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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, Roma) |
| Status | Recruiting |
| Started | January 12, 2026 |
| Main results expected | June 1, 2026 |
| Study ends | January 10, 2027 |
| Registry record updated | June 17, 2026 |
| Trial ID | NCT07611643 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.