Bruxism Therapy of Facial Pain

NCT07611643 | Recruiting

• 1 other identifier: 7906
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bruxism; Bruxism, Sleep-Related; Sleep Quality

Outcome Measures

Primary Outcomes (1)

• Bruxism Personal Index (BPI) as Assessed by 24-Hour Electromyography (EMG) in TMD patients

  The BPI index (n) represents the level of masseter muscle activity recorded continuously over a 24-hour period using the validated portable dia-BRUXO® device.

  Baseline (before splint use), 2 weeks after splint delivery, and 2 months after initiation of treatment.

Study Arms (1)

Intervention arm (gnathological occlusal splint)

EXPERIMENTAL

Adult patients with temporomandibular disorders and chronic myofascial pain of the masticatory muscles treated with a night-time gnathological occlusal splint, with assessment of masticatory muscle electromyographic activity using the dia-BRUXO® device at baseline, after 2 weeks, and after 2 months of splint use. In addition, there is an observational control group consisting of healthy subjects without temporomandibular disorders, included for comparison purposes only and not considered an interventional arm, as no treatment is administered.

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

Interventions

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

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.

Intervention arm (gnathological occlusal splint)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who change their pharmacological regimen during the monitoring period, as drug therapy may affect facial pain and/or muscle activity.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Clinica Odontostomatologica - Fondazione Policlinico IRCSS A. Gemelli

Roma, Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Bruxism; Sleep Bruxism; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: May 28, 2026
• Study Start: January 12, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): January 10, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

IT (1)