CompletedNot Applicable

Electromyographic Assessment of Sleep Bruxism in Patients With Stage III and IV Periodontitis

Italy40 participantsStarted 2025-06-27

Plain-language summary

This study aims to investigate the association between periodontitis Stage III and IV and the intensity and duration of sleep bruxism episodes. Surface electromyography (EMG) of the masseter muscle will be used to instrumentally assess sleep bruxism in patients with and without periodontal disease

Who can participate

Age range

28 Years – 50 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: * Age between 28 and 50 years * Ability to perform adequate oral hygiene * Willingness to participate and sign informed consent * For periodontitis group: Diagnosis of Stage III or IV periodontitis * For control group: Absence of periodontal disease Exclusion Criteria: * Use of removable dentures * Ongoing orthodontic treatment * Temporomandibular disorders (TMD) or orofacial pain * Use of medications affecting muscle activity * Systemic or psychiatric disorders * Diabetes

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

Sleep Bruxism Work Index (BWI)

Timeframe: Within 24 hours after EMG device application

Trial details

NCT IDNCT07053865

SponsorUniversity of Siena

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More Bruxism trials

Who can participate

Age range

28 Years – 50 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.