Recruiting

Masticatory Muscle Activity

Sponsor:

Midwestern University

Code:

NCT07861906

Conditions

Chronic Masticatory Myofascial Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Chronic Masticatory Myofascial Pain

Study ID

NCT07861906

Start date

Jun 1, 2025

Status verified date

Oct, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

For the chronic myofascial pain group, the Inclusion Criteria are:

  • 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
  • Age 18+
  • 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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Chronic masticatory myofascial pain

Adult patients of the dental institutes, with a clinician-confirmed diagnosis of chronic (>3 months) myofascial pain.

Healthy controls

Sex- and age-matched otherwise healthy adults visiting the dental institute for recall visits, without any pain-related TMD or any other orofacial pain complaint

Primary outcome measure

  • Self-reported parafunctional behaviors [ Time Frame: Baseline, before the 24-hour assessment period ]
  • EMG-recorded masticatory muscle activity [ Time Frame: During the 24-hour assessment period ]

Central Contacts and Locations

Central contacts

Locations

Midwestern University

Recruiting

Downers Grove, Illinois, United States, 60515

Contacts

More Information

Sponsor

Midwestern University

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Keywords

  • masticatory myofascial pain
  • temporomandibular disorders
  • ecologic momentary assessment
  • ambulatory EMG activity
  • orofacial pain
  • parafunctional activities
  • clenching

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Midwestern University on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.