Myoelectric Activity and Mandibular Movement for the Diagnosis of Temporomandibular Disorder

Temporomandibular Disorder Clinical Trial

Official title:

Comparative Analysis of Myoelectric Activity and Mandibular Movement in Healthy and Temporomandibular Disorder Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06372769
• Other study ID #: 20240304
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: April 2024
• Source: Stomatological Hospital Affiliated with Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 10, 2023
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Diagnostic Test:
• electromyograph 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.

Locations

Country	Name	City	State
China	The Affiliated Stomatological Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Stomatological Hospital Affiliated with Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 days
Secondary	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.	3 days