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CompletedNCT06372769Updated Apr 18, 2024

Myoelectric Activity and Mandibular Movement for the Diagnosis of Temporomandibular Disorder

An observational study in Temporomandibular Disorder, sponsored by Stomatological Hospital Affiliated with Fujian Medical University. Completed at 1 site in China. Open to participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-18.

Sponsored by Stomatological Hospital Affiliated with Fujian Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
120
Ages
20 Years to 35 Years
Sex
All
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Study summary

This study aimed to provide normal reference values of surface electromyography (sEMG) and mandibular kinematics in Chinese young adults, compare the sex differences and assess the diagnosis value of these indices.

Read the detailed description

Temporomandibular disorders (TMD) are one of the leading causes of craniofacial pain, and a high incidence of TMD in young adults has been reported. Previous studies have used sEMG and mandibular kinematic analysis to diagnose TMD. This was an observational study that healthy young adults with individual normal occlusion were strictly selected by diagnosis standard, and TMD patients with disc displacement were recruited. The sEMG signals of the anterior temporalis (TA), masseter (MM), and sternocleidomastoid and digastric were recorded in the mandibular postural positions (MPP) and during maximal voluntary clenching (MVC) with K7 electromyograph. Mandibular kinematics, including maximum opening and opening/closing velocities, were assessed by K7 kinesiograph.

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Conditions studied

  • Temporomandibular Disorder

Keywords

  • Temporomandibular joint disorder;
  • Surface electromyography;
  • Mandibular kinematics;
  • Sex difference;
  • Diagnosis.
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In context

Temporomandibular Joint Disorders

609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.

This study's enrollment of 120 is above the median of 90 across 165 observational studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Stomatological Hospital Affiliated with Fujian Medical University is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy volunteers were recruited from college students of Fujian Medical University, while the temporomandibular disorder participants were recruited through public invitations, via recruitment posters and personal contacts.

Inclusion criteria

  • Centred midline and no marked restriction and deviation of mouth opening and closing; ·Overjet and overbite of 1-3 mm, bilateral molar support with molar and cusp relation of Angle's class I;
  • Presence of complete permanent dentition, except third molars.

Exclusion criteria

Exclusion Criteria:

  • History of local or general trauma;
  • Presence of systemic diseases, neurological or psychiatric disorders, muscular diseases, cervical pain, or TMD based on the Research Diagnostic Criteria (RDC);
  • Pregnancy;
  • Consumption of anti-inflammatory, analgesic, antidepressant, or myorelaxant drugs;
  • Presence of parafunctional facets and anamnesis of parafunctional tooth clenching, bruxism, or unilateral chewing;
  • Presence of obvious dentition crowding or spacing, malposed, supernumerary or fractured tooth, visible caries, tooth abrasion/hypersensitivity, toothache, periodontal disease, or occlusal discomfort;
  • Fixed or removable restorations, tooth filling, or occlusal adjustment that affected the occlusal surfaces;
  • Previous or concurrent orthodontic, orthognathic, or TMJ treatment.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy young adults with individual normal occlusion

    Healthy subjects who fulfilled the following criteria: centred midline and no marked restriction and deviation of mouth opening and closing; overjet and overbite of 1-3 mm, bilateral molar support with molar and cusp relation of Angle's class I, and presence of complete permanent dentition, except third molars.

    Diagnostic Test: electromyograph and kinesiograph

  • Temporomandibular disorder patients with disc displacement

    Patients with unilateral or bilateral temporomandibular joint (TMJ) disc displacement symptoms, such as TMJ clicking, TMJ locking, and limitation in opening mouth were included in the study. The study did not cover the patients with muscle disorders (myofascial pain), with arthralgia, osteoarthritis, and osteoarthrosis, with TMJ fracture, with dentofacial deformity, with systemic disease affecting TMJ, and undergone TMD treatments.

    Diagnostic Test: electromyograph and kinesiograph

Interventions

  • Diagnostic testelectromyograph and kinesiograph

    The sEMG of the anterior temporalis (TA), masseter (MM), sternocleidomastoid (cervical group, CG), and digastric (DA) were recorded simultaneously with an sEMG device (K7/EMG, USA) using disposable silver/silver chloride bipolar surface electrodes. First, sEMG was conducted on four pairs of muscles (TA, MM, CG, and DA) in the MPP, and subjects were guided to maintain the face and jaw as relaxed as possible. To determine the relative efficiency of muscle function, the second test was performed to measure the sEMG of TA and MM during the maximal biting force against natural dentition. In the third test, subjects were guided to clench three times to monitor early motor unit recruitment as they closed from rest through freeway space to initial tooth contact. Kinesiographic recordings were performed using a kinesiograph (K7/Computerized Mandibular Scanning (CMS), USA) that measured the maximum mouth opening (MMO) and opening and closing velocities.

06

What researchers measure

Primary outcomes

  1. Surface electromyography (μV)

    The sEMG of the anterior temporalis (TA), masseter (MM), sternocleidomastoid (cervical group, CG), and digastric (DA) during mandibular postural position and maximal clench were recorded.

    Time frame: 3 days

Secondary outcomes

  1. Mandibular kinematics (mm, mm/s)

    Kinesiographic recordings were performed using a kinesiograph, the maximum mouth Maximal opening, maximal and average opening and closing velocities were measured.

    Time frame: 3 days

07

Study locations

1 site
  • The Affiliated Stomatological Hospital of Fujian Medical University
    Fuzhou, Fujian 350002, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06372769
Lead sponsor
Stomatological Hospital Affiliated with Fujian Medical University
Responsible party
Sponsor
First posted
Apr 18, 2024
Start date
Feb 1, 2022
Primary completion
Jul 15, 2022
Completion
Feb 10, 2023
Last update
Apr 18, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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