- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05780827
Analysis of Clinical Data of Patients With Temporomandibular Joint Disorder
Study Overview
Status
Conditions
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.
1. 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.
2. 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.
3. 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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: li Zebin, Master
- Phone Number: 8618928897226
- Email: 450444636@qq.com
Study Locations
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Shanxi
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Xi'an, Shanxi, China, 710000
- Recruiting
- Forth Military Medical University
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Contact:
- Zebin Li, Master
- Phone Number: 18928897226
- Email: 450444636@qq.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Experimental group
Inclusion Criteria:
No symptoms and signs of oral and maxillofacial dysfunction.
Exclusion Criteria:
- 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.
Control group
Inclusion Criteria:
Suffer from symptