An observational study in Masticatory Myofascial Pain, sponsored by Catholic University of the Sacred Heart. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Catholic University of the Sacred Heart · Observational
Bruxism and clenching at night and during the day are considered the most common parafunctions that can influence temporomandibular disorders, including chronic myofascial pain of the masticatory muscles. When bruxism and/or clenching are present, treatment generally includes the use of a gnathological splint at night. According to the International Consensus on Bruxism, a definitive diagnosis of bruxism/clenching requires an instrumental assessment consisting of an electromyographic recording of masticatory muscle activity. In this regard, over the past four years, an Italian company (Biotech-Novations, Sanremo, Italy) has created a portable device (dia- BRUXO) to be worn for 24 hours (day and night) that measures muscle activity in the oral region. The company has established baseline cut-off values for daytime and nighttime muscle activity. The aim of the study is to investigate the effectiveness of using gnathological splints in reducing bruxism and clenching during wakefulness and sleep in adults with chronic myofascial pain.
Catholic University of the Sacred Heart is the lead sponsor of 237 studies on the registry; 29 are open to participants now.
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adults patients with chronic masticatory myofascial pain
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Exclusion criteria:
- Patients who change their medication regimen during the monitoring period because pharmacological therapy may affect facial pain and/or muscle activity.
effectiveness of gnathological splints on bruxism during wakefulness and sleep in adults with myofascial pain, measured through EMG values obtained by dia-BRUXO device. During treatment EMG values will be compared for each subject to pre-treatment EMG
EMG-recorded masticatory muscle activity will be collected using the dia-BRUXO device; which is a tool to diagnose bruxism and clenching both during wakefulness and sleep. patients with chronic myfascial pain will undergo dia-BRUXO registration at baseline and 2 months after receiving a gnathological splint (the regular treatment for bruxism) for night time use. changes will be compared between pre and during treatment. a control group of subjects without pain will undergo the same registrations at 2 months distance, without splint use.
Time frame: 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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