Electromyographic Assessment of Sleep Bruxism in Patients With Stage III and IV Periodontitis
NCT ID: NCT07053865
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2025-06-27
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
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).
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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Ongoing orthodontic treatment
* Temporomandibular disorders (TMD) or orofacial pain
* Use of medications affecting muscle activity
* Systemic or psychiatric disorders
* Diabetes
28 Years
50 Years
ALL
No
Sponsors
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University of Siena
OTHER
Responsible Party
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Nicola Discepoli
Associate Professor
Principal Investigators
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Nicola Discepoli, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Medical Biotechnologies, University of Siena
Locations
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AOUS
Siena, , Italy
Countries
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Other Identifiers
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PB001
Identifier Type: -
Identifier Source: org_study_id
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