sociodemographic characteristics and clinical findings

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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