CompletedNot Applicable

Effect of Bruxism on the Clinical Success of Posterior Composite Restorations

Turkey (Türkiye)80 participantsStarted 2024-08-15

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of Clinical success

Timeframe: 1-5 years-follow up period

Trial details

NCT IDNCT06881355

SponsorMuğla Sıtkı Koçman University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-01

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