BruxismBRUXINCT07611643
Bruxism Therapy of Facial Pain
A study testing Electromyographic analysis of the masseter muscle using the Diabruxo® device (Biotech-Novations, Sanremo, Italy). in people with Bruxism and Bruxism, Sleep-Related, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This prospective, non-profit study aims to better understand how occlusal splints (gnathological splints) affect daytime and nighttime bruxism (teeth grinding) and clenching in adults with chronic myofascial pain of the jaw muscles, a common form of temporomandibular disorder (TMD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Bruxism, Sleep-Related, Sleep Quality
- What is being tested?
- Electromyographic analysis of the masseter muscle using the Diabruxo® device (Biotech-Novations, Sanremo, Italy).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jan 2026to 10 Jan 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who change their pharmacological regimen during the monitoring period, as drug 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
Clinica Odontostomatologica - Fondazione Policlinico IRCSS A. Gemelli
Roma, Roma, 00168
Prof. Patrizia Gallenzi, +39 0630156358, patrizia.gallenzi@unicatt.it
About this study
Official title: Effect of Therapy for Myofascial Facial Pain on Bruxism/Nocturnal Clenching. Prospective, Non-profit Interventional Study Using a Device.
This prospective, non-profit study aims to better understand how occlusal splints (gnathological splints) affect daytime and nighttime bruxism (teeth grinding) and clenching in adults with chronic myofascial pain of the jaw muscles, a common form of temporomandibular disorder (TMD). Bruxism and clenching are repetitive or sustained jaw muscle activities that can contribute to jaw pain and dysfunction, and their accurate diagnosis requires instrumental assessment of muscle activity. In this study, muscle activity will be objectively measured using a portable device (dia-BRUXO®) worn for 24 hours, which records the electrical activity of the chewing muscles during both wakefulness and sleep. Adult patients with TMD who are prescribed a night-time occlusal splint will undergo three 24-hour recordings: before using the splint, two weeks after starting treatment, and two months later. During each recording, participants will also report their facial pain levels and awareness of clenching or grinding during the day. Their results will be compared with those of a matched control group without TMD. The main goal is to compare jaw muscle activity between patients and healthy individuals, while secondary goals include analyzing how long the muscles are active and how these patterns relate to symptoms. By combining objective measurements and patient-reported experiences, this study seeks to clarify how occlusal splints influence muscle activity and symptoms, helping clinicians improve diagnosis and treatment of bruxism and TMD.
Read the detailed description
This prospective, non-profit interventional study is designed to evaluate the effects of a gnathological occlusal splint on masticatory muscle activity in adults with temporomandibular disorders (TMD) and chronic myofascial pain. Bruxism and clenching, occurring during both wakefulness and sleep, are recognized contributors to TMD symptoms and are best assessed through instrumental measurement. For this purpose, the study uses a validated portable device (dia-BRUXO®) capable of recording the electromyographic (EMG) activity of the masseter muscles continuously over a 24-hour period, allowing objective assessment of muscle activity during daily life and sleep.
Participants with TMD who have a clinical indication for nocturnal occlusal splint therapy will undergo three 24-hour EMG recordings: at baseline (before splint use), two weeks after splint delivery, and two months after initiation of treatment. During each recording period, participants will also self-report facial pain intensity and awareness of parafunctional activities at regular intervals during wakefulness. EMG outcomes will include average signal amplitude, muscle activation time, and the presence of abnormal co-contraction patterns. These data will be used to assess changes in muscle activity over time and in relation to splint use.
A control group of age- and sex-matched adults without TMD will undergo two 24-hour EMG recordings, two months apart, following the same recording and self-report procedures. Comparisons between the TMD group and controls will allow identification of functional differences in masticatory muscle activity. The primary endpoint is the comparison of masseter muscle EMG activity between participants with TMD and healthy controls, while secondary endpoints include analysis of muscle activation duration and correlations between EMG patterns and reported symptoms. This integrated approach aims to improve understanding of the functional impact of occlusal splints and support more objective diagnosis and management of bruxism and TMD.
