Bruxism Therapy of Facial Pain (BRUXI)

May 20, 2026 updated by: Gallenzi Patrizia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Effect of Therapy for Myofascial Facial Pain on Bruxism/Nocturnal Clenching. Prospective, Non-profit Interventional Study Using a Device.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, non-profit interventional study is designed to evaluate the effects of a gnathological occlusal splint on masticatory muscle activity in adults with temporomandibular disorders (TMD) and chronic myofascial pain. Bruxism and clenching, occurring during both wakefulness and sleep, are recognized contributors to TMD symptoms and are best assessed through instrumental measurement. For this purpose, the study uses a validated portable device (dia-BRUXO®) capable of recording the electromyographic (EMG) activity of the masseter muscles continuously over a 24-hour period, allowing objective assessment of muscle activity during daily life and sleep.

Participants with TMD who have a clinical indication for nocturnal occlusal splint therapy will undergo three 24-hour EMG recordings: at baseline (before splint use), two weeks after splint delivery, and two months after initiation of treatment. During each recording period, participants will also self-report facial pain intensity and awareness of parafunctional activities at regular intervals during wakefulness. EMG outcomes will include average signal amplitude, muscle activation time, and the presence of abnormal co-contraction patterns. These data will be used to assess changes in muscle activity over time and in relation to splint use.

A control group of age- and sex-matched adults without TMD will undergo two 24-hour EMG recordings, two months apart, following the same recording and self-report procedures. Comparisons between the TMD group and controls will allow identification of functional differences in masticatory muscle activity. The primary endpoint is the comparison of masseter muscle EMG activity between participants with TMD and healthy controls, while secondary endpoints include analysis of muscle activation duration and correlations between EMG patterns and reported symptoms. This integrated approach aims to improve understanding of the functional impact of occlusal splints and support more objective diagnosis and management of bruxism and TMD.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Roma
      • Roma, Roma, Italy, 00168
        • Recruiting
        • Clinica Odontostomatologica - Fondazione Policlinico IRCSS A. Gemelli
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm (gnathological occlusal splint)

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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bruxism Personal Index (BPI) as Assessed by 24-Hour Electromyography (EMG) in TMD patients
Time Frame: Baseline (before splint use), 2 weeks after splint delivery, and 2 months after initiation of treatment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

January 10, 2027

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7906

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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