- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06372769
Myoelectric Activity and Mandibular Movement for the Diagnosis of Temporomandibular Disorder
Comparative Analysis of Myoelectric Activity and Mandibular Movement in Healthy and Temporomandibular Disorder Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Fujian
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Fuzhou, Fujian, China, 350002
- The Affiliated Stomatological Hospital of Fujian Medical University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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. |
|
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surface electromyography (μV)
Time Frame: 3 days
|
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.
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3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mandibular kinematics (mm, mm/s)
Time Frame: 3 days
|
Kinesiographic recordings were performed using a kinesiograph, the maximum mouth Maximal opening, maximal and average opening and closing velocities were measured.
|
3 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20240304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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