An observational study in Bruxism, Wear, Occlusal and Fracture, sponsored by Muğla Sıtkı Koçman University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by Muğla Sıtkı Koçman University · Observational
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.
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.
151 studies on the registry are indexed under Bruxism; 39 are open to participants now.
This study's enrollment of 80 is below the median of 89 across 55 observational studies indexed under Bruxism.
Browse Bruxism studies →Muğla Sıtkı Koçman University is the lead sponsor of 114 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Participants without bruxism and with PCR post-ETT were assigned to the control group.
Diagnostic Test: Bruxism diagnosis · Diagnostic Test: Clinical evaluation
The presence of bruxism was determined based on the participant's self-reported statements and intraoral findings.
The PCRs on the relevant teeth were evaluated according to the revised FDI criteria
Rate of Clinical success
FDI scoring system
Time frame: 1-5 years-follow up period
% of patients with risk factors
Clinical failure parameter
Time frame: 1-5 years-follow up period
Plan to share: Yes — sociodemographic characteristics and clinical findings
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Ran from Aug 2024 to primary completion in Jan 2025, 4 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Muğla Sıtkı Koçman University →