An interventional study of Electromyographic analysis of the masseter muscle using the Diabruxo® device (Biotech-Novations, Sanremo, Italy). in Bruxism, Bruxism, Sleep-Related and Sleep Quality, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Diagnostic
This prospective, non-profit study aims to better understand how occlusal splints (gnathological splints) affect daytime and nighttime bruxism (teeth grinding) and clenching in adults with chronic myofascial pain of the jaw muscles, a common form of temporomandibular disorder (TMD). Bruxism and clenching are repetitive or sustained jaw muscle activities that can contribute to jaw pain and dysfunction, and their accurate diagnosis requires instrumental assessment of muscle activity. In this study, muscle activity will be objectively measured using a portable device (dia-BRUXO®) worn for 24 hours, which records the electrical activity of the chewing muscles during both wakefulness and sleep. Adult patients with TMD who are prescribed a night-time occlusal splint will undergo three 24-hour recordings: before using the splint, two weeks after starting treatment, and two months later. During each recording, participants will also report their facial pain levels and awareness of clenching or grinding during the day. Their results will be compared with those of a matched control group without TMD. The main goal is to compare jaw muscle activity between patients and healthy individuals, while secondary goals include analyzing how long the muscles are active and how these patterns relate to symptoms. By combining objective measurements and patient-reported experiences, this study seeks to clarify how occlusal splints influence muscle activity and symptoms, helping clinicians improve diagnosis and treatment of bruxism and TMD.
This prospective, non-profit interventional study is designed to evaluate the effects of a gnathological occlusal splint on masticatory muscle activity in adults with temporomandibular disorders (TMD) and chronic myofascial pain. Bruxism and clenching, occurring during both wakefulness and sleep, are recognized contributors to TMD symptoms and are best assessed through instrumental measurement. For this purpose, the study uses a validated portable device (dia-BRUXO®) capable of recording the electromyographic (EMG) activity of the masseter muscles continuously over a 24-hour period, allowing objective assessment of muscle activity during daily life and sleep.
Participants with TMD who have a clinical indication for nocturnal occlusal splint therapy will undergo three 24-hour EMG recordings: at baseline (before splint use), two weeks after splint delivery, and two months after initiation of treatment. During each recording period, participants will also self-report facial pain intensity and awareness of parafunctional activities at regular intervals during wakefulness. EMG outcomes will include average signal amplitude, muscle activation time, and the presence of abnormal co-contraction patterns. These data will be used to assess changes in muscle activity over time and in relation to splint use.
A control group of age- and sex-matched adults without TMD will undergo two 24-hour EMG recordings, two months apart, following the same recording and self-report procedures. Comparisons between the TMD group and controls will allow identification of functional differences in masticatory muscle activity. The primary endpoint is the comparison of masseter muscle EMG activity between participants with TMD and healthy controls, while secondary endpoints include analysis of muscle activation duration and correlations between EMG patterns and reported symptoms. This integrated approach aims to improve understanding of the functional impact of occlusal splints and support more objective diagnosis and management of bruxism and TMD.
62 studies on the registry are indexed under Sleep Bruxism; 11 are open to participants now.
This study's planned enrollment of 42 is close to the median of 39 across 38 interventional studies indexed under Sleep Bruxism.
Browse Sleep Bruxism studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Compared within Sleep Bruxism, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Bruxism. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with temporomandibular disorders and chronic myofascial pain of the masticatory muscles treated with a night-time gnathological occlusal splint, with assessment of masticatory muscle electromyographic activity using the dia-BRUXO® device at baseline, after 2 weeks, and after 2 months of splint use. In addition, there is an observational control group consisting of healthy subjects without temporomandibular disorders, included for comparison purposes only and not considered an interventional arm, as no treatment is administered.
Device: Electromyographic analysis of the masseter muscle using the Diabruxo® device (Biotech-Novations, Sanremo, Italy).
Enrolled participants will be adults with chronic myofascial pain of the masticatory muscles who have a clinical indication for nocturnal treatment with a gnathological occlusal splint. Patients who agree to undergo this therapy for their initial diagnosis will be invited to participate in the study. After providing written informed consent, participants will be given the Diabruxo® device and instructed to perform a 24-hour recording. During device use, patients will be asked to record, on five occasions during wakefulness (every three hours), their level of facial pain and any awareness of parafunctional activities. Following the baseline recording, participants will receive the gnathological occlusal splint and will undergo additional 24-hour recordings two weeks after splint delivery and again two months later, for a total of three recordings per participant. During each recording session, the same self-report measures of facial pain and awareness of parafunctions will be collected.
Bruxism Personal Index (BPI) as Assessed by 24-Hour Electromyography (EMG) in TMD patients
The BPI index (n) represents the level of masseter muscle activity recorded continuously over a 24-hour period using the validated portable dia-BRUXO® device.
Time frame: Baseline (before splint use), 2 weeks after splint delivery, and 2 months after initiation of treatment.
Ran from Jan 2026 to primary completion in Jun 2026, 4 months.
Of 19 interventional studies with no phase under Sleep Bruxism, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's 4 months is below that.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS →