Clinical trial NCT06372769: Myoelectric Activity and Mandibular Movement for the Diagnosis of Temporomandibular Disorder
Official title: Comparative Analysis of Myoelectric Activity and Mandibular Movement in Healthy and Temporomandibular Disorder Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Disorder
Keywords: Temporomandibular joint disorder;
Surface electromyography;
Mandibular kinematics;
Sex difference;
Diagnosis.
Lead sponsor: Stomatological Hospital Affiliated with Fujian Medical University
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Surface electromyography (μV)
timeFrame: 3 days
Secondary outcomes:
measure: Mandibular kinematics (mm, mm/s)
timeFrame: 3 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The Affiliated Stomatological Hospital of Fujian Medical University
state: Fujian
Study officials:
References: