Electromyographic Assessment of Sleep Bruxism in Patients With Stage III and IV Periodontitis

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

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Key information

Conditions

Bruxism Behavior Habits Mental Disorders Mouth Diseases Nervous System Diseases Parasomnias Periodontal Diseases Periodontitis Sleep Bruxism Sleep Wake Disorders Stomatognathic Diseases Tooth Diseases

Age range

28 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AOUS

Siena, 53100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Use of removable dentures
Ongoing orthodontic treatment
Temporomandibular disorders (TMD) or orofacial pain
Use of medications affecting muscle activity
Systemic or psychiatric disorders
Diabetes

Treatment and study plan

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).

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Registry information

Official study title

Electromyographic Assessment of Sleep Bruxism in Patients With Stage III and IV Periodontitis: Findings From a Cross-sectional Study.

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jul 8, 2025
Registry last updated: Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed