Effect of Bruxism on the Clinical Success of Posterior Composite Restorations

NCT06881355 | Completed

• 2 other identifiers: Brux-comp-1MSKU-Resto-Brux-comp-1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bruxism; Wear, Occlusal; Fracture

Keywords

Bruxism; Posterior composite restoration; Clinical success; Endodontically tretaed tooth

Outcome Measures

Primary Outcomes (1)

• Rate of Clinical success

  FDI scoring system

  1-5 years-follow up period

Secondary Outcomes (1)

• % of patients with risk factors

  1-5 years-follow up period

Study Arms (2)

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; Diagnostic Test: Clinical evaluation

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; Diagnostic Test: Clinical evaluation

Interventions

Bruxism diagnosis DIAGNOSTIC_TEST

The presence of bruxism was determined based on the participant's self-reported statements and intraoral findings.

Case group-Bruxists with PCR post-ETT; Control group-Non-bruxists with PCR post-ETT

Clinical evaluation DIAGNOSTIC_TEST

The PCRs on the relevant teeth were evaluated according to the revised FDI criteria

Case group-Bruxists with PCR post-ETT; Control group-Non-bruxists with PCR post-ETT

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Muğla Sıtkı Koçman University

Menteşe, Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (9)

• Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12.

  PMID: 36504246 BACKGROUND

• van de Sande FH, Opdam NJ, Rodolpho PA, Correa MB, Demarco FF, Cenci MS. Patient risk factors' influence on survival of posterior composites. J Dent Res. 2013 Jul;92(7 Suppl):78S-83S. doi: 10.1177/0022034513484337. Epub 2013 May 20.

  PMID: 23690354 BACKGROUND

• Manfredini D, Winocur E, Guarda-Nardini L, Paesani D, Lobbezoo F. Epidemiology of bruxism in adults: a systematic review of the literature. J Orofac Pain. 2013 Spring;27(2):99-110. doi: 10.11607/jop.921.

  PMID: 23630682 BACKGROUND

• R.R. Moraes, M.S. Cenci, J.R. Moura, F.F. Demarco, B. Loomans, N. Opdam, Clinical performance of resin composite restorations, Curr. Oral Health Rep.9 (2022) 22-31.

  BACKGROUND

• Hickel R, Manhart J. Longevity of restorations in posterior teeth and reasons for failure. J Adhes Dent. 2001 Spring;3(1):45-64.

  PMID: 11317384 BACKGROUND

• Laske M, Opdam NJM, Bronkhorst EM, Braspenning JCC, Huysmans MCDNJM. Risk Factors for Dental Restoration Survival: A Practice-Based Study. J Dent Res. 2019 Apr;98(4):414-422. doi: 10.1177/0022034519827566. Epub 2019 Feb 20.

  PMID: 30786222 BACKGROUND

• Kramer N, Reinelt C, Frankenberger R. Ten-year Clinical Performance of Posterior Resin Composite Restorations. J Adhes Dent. 2015 Aug;17(5):433-41. doi: 10.3290/j.jad.a35010.

  PMID: 26525008 BACKGROUND

• Koyano K, Tsukiyama Y, Ichiki R, Kuwata T. Assessment of bruxism in the clinic. J Oral Rehabil. 2008 Jul;35(7):495-508. doi: 10.1111/j.1365-2842.2008.01880.x.

  PMID: 18557916 BACKGROUND

• Yilmaz F, Dorterler OC. Effect of Bruxism on the Clinical Success of Posterior Composite Restorations in Endodontically Treated Teeth: A Cross-Sectional, Case-Control Study. J Esthet Restor Dent. 2025 Oct;37(10):2180-2192. doi: 10.1111/jerd.70008. Epub 2025 Jul 27.

  PMID: 40717393 DERIVED

MeSH Terms

Conditions

Bruxism; Tooth Attrition; Fractures, Bone

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior; Tooth Wear; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor Doctor

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 18, 2025
• Study Start: August 15, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 30, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)