Masticatory Myofascial PainNCT07875738
Effect Of Orofacial Pain Therapy On Bruxism
An observational study of Masticatory Myofascial Pain, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Bruxism and clenching at night and during the day are considered the most common parafunctions that can influence temporomandibular disorders, including chronic myofascial pain of the masticatory muscles. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Masticatory Myofascial Pain
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jan 2026to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adults patients with chronic masticatory myofascial pain
Who may be able to join
- Adult subjects
- Subjects who agree to sign the informed consent form
- Patients with temporomandibular dysfunction who are indicated for treatment with a gnathological splint
Who cannot join
- Patients who change their medication regimen during the monitoring period because pharmacological therapy may affect facial pain and/or muscle activity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Università Cattolica del Sacro Cuore
Roma, 00168
Università Cattolica del Sacro cuore, +393341413280, anna.alessandribonetti@unicatt.it
About this study
Official title: Effetto Della Terapia Per Il Dolore Facciale Miofasciale Sul Bruxismo/Serramento
Bruxism and clenching at night and during the day are considered the most common parafunctions that can influence temporomandibular disorders, including chronic myofascial pain of the masticatory muscles. When bruxism and/or clenching are present, treatment generally includes the use of a gnathological splint at night. According to the International Consensus on Bruxism, a definitive diagnosis of bruxism/clenching requires an instrumental assessment consisting of an electromyographic recording of masticatory muscle activity. In this regard, over the past four years, an Italian company (Biotech-Novations, Sanremo, Italy) has created a portable device (dia- BRUXO) to be worn for 24 hours (day and night) that measures muscle activity in the oral region. The company has established baseline cut-off values for daytime and nighttime muscle activity. The aim of the study is to investigate the effectiveness of using gnathological splints in reducing bruxism and clenching during wakefulness and sleep in adults with chronic myofascial pain.
- Conditions
- Masticatory Myofascial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic masticatory myofascial pain | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of gnathological splints on bruxism during wakefulness and sleep in adults with myofascial pain, measured through EMG values obtained by dia-BRUXO device. During treatment EMG values will be compared for each subject to pre-treatment EMG
EMG-recorded masticatory muscle activity will be collected using the dia-BRUXO device; which is a tool to diagnose bruxism and clenching both during wakefulness and sleep. patients with chronic myfascial pain will undergo dia-BRUXO registration at baseline and 2 months after receiving a gnathological splint (the regular treatment for bruxism) for night time use. changes will be compared between pre and during treatment. a control group of subjects without pain will undergo the same registrations at 2 months distance, without splint use.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start16 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Masticatory Myofascial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Alessandri Bonetti, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875738
- Sponsor's protocol ID
- ID7906
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effetto Della Terapia Per Il Dolore Facciale Miofasciale Sul Bruxismo/Serramento
- ClinicalTrials.gov ID
- NCT07875738
- Acronym / sponsor ID
- ID7906
- Conditions
- Masticatory Myofascial Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bruxism and clenching at night and during the day are considered the most common parafunctions that can influence temporomandibular disorders, including chronic myofascial pain of the masticatory muscles. When bruxism and/or clenching are present, treatment generally includes the use of a gnathological splint at night. According to the International Consensus on Bruxism, a definitive diagnosis of bruxism/clenching requires an instrumental assessment consisting of an electromyographic recording of masticatory muscle activity. In this regard, over the past four years, an Italian company (Biotech-Novations, Sanremo, Italy) has created a portable device (dia- BRUXO) to be worn for 24 hours (day and night) that measures muscle activity in the oral region. The company has established baseline cut-off values for daytime and nighttime muscle activity. The aim of the study is to investigate the effectiveness of using gnathological splints in reducing bruxism and clenching during wakefulness and sleep in adults with chronic myofascial pain.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic masticatory myofascial pain | – | – |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adults patients with chronic masticatory myofascial pain
Key inclusion criteria (3 listed)
- Adult subjects
- Subjects who agree to sign the informed consent form
- Patients with temporomandibular dysfunction who are indicated for treatment with a gnathological splint
Key exclusion criteria (1 listed)
- Patients who change their medication regimen during the monitoring period because pharmacological therapy may affect facial pain and/or muscle activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
effectiveness of gnathological splints on bruxism during wakefulness and sleep in adults with myofascial pain, measured through EMG values obtained by dia-BRUXO device. During treatment EMG values will be compared for each subject to pre-treatment EMG
Time frame: 24 months
EMG-recorded masticatory muscle activity will be collected using the dia-BRUXO device; which is a tool to diagnose bruxism and clenching both during wakefulness and sleep. patients with chronic myfascial pain will undergo dia-BRUXO registration at baseline and 2 months after receiving a gnathological splint (the regular treatment for bruxism) for night time use. changes will be compared between pre and during treatment. a control group of subjects without pain will undergo the same registrations at 2 months distance, without splint use.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Masticatory Myofascial Pain, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Alessandri Bonetti (+393341413280, anna.alessandribonetti@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of gnathological splints on bruxism during wakefulness and sleep in adults with myofascial pain, measured through EMG values obtained by dia-BRUXO device. During treatment EMG values will be compared for each subject to pre-treatment EMG (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.