Clinical Trials Directory

Trials / Completed

CompletedNCT07053865

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
University of Siena · Academic / Other
Sex
All
Age
28 Years – 50 Years
Healthy volunteers
Not accepted

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

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

Interventions

TypeNameDescription
DEVICESurface 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).

Timeline

Start date
2025-06-27
Primary completion
2025-07-31
Completion
2025-07-31
First posted
2025-07-08
Last updated
2025-09-04

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT07053865. Inclusion in this directory is not an endorsement.