NCT07861906 · Midwestern University
Masticatory Muscle Activity Using a 24-Hour Wearable Device
What this study is about
Patients with chronic masticatory myofascial pain (MFP) often report that stress and parafunctional taken by mouth habits aggravate their pain, consistent with the widespread belief that stress and parafunctional habits lead to increased/sustained jaw muscle activity and subsequent pain.
View original scientific description
Patients with chronic masticatory myofascial pain (MFP) often report that stress and parafunctional oral habits aggravate their pain, consistent with the widespread belief that stress and parafunctional habits lead to increased/sustained jaw muscle activity and subsequent pain. Yet, these assumptions have never been directly tested, given the lack of tools to measure masticatory muscle activity in real-world settings. This protocol describes a prospective, longitudinal, case-control observational study that will enroll 50 patients total (25 with clinician-diagnosed chronic MFP and 25 age- and sex-matched healthy controls) from the university-based dental clinics at Midwestern University, Illinois. Consenting participants will be instructed to complete a baseline biopsychosocial battery assessing self-reported awake and sleep bruxism (using the Oral Behavior Checklist, OBC), anxiety/depression symptoms (using the Patient Health Questionnaire, PHQ-4), perceived stress (using the Perceived Stress Scale, PSS), insomnia symptoms (using the Insomnia Severity Index, ISI) and chronic pain intensity (using the Graded Chronic Pain Scale, GCPS). All participants will be provided a 24-hour electromyograph (EMG) device (dia-BRUXO, Biotech-Novations, Sanremo, Italy) placed on the left masseter, recording jaw muscle activity. Brief ecological momentary assessments will be sent during the 24-hour period, assessing pain intensity, self-reported parafunctional habits, stress and anxiety. The primary aim will be to establish if self-reported awake and sleep bruxism and/or biopsychosocial distress are as-sociated with EMG-recorded masticatory muscle activity. The secondary aim will test if masticatory muscle activity is associated with jaw pain intensity.
Primary outcome measures
Self-reported parafunctional behaviors
Time frame: Baseline, before the 24-hour assessment period
Self-reported parafunctional behaviors will be assessed using the Oral Behavior Checklist (OBC), a validated instrument to evaluate frequency, type, and overall burden of awake and sleep self-reported oral parafunctional behaviors (e.g., tooth clenching, grinding, jaw bracing, and other repetitive jaw activities). Answers will be rated on a 5-point Likert scale (from 0 = "None of the time" to 4 = "4-7 nights/week"), and item scores will be summed to obtain a total score ranging from 0 to 84, with higher scores indicating a greater frequency and overall burden of self-reported oral parafunctional behaviors.
EMG-recorded masticatory muscle activity
Time frame: During the 24-hour assessment period
Objective EMG-recorded masticatory muscle activity will be collected using the dia-BRUXO, a single-recording channel wireless portable electromyograph.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients of record of the dental institutes at Midwestern University, College of Dental Medicine-Illinois
- Receiving a diagnosis of chronic masticatory myofascial pain according to the Diagnostic Criteria for Temporomandibular Disorders after a consult with the orofacial pain specialist
- Reporting painful symptomatology on the day of the monitoring
- Ability to connect to the Internet
- Ability to read and speak English or Italian language
Exclusion criteria
- Patients undergoing orthodontic treatments
- Not on stable medication regimen on the day of the monitoring
- Starting to wear an occlusal appliance on the day of the monitoring
- Changed occlusal appliance within the past 3 months For the healthy control group, Inclusion Criteria are:
- Sex and age-matched otherwise healthy adults (without any pain-related masticatory myofascial pain upon examination)
- Patients of record of the dental institutes at Midwestern University, College of Dental Medicine-Illinois
- Ability to connect to the Internet
- Ability to read and speak English language Exclusion criteria:
- Patients undergoing orthodontic treatments
- Not on stable medication regimen on the day of the monitoring
- Starting to wear an occlusal appliance on the day of the monitoring
- Changed occlusal appliance within the past 3 months
Where
- Downers Grove, Illinois
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Data: ClinicalTrials.gov · synced Oct 6, 2026 · Source of record for eligibility and locations