Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07611643

Effect of Therapy for Myofascial Facial Pain on Bruxism and Nocturnal Clenching Using a Portable Device

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-05-28

42

Participants Needed

1

Research Sites

31 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating how occlusal splints, also known as gnathological splints, affect daytime and nighttime teeth grinding and clenching in adults with chronic jaw muscle pain caused by temporomandibular disorders (TMD). Bruxism and clenching are repeated or sustained jaw muscle activities that can worsen jaw pain and problems, and this study uses objective measurements to better understand these effects. The study compares adults with TMD who use a night-time occlusal splint to healthy adults without TMD. Participants with TMD will use a portable device called dia-BRUXOae to record muscle activity in the jaw muscles for 24 hours at three points: before starting splint treatment, two weeks after, and two months after. Along with the device recordings, participants will report their facial pain levels and awareness of clenching or grinding during the day. A control group of healthy adults will have two 24-hour muscle activity recordings two months apart for comparison. During the study, participants will wear the device and complete self-reports on their pain and jaw muscle activity at regular intervals. Researchers will measure muscle electrical activity, activation time, and patterns to compare between TMD patients and healthy individuals. The main measure is the Bruxism Personal Index (BPI) from the 24-hour recordings, with assessments at baseline, two weeks, and two months. This study aims to improve diagnosis and treatment of bruxism and TMD by combining objective data with patient experiences.

CONDITIONS

Brief Title

Bruxism Therapy of Facial Pain

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult subjects aged 65 18 years
  • Subjects willing to provide written informed consent
  • Patients with temporomandibular disorders who have an indication for treatment with a gnathological occlusal splint
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 2 months

Participants with temporomandibular disorders use a gnathological occlusal splint at night. Muscle activity is measured with a portable device during daily life and sleep.

3 assessments including 24-hour electromyographic recordings: at baseline before splint use, 2 weeks after splint delivery, and 2 months after starting treatment. Participants self-report facial pain and parafunctional awareness during each recording.

Trial Site Locations

Total: 1 location

1

Clinica Odontostomatologica - Fondazione Policlinico IRCSS A. Gemelli

Roma, Roma, Italy, 00168

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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