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Bruxism Therapy of Facial Pain

RecruitingNAAges 18 Years - anyAllFondazione Policlinico Universitario Agostino Gem…
NCT07611643 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult subjects aged ≥ 18 years * Subjects willing to provide written informed consent * Patients with temporomandibular disorders who have an indication for treatment with a gnathological occlusal splint Exclusion Criteria: * Patients who change their pharmacological regimen during the monitoring period, as drug therapy may affect facial pain and/or muscle activity.
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What it tests

  • Electromyographic analysis of the masseter muscle using the Diabruxo® device (Biotech-Novations, Sanremo, Italy).
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Where

1 site
Clinica Odontostomatologica - Fondazione Policlinico IRCSS A. Gemelli
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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