- Conditions
- Bruxism, Bruxism, Sleep-Related, Sleep Quality
- Being tested
- Electromyographic analysis of the masseter muscle using the Diabruxo® device (Biotech-Novations, Sanremo, Italy).
- Medical subject headings
- Bruxism, Sleep Bruxism, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyographic analysis of the masseter muscle using the Diabruxo® device (Biotech-Novations, Sanremo, Italy).Device
Enrolled participants will be adults with chronic myofascial pain of the masticatory muscles who have a clinical indication for nocturnal treatment with a gnathological occlusal splint. Patients who agree to undergo this therapy for their initial diagnosis will be invited to participate in the study. After providing written informed consent, participants will be given the Diabruxo® device and instructed to perform a 24-hour recording. During device use, patients will be asked to record, on five occasions during wakefulness (every three hours), their level of facial pain and any awareness of parafunctional activities. Following the baseline recording, participants will receive the gnathological occlusal splint and will undergo additional 24-hour recordings two weeks after splint delivery and again two months later, for a total of three recordings per participant. During each recording session, the same self-report measures of facial pain and awareness of parafunctions will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm (gnathological occlusal splint) | Experimental | Adult patients with temporomandibular disorders and chronic myofascial pain of the masticatory muscles treated with a night-time gnathological occlusal splint, with assessment of masticatory muscle electromyographic activity using the dia-BRUXO® device at baseline, after 2 weeks, and after 2 months of splint use.
In addition, there is an observational control group consisting of healthy subjects without temporomandibular disorders, included for comparison purposes only and not considered an interventional arm, as no treatment is administered. Receives: Device: Electromyographic analysis of the masseter muscle using the Diabruxo® device (Biotech-Novations, Sanremo, Italy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruxism Personal Index (BPI) as Assessed by 24-Hour Electromyography (EMG) in TMD patients
The BPI index (n) represents the level of masseter muscle activity recorded continuously over a 24-hour period using the validated portable dia-BRUXO® device.
Measured: Baseline (before splint use), 2 weeks after splint delivery, and 2 months after initiation of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start12 Jan 2026
- Primary completion1 Jun 2026
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gallenzi Patrizia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611643
- Sponsor's protocol ID
- 7906
- Acronym
- BRUXI
- Status last verified
- May 2026
- First submitted
- 16 Dec 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Therapy for Myofascial Facial Pain on Bruxism/Nocturnal Clenching. Prospective, Non-profit Interventional Study Using a Device.
- ClinicalTrials.gov ID
- NCT07611643
- Acronym / sponsor ID
- BRUXI / 7906
- Conditions
- Bruxism, Bruxism, Sleep-Related, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 28 May 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.
This prospective, non-profit study aims to better understand how occlusal splints (gnathological splints) affect daytime and nighttime bruxism (teeth grinding) and clenching in adults with chronic myofascial pain of the jaw muscles, a common form of temporomandibular disorder (TMD). Bruxism and clenching are repetitive or sustained jaw muscle activities that can contribute to jaw pain and dysfunction, and their accurate diagnosis requires instrumental assessment of muscle activity. In this study, muscle activity will be objectively measured using a portable device (dia-BRUXO®) worn for 24 hours, which records the electrical activity of the chewing muscles during both wakefulness and sleep. Adult patients with TMD who are prescribed a night-time occlusal splint will undergo three 24-hour recordings: before using the splint, two weeks after starting treatment, and two months later. During each recording, participants will also report their facial pain levels and awareness of clenching or grinding during the day. Their results will be compared with those of a matched control group without TMD. The main goal is to compare jaw muscle activity between patients and healthy individuals, while secondary goals include analyzing how long the muscles are active and how these patterns relate to symptoms. By combining objective measurements and patient-reported experiences, this study seeks to clarify how occlusal splints influence muscle activity and symptoms, helping clinicians improve diagnosis and treatment of bruxism and TMD.
Detailed description
This prospective, non-profit interventional study is designed to evaluate the effects of a gnathological occlusal splint on masticatory muscle activity in adults with temporomandibular disorders (TMD) and chronic myofascial pain. Bruxism and clenching, occurring during both wakefulness and sleep, are recognized contributors to TMD symptoms and are best assessed through instrumental measurement. For this purpose, the study uses a validated portable device (dia-BRUXO®) capable of recording the electromyographic (EMG) activity of the masseter muscles continuously over a 24-hour period, allowing objective assessment of muscle activity during daily life and sleep.
Participants with TMD who have a clinical indication for nocturnal occlusal splint therapy will undergo three 24-hour EMG recordings: at baseline (before splint use), two weeks after splint delivery, and two months after initiation of treatment. During each recording period, participants will also self-report facial pain intensity and awareness of parafunctional activities at regular intervals during wakefulness. EMG outcomes will include average signal amplitude, muscle activation time, and the presence of abnormal co-contraction patterns. These data will be used to assess changes in muscle activity over time and in relation to splint use.
A control group of age- and sex-matched adults without TMD will undergo two 24-hour EMG recordings, two months apart, following the same recording and self-report procedures. Comparisons between the TMD group and controls will allow identification of functional differences in masticatory muscle activity. The primary endpoint is the comparison of masseter muscle EMG activity between participants with TMD and healthy controls, while secondary endpoints include analysis of muscle activation duration and correlations between EMG patterns and reported symptoms. This integrated approach aims to improve understanding of the functional impact of occlusal splints and support more objective diagnosis and management of bruxism and TMD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm (gnathological occlusal splint) | Experimental | Device: Electromyographic analysis of the masseter muscle using the Diabruxo® device (Biotech-Novations, Sanremo, Italy).Adult patients with temporomandibular disorders and chronic myofascial pain of the masticatory muscles treated with a night-time gnathological occlusal splint, with assessment of masticatory muscle electromyographic activity using the dia-BRUXO® device at baseline, after 2 weeks, and after 2 months of splint use. In addition, there is an observational control group consisting of healthy subjects without temporomandibular disorders, included for comparison purposes only and not considered an interventional arm, as no treatment is administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who change their pharmacological regimen during the monitoring period, as drug 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromyographic analysis of the masseter muscle using the Diabruxo® device (Biotech-Novations, Sanremo, Italy).Enrolled participants will be adults with chronic myofascial pain of the masticatory muscles who have a clinical indication for nocturnal treatment with a gnathological occlusal splint. Patients who agree to undergo this therapy for their initial diagnosis will be invited to participate in the study. After providing written informed consent, participants will be given the Diabruxo® device and instructed to perform a 24-hour recording. During device use, patients will be asked to record, on five occasions during wakefulness (every three hours), their level of facial pain and any awareness of parafunctional activities. Following the baseline recording, participants will receive the gnathological occlusal splint and will undergo additional 24-hour recordings two weeks after splint delivery and again two months later, for a total of three recordings per participant. During each recording session, the same self-report measures of facial pain and awareness of parafunctions will be collected. | Device | Intervention arm (gnathological occlusal splint) |
Primary outcome
Bruxism Personal Index (BPI) as Assessed by 24-Hour Electromyography (EMG) in TMD patients
Time frame: Baseline (before splint use), 2 weeks after splint delivery, and 2 months after initiation of treatment.
The BPI index (n) represents the level of masseter muscle activity recorded continuously over a 24-hour period using the validated portable dia-BRUXO® device.
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 17 Jun 2026.
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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.
Clinica Odontostomatologica - Fondazione Policlinico IRCSS A. Gemelli
Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyographic analysis of the masseter muscle using the Diabruxo® device (Biotech-Novations, Sanremo, Italy). in people with Bruxism and Bruxism, Sleep-Related, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 17 Jun 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bruxism Personal Index (BPI) as Assessed by 24-Hour Electromyography (EMG) in TMD patients (time frame: Baseline (before splint use), 2 weeks after splint delivery, and 2 months after initiation of treatment.). 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 17 Jun 2026.