Effect of Orofacial Pain Therapy on Bruxism
Official title: Effetto Della Terapia Per Il Dolore Facciale Miofasciale Sul Bruxismo/Serramento
Run by Catholic University of the Sacred Heart · NCT07875738 · Data updated 2026-11-12
This study tests whether gnathological splints can reduce daytime and nighttime bruxism and clenching in adults with masticatory myofascial pain, using a portable 24-hour muscle activity monitor.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 79 Years |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | Catholic University of the Sacred Heart Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | January 16, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT07875738 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with temporomandibular dysfunction who are indicated for gnathological splint therapy and who can consent to participation.
✕Probably not a fit
Patients who do not experience reduced muscle activity or who have confounding changes in medications during the monitoring period may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study assesses how well gnathological splints work to reduce bruxism and clenching in adults with temporomandibular dysfunction and masticatory myofascial pain. Participants will be monitored with a 24-hour portable device that records masticatory muscle activity to establish daytime and nighttime cut-offs. The goal is to see if wearing a splint correlates with decreased muscle activity during wakefulness and sleep. The study is conducted at the Università Cattolica del Sacro Cuore in Rome under the Catholic University of the Sacred Heart, with no listed external collaborators. Eligibility requires informed consent and a clinical indication for splint therapy; changes in medication during monitoring are excluded to avoid confounding effects on pain or muscle activity.
Why it matters
Potential benefit: If successful, splint therapy could reduce bruxism and muscle strain, potentially easing pain and improving jaw function.
How similar studies have gone: Prior approaches using splints for bruxism and myofascial trigeminal pain have shown mixed results, making this observational work exploratory for device-informed monitoring.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Adult subjects * Subjects who agree to sign the informed consent form * Patients with temporomandibular dysfunction who are indicated for treatment with a gnathological splint Exclusion criteria: \- Patients who change their medication regimen during the monitoring period because pharmacological therapy may affect facial pain and/or muscle activity.
Where it's running
-
Università Cattolica del Sacro Cuore
Roma, Italy Recruiting
Study contacts
- Study coordinator: Anna Alessandri Bonetti
- Email: anna.alessandribonetti@unicatt.it
- Phone: +393341413280
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Diffusion MRI to measure jaw muscle changes in masticatory myofascial pain
This study will test whether diffusion MRI can detect differences in the jaw muscles of adults with masticatory myofascial pain syndrome.
-
Masticatory Muscle Activity with a 24-Hour Wearable Device
This study tests whether real-world jaw muscle activity relates to stress and parafunctional habits in people with chronic masticatory myofascial pain compared with healthy controls using a wearable EMG device.
-
Occlusal splint and masseter Botox effects on jaw and neck muscles
We will test whether a custom jaw splint, Botox injections into the masseter muscles, or both, can change head and neck muscle activity in adults with myofascial pain syndrome.
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.