Masticatory Muscle Activity Using a 24-Hour Wearable Device
Public ClinicalTrials.gov record NCT07861906. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Reevaluating the Role of Masticatory Muscle Activity in Chronic Myofascial Pain Using a 24-Hour Wearable Device
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07861906
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 1, 2025 (Actual)
- Primary completion
- Jul 31, 2027 (Estimated)
- Completion
- Sep 30, 2027 (Estimated)
- Last update posted
- Oct 6, 2026
2025 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Midwestern University | Downers Grove | Illinois | 60515 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07861906, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 6, 2026 · Synced Oct 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07861906 live on ClinicalTrials.gov.