Temporomandibular DisorderNCT06372769
Myoelectric Activity and Mandibular Movement for the Diagnosis of Temporomandibular Disorder
An observational study of Temporomandibular Disorder, run by Stomatological Hospital Affiliated with Fujian Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- electromyograph and kinesiograph
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 10 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Stomatological Hospital of Fujian Medical University
Fuzhou, Fujian, 350002
About this study
Official title: Comparative Analysis of Myoelectric Activity and Mandibular Movement in Healthy and Temporomandibular Disorder Subjects
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.
- Conditions
- Temporomandibular Disorder
- Being tested
- electromyograph and kinesiograph
- Keywords
- Temporomandibular joint disorder;, Surface electromyography;, Mandibular kinematics;, Sex difference;, Diagnosis.
- Medical subject headings
- Temporomandibular Joint Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electromyograph and kinesiographDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: electromyograph and kinesiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Feb 2022
- Primary completion15 Jul 2022
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stomatological Hospital Affiliated with Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372769
- Sponsor's protocol ID
- 20240304
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39428401
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Myoelectric Activity and Mandibular Movement in Healthy and Temporomandibular Disorder Subjects
- ClinicalTrials.gov ID
- NCT06372769
- Acronym / sponsor ID
- 20240304
- Conditions
- Temporomandibular Disorder
- Keywords
- Temporomandibular joint disorder;, Surface electromyography;, Mandibular kinematics;, Sex difference;, Diagnosis.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Stomatological Hospital Affiliated with Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy young adults with individual normal occlusion | – | Diagnostic Test: electromyograph and kinesiographHealthy 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. |
| Temporomandibular disorder patients with disc displacement | – | Diagnostic Test: electromyograph and kinesiographPatients 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electromyograph and kinesiographThe 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. | Diagnostic test | Healthy young adults with individual normal occlusion, Temporomandibular disorder patients with disc displacement |
Primary outcome
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.
1 secondary outcome
Mandibular kinematics (mm, mm/s)
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Derived from this study: PubMed 39428401Xiaojie 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorder, run by Stomatological Hospital Affiliated with Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface electromyography (μV) (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06372769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.