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Recruiting NCT07875738

Effect Of Orofacial Pain Therapy On Bruxism

Conditions: Masticatory Myofascial Pain

Sex: All
Ages: 18 Years – 79 Years
Healthy volunteers: Yes
Enrollment: 42
Sponsor: Catholic University of the Sacred Heart

Location: Università Cattolica del Sacro Cuore Roma

Summary

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.

Eligibility Criteria

Inclusion criteria: * Adult subjects * Subjects who agree to sign the informed consent form * Patients with temporomandibular dysfunction who are indicated for treatment with a gnathological splint Exclusion criteria: \- Patients who change their medication regimen during the monitoring period because pharmacological therapy may affect facial pain and/or muscle activity.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07875738). StuddyBuddy aggregates publicly available trial information.