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Bruxism Therapy of Facial Pain
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Summary
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.
Official title: Effect of Therapy for Myofascial Facial Pain on Bruxism/Nocturnal Clenching. Prospective, Non-profit Interventional Study Using a Device.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2026-01-12
Completion Date
2027-01-10
Last Updated
2026-05-28
Healthy Volunteers
Yes
Interventions
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.
Locations (1)
Clinica Odontostomatologica - Fondazione Policlinico IRCSS A. Gemelli
Roma, Roma, Italy