Clinical trial Recruiting at 1 site Observational Ages 18 to 79

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 typeObservational
Ages18 Years to 79 Years
SexAll
Enrollment42 (estimated)
SponsorCatholic University of the Sacred Heart
Academic / other
Locations1 site (Roma)
StatusRecruiting
StartedJanuary 16, 2026
Main results expectedJune 30, 2027
Study endsSeptember 30, 2027
Registry record updatedOctober 15, 2026
Trial IDNCT07875738 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

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.