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RECRUITING
NCT07875738

Effect Of Orofacial Pain Therapy On Bruxism

Sponsor: Catholic University of the Sacred Heart

View on ClinicalTrials.gov

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.

Official title: Effetto Della Terapia Per Il Dolore Facciale Miofasciale Sul Bruxismo/Serramento

Key Details

Gender

All

Age Range

18 Years - 79 Years

Study Type

OBSERVATIONAL

Enrollment

42

Start Date

2026-01-16

Completion Date

2027-09-30

Last Updated

2026-10-15

Healthy Volunteers

Yes

Locations (1)

Università Cattolica del Sacro Cuore

Roma, Italy