Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Bruxism Therapy with a Splint for Facial Pain

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

Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07611643 · Data updated 2026-11-12

This study tests whether wearing a night-time occlusal splint changes jaw muscle activity in adults with temporomandibular disorders and chronic jaw pain, using a portable EMG device to track activity over 24 hours.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment42 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Locations1 site (Roma, Roma)
StatusRecruiting
StartedJanuary 12, 2026
Main results expectedJune 1, 2026
Study endsJanuary 10, 2027
Registry record updatedJune 17, 2026
Trial IDNCT07611643 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) with temporomandibular disorders who have a clinical indication for gnathological occlusal splint therapy.

Probably not a fit

Patients without TMD or without an indication for a nocturnal splint may not experience benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, interventional study uses a gnathological occlusal splint to see if it alters masseter muscle activity in adults with TMD and chronic myofascial jaw pain. Muscle activity will be measured with the dia-BRUXO device over three 24-hour periods: before splint use, two weeks after starting the splint, and two months after. A parallel control group of age- and sex-matched adults without TMD will complete two 24-hour recordings. Outcomes include EMG metrics such as mean amplitude, activation time, and co-contraction patterns, along with self-reported facial pain and awareness of parafunctional activity. The goal is to understand how splint therapy influences real-world jaw muscle activity and symptom experience.

Why it matters

Potential benefit: If successful, the splint could reduce abnormal jaw muscle activity and related pain for people with TMD.

How similar studies have gone: Previous work has shown that occlusal splints can affect muscle activity in TMD, but this study adds objective, real-life EMG data and a parallel control group.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.