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

NCT07053865 | Completed

• 1 other identifier: PB001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Bruxism; Periodontitis; Sleep Bruxism

Outcome Measures

Primary Outcomes (1)

• 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

  Within 24 hours after EMG device application

Study Arms (2)

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.

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.

Device: Surface Electromyography (dia-BRUXO)

Interventions

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).

Healthy Control Group; Periodontitis Group

Eligibility Criteria

• Age: 28 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

AOUS

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Bruxism; Periodontitis; Sleep Bruxism

Interventions

Electromyography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Officials

• Nicola Discepoli, DDS, PhD

  Department of Medical Biotechnologies, University of Siena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: June 27, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-09

Locations

IT (1)