BruxismNCT07053865
Electromyographic Assessment of Sleep Bruxism in Patients With Stage III and IV Periodontitis
An observational study of Bruxism and Periodontitis, run by University of Siena at 1 site in Italy.
Trial summary
This study aims to investigate the association between periodontitis Stage III and IV and the intensity and duration of sleep bruxism episodes. Surface electromyography (EMG) of the masseter muscle will be used to instrumentally assess sleep bruxism in patients with and without periodontal disease Read more about this study
- Who is it for?
- Ages 28 to 50 years
- Conditions the study is for
- Bruxism, Periodontitis, Sleep Bruxism
- What is being tested?
- Surface Electromyography (dia-BRUXO)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jun 2025to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 28 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients and healthy controls aged 28-50 years recruited at the University of Siena, Italy. The study includes both individuals with advanced periodontitis and healthy controls.
Who may be able to join
- Age between 28 and 50 years
- Ability to perform adequate oral hygiene
- Willingness to participate and sign informed consent
- For periodontitis group: Diagnosis of Stage III or IV periodontitis
- For control group: Absence of periodontal disease
Who cannot join
- Use of removable dentures
- Ongoing orthodontic treatment
- Temporomandibular disorders (TMD) or orofacial pain
- Use of medications affecting muscle activity
- Systemic or psychiatric disorders
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electromyographic Assessment of Sleep Bruxism in Patients With Stage III and IV Periodontitis: Findings From a Cross-sectional Study.
This study aims to investigate the association between periodontitis Stage III and IV and the intensity and duration of sleep bruxism episodes. Surface electromyography (EMG) of the masseter muscle will be used to instrumentally assess sleep bruxism in patients with and without periodontal disease
Read the detailed description
The purpose of this cross-sectional study is to evaluate whether patients with Stage III and IV periodontitis exhibit differences in sleep bruxism activity compared to individuals without periodontal disease. Participants will undergo comprehensive periodontal assessment and 24-hour EMG recording of the masseter muscle using a portable device. Bruxism activity will be quantified using the Bruxism Work Index (BWI) and Bruxism Time Index (BTI). The study aims to clarify the potential relationship between periodontal inflammation and masticatory muscle activity during sleep, following standardized diagnostic and recording protocols
- Conditions
- Bruxism, Periodontitis, Sleep Bruxism
- Being tested
- Surface Electromyography (dia-BRUXO)
- Medical subject headings
- Bruxism, Periodontitis, Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface Electromyography (dia-BRUXO)Device
Participants will undergo 24-hour surface electromyographic recording of the left masseter muscle using the dia-BRUXO portable device to quantify sleep bruxism activity through Bruxism Work Index (BWI) and Bruxism Time Index (BTI).
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis Group | Patients diagnosed with Stage III or IV periodontitis according to the 2017 World Workshop classification. Participants will undergo full-mouth periodontal examination and 24-hour surface EMG recording of the masseter muscle to assess sleep bruxism activity. Receives: Device: Surface Electromyography (dia-BRUXO) | |
| Healthy Control Group | Participants without clinical signs of periodontal disease, matched by age and sex to the periodontitis group. They will also receive a full-mouth periodontal screening and 24-hour surface EMG recording of the masseter muscle for sleep bruxism assessment. Receives: Device: Surface Electromyography (dia-BRUXO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Bruxism Work Index (BWI)
BWI is calculated as the percentage of muscle work exerted during bruxism-related masticatory activity relative to the theoretical maximum work. It will be used to assess the intensity of sleep bruxism based on EMG recordings of the masseter muscle
Measured: Within 24 hours after EMG device application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start27 Jun 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
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.
- 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
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Discepoli, University of Siena
- Investigators
- Nicola Discepoli, DDS, PhD, Principal investigator, Department of Medical Biotechnologies, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053865
- Sponsor's protocol ID
- PB001
- Status last verified
- Sep 2025
- First submitted
- 27 Jun 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic Assessment of Sleep Bruxism in Patients With Stage III and IV Periodontitis: Findings From a Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT07053865
- Acronym / sponsor ID
- PB001
- Conditions
- Bruxism, Periodontitis, Sleep Bruxism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 8 Jul 2025 (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 study aims to investigate the association between periodontitis Stage III and IV and the intensity and duration of sleep bruxism episodes. Surface electromyography (EMG) of the masseter muscle will be used to instrumentally assess sleep bruxism in patients with and without periodontal disease
Detailed description
The purpose of this cross-sectional study is to evaluate whether patients with Stage III and IV periodontitis exhibit differences in sleep bruxism activity compared to individuals without periodontal disease. Participants will undergo comprehensive periodontal assessment and 24-hour EMG recording of the masseter muscle using a portable device. Bruxism activity will be quantified using the Bruxism Work Index (BWI) and Bruxism Time Index (BTI). The study aims to clarify the potential relationship between periodontal inflammation and masticatory muscle activity during sleep, following standardized diagnostic and recording protocols
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis Group | – | Device: Surface Electromyography (dia-BRUXO)Patients diagnosed with Stage III or IV periodontitis according to the 2017 World Workshop classification. Participants will undergo full-mouth periodontal examination and 24-hour surface EMG recording of the masseter muscle to assess sleep bruxism activity. |
| Healthy Control Group | – | Device: Surface Electromyography (dia-BRUXO)Participants without clinical signs of periodontal disease, matched by age and sex to the periodontitis group. They will also receive a full-mouth periodontal screening and 24-hour surface EMG recording of the masseter muscle for sleep bruxism assessment. |
Who may qualify
- Ages
- 28 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients and healthy controls aged 28-50 years recruited at the University of Siena, Italy. The study includes both individuals with advanced periodontitis and healthy controls.
Key inclusion criteria (5 listed)
- Age between 28 and 50 years
- Ability to perform adequate oral hygiene
- Willingness to participate and sign informed consent
- For periodontitis group: Diagnosis of Stage III or IV periodontitis
- For control group: Absence of periodontal disease
Key exclusion criteria (6 listed)
- Use of removable dentures
- Ongoing orthodontic treatment
- Temporomandibular disorders (TMD) or orofacial pain
- Use of medications affecting muscle activity
- Systemic or psychiatric disorders
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 |
|---|---|---|
| Surface Electromyography (dia-BRUXO)Participants will undergo 24-hour surface electromyographic recording of the left masseter muscle using the dia-BRUXO portable device to quantify sleep bruxism activity through Bruxism Work Index (BWI) and Bruxism Time Index (BTI). | Device | Healthy Control Group, Periodontitis Group |
Primary outcome
Sleep Bruxism Work Index (BWI)
Time frame: Within 24 hours after EMG device application
BWI is calculated as the percentage of muscle work exerted during bruxism-related masticatory activity relative to the theoretical maximum work. It will be used to assess the intensity of sleep bruxism based on EMG recordings of the masseter muscle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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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. This study is not recruiting at the moment.
Nicola Discepoli, DDS, PhD principal investigator
Department of Medical Biotechnologies, University of Siena
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 Bruxism and Periodontitis, run by University of Siena 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 4 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Bruxism Work Index (BWI) (time frame: Within 24 hours after EMG device application). 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 4 Sep 2025.