NCT06372769

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

April 12, 2024

Last Update Submit

April 16, 2024

Conditions

Keywords

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

Outcome Measures

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.

    3 days

Secondary Outcomes (1)

  • Mandibular kinematics (mm, mm/s)

    3 days

Study Arms (2)

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

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.

Healthy young adults with individual normal occlusionTemporomandibular disorder patients with disc displacement

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Stomatological Hospital of Fujian Medical University

Fuzhou, Fujian, 350002, China

Location

Related Publications (1)

  • Xiaojie X, Yiling C, Honglei L, Jiamei P, Xiaoyong W, Hao Y, Hui C. Comparative analysis of myoelectric activity and mandibular movement in healthy and nonpainful articular temporomandibular disorder subjects. Clin Oral Investig. 2024 Oct 21;28(11):605. doi: 10.1007/s00784-024-05957-z.

MeSH Terms

Conditions

Temporomandibular Joint DisordersDisease

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2024

First Posted

April 18, 2024

Study Start

February 1, 2022

Primary Completion

July 15, 2022

Study Completion

February 10, 2023

Last Updated

April 18, 2024

Record last verified: 2024-04

Locations