Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT07611643

Bruxism Therapy of Facial Pain

Conditions: Bruxism, Bruxism, Sleep-Related, Sleep Quality

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 42
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Location: Clinica Odontostomatologica - Fondazione Policlinico IRCSS A. Gemelli Roma Roma

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07611643). StuddyBuddy aggregates publicly available trial information.