Temporomandibular Joint Dysfunction SyndromeNCT05780827
Analysis of Clinical Data of Patients With Temporomandibular Joint Disorder
An observational study of Temporomandibular Joint Dysfunction Syndrome, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
According to our previous research and clinical observation results, the motor function of the oral, maxillofacial and cervical body is closely related to the occlusal contact. Not only that, the occlusal contact also affects the psychological activities related to movement. Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2023to 30 Jun 2024
- 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 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Advertisements were issued in universities and stomatological hospitals to recruit healthy volunteers and patients with temporomandibular joint.
Who may be able to join
- No symptoms and signs of oral and maxillofacial dysfunction.
- Suffer from symptoms and signs of oral and maxillofacial dysfunction
Who cannot join
- Those who have received orthodontic treatment
- Have a history of maxillofacial trauma
- Maternity
- Those who take any medicine for a long time
- Patients with chronic diseases such as tumors, endocrine diseases, psychosocial diseases and immune diseases.
- Other persons who are unable to cooperate with the project by themselves, such as action barriers.
Show all 13Show fewer
- Control group
- Those who have received orthodontics or other treatment
- Have a history of maxillofacial trauma
- Maternity
- Those who take any medicine for a long time
- Patients with chronic diseases such as tumors, endocrine diseases, psychosocial diseases and immune diseases.
- Other persons who are unable to cooperate with the project by themselves, such as action barriers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Forth Military Medical University
Xi’an, Shanxi, 710000
Zebin Li, Master, 18928897226, 450444636@qq.com
About this study
According to our previous research and clinical observation results, the motor function of the oral, maxillofacial and cervical body is closely related to the occlusal contact. Not only that, the occlusal contact also affects the psychological activities related to movement. There are many technical means to evaluate the occlusion clinically. However, the occlusion is a complex motor organ with more than 3 dimensional (including age factors) morphological characteristics, which makes the occlusion have obvious individualized characteristics. It is of great significance to objectively evaluate oral health to accurately extract occlusal contact features, analyze the relationship between occlusion and the motor function of oral, maxillofacial, neck and body as well as the corresponding psychological characteristics, and establish an evaluation method of occlusal function for evaluating motor function and psychological characteristics.
Read the detailed description
The project is intended to carry out the correlation between occlusal contact and subclinical indicators of physical and mental health. The data collection method combining occlusal detection, physical fitness detection and questionnaire survey is adopted to obtain the target data, and then the machine learning method is used to extract the sensitive technical parameters from the collected data.
- Data collection
- 3D occlusal contact detection: It is planned to recruit 1000 healthy volunteers and use "oral laser scanner" to conduct 3D scanning on them, so as to obtain 3D occlusal digital model data of 1000 healthy volunteers. A control group was set up at the same time, and the model and data of 10000 patients who had previously visited the hospital in our department's existing case database were used for comparative analysis.
- Physical fitness test: for the dynamic/static standing balance function test of volunteers, the dynamic/static balance test system developed by our research group is used to test and obtain physical fitness parameters. The sample size is statistically estimated, and the average number of dynamic/static tests is not less than 50. A control group was established at the same time: volunteers with temporomandibular joint disorder and abnormal occlusion.
- Psychological evaluation: including volunteers' personality characteristics, mental health level and basic flight ability.
- The extraction of machine learning occlusal parameters uses the 3D occlusal evaluation system reported by us to calculate the occlusal tightness, and extracts the three-dimensional direction and comprehensive parameters of the upper and lower jaw according to the method reported by us, a total of 10 quantitative indicators.
- Correlation analysis of occlusal contact and physical and mental health indicators For the collected occlusal parameter data, the physical parameter data obtained from the dynamic/static orthostatic balance function test, and the psychological parameter data obtained from the personality characteristics, mental health level and other tests, the difference of the dynamic/static ability of volunteers with healthy, temporomandibular joint disorder and abnormal occlusion was compared with the analysis of variance; Multiple regression method was used for correlation test; Machine learning is used for cluster analysis.
- Keywords
- Postural Balance, Occlusion
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | No symptoms and signs of oral and maxillofacial dysfunction are required | |
| Patients with temporomandibular joint disorder | Patients with temporomandibular joint disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Balance
Use the "balance tester" to measure the dynamic and static measurement data of "healthy volunteers" and "patients with TMD", and carry out the homogeneity test of variance for the obtained measurement data. If it is subject to the homogeneity of variance, carry out the group t-test or analysis of variance for the data, and compare the differences between groups and within groups.
Measured: 2023.02.16-2023.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start21 Feb 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Dysfunction SyndromeStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meiqing Wang, Air Force Military Medical University, China
- Investigators
- Wang MeiQing, M.D, Study director, Professor, State Key Laboratory of Military Stomatology, Department of Oral Anatomy and Physiology, School of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780827
- Sponsor's protocol ID
- Oral Anatomy & Physiology AFMU
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical Data of Patients With Temporomandibular Joint Disorder
- ClinicalTrials.gov ID
- NCT05780827
- Acronym / sponsor ID
- Oral Anatomy & Physiology AFMU
- Keywords
- Postural Balance, Occlusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 23 Mar 2023 (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.
According to our previous research and clinical observation results, the motor function of the oral, maxillofacial and cervical body is closely related to the occlusal contact. Not only that, the occlusal contact also affects the psychological activities related to movement. There are many technical means to evaluate the occlusion clinically. However, the occlusion is a complex motor organ with more than 3 dimensional (including age factors) morphological characteristics, which makes the occlusion have obvious individualized characteristics. It is of great significance to objectively evaluate oral health to accurately extract occlusal contact features, analyze the relationship between occlusion and the motor function of oral, maxillofacial, neck and body as well as the corresponding psychological characteristics, and establish an evaluation method of occlusal function for evaluating motor function and psychological characteristics.
Detailed description
The project is intended to carry out the correlation between occlusal contact and subclinical indicators of physical and mental health. The data collection method combining occlusal detection, physical fitness detection and questionnaire survey is adopted to obtain the target data, and then the machine learning method is used to extract the sensitive technical parameters from the collected data.
- Data collection
- 3D occlusal contact detection: It is planned to recruit 1000 healthy volunteers and use "oral laser scanner" to conduct 3D scanning on them, so as to obtain 3D occlusal digital model data of 1000 healthy volunteers. A control group was set up at the same time, and the model and data of 10000 patients who had previously visited the hospital in our department's existing case database were used for comparative analysis.
- Physical fitness test: for the dynamic/static standing balance function test of volunteers, the dynamic/static balance test system developed by our research group is used to test and obtain physical fitness parameters. The sample size is statistically estimated, and the average number of dynamic/static tests is not less than 50. A control group was established at the same time: volunteers with temporomandibular joint disorder and abnormal occlusion.
- Psychological evaluation: including volunteers' personality characteristics, mental health level and basic flight ability.
- The extraction of machine learning occlusal parameters uses the 3D occlusal evaluation system reported by us to calculate the occlusal tightness, and extracts the three-dimensional direction and comprehensive parameters of the upper and lower jaw according to the method reported by us, a total of 10 quantitative indicators.
- Correlation analysis of occlusal contact and physical and mental health indicators For the collected occlusal parameter data, the physical parameter data obtained from the dynamic/static orthostatic balance function test, and the psychological parameter data obtained from the personality characteristics, mental health level and other tests, the difference of the dynamic/static ability of volunteers with healthy, temporomandibular joint disorder and abnormal occlusion was compared with the analysis of variance; Multiple regression method was used for correlation test; Machine learning is used for cluster analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | –No symptoms and signs of oral and maxillofacial dysfunction are required |
| Patients with temporomandibular joint disorder | – | –Patients with temporomandibular joint disorder |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Advertisements were issued in universities and stomatological hospitals to recruit healthy volunteers and patients with temporomandibular joint.
Key inclusion criteria (2 listed)
- No symptoms and signs of oral and maxillofacial dysfunction.
- Suffer from symptoms and signs of oral and maxillofacial dysfunction
Key exclusion criteria (13 listed)
- Those who have received orthodontic treatment
- Have a history of maxillofacial trauma
- Maternity
- Those who take any medicine for a long time
- Patients with chronic diseases such as tumors, endocrine diseases, psychosocial diseases and immune diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postural Balance
Time frame: 2023.02.16-2023.12.31
Use the "balance tester" to measure the dynamic and static measurement data of "healthy volunteers" and "patients with TMD", and carry out the homogeneity test of variance for the obtained measurement data. If it is subject to the homogeneity of variance, carry out the group t-test or analysis of variance for the data, and compare the differences between groups and within groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Temporomandibular Joint Dysfunction Syndrome
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Not yet recruitingObservational study
Comparison of Cervical and TMJ Parameters in Young Adults With and Without Text Neck Syndrome
Text Neck Syndrome, Temporomandibular Joint Disorders
Recruiting
Temporomandibular Joint (TMJ) Positioning Accuracy and Efficiency Using a Dental Compass.
Temporomandibular Joint Syndrome
Not yet recruiting
Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders
Temporomandibular Disorders (TMDs), Myofascial Pain - Dysfunction Syndrome of TMJ
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.
Wang MeiQing, M.D study director
Professor, State Key Laboratory of Military Stomatology, Department of Oral Anatomy and Physiology, School of Stomatology
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 Joint Dysfunction Syndrome, run by Air Force Military Medical University, China 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 13 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: status not confirmed, as of the sponsor's last update on 23 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact li Zebin, Master (8618928897226, 450444636@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Balance (time frame: 2023.02.16-2023.12.31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2023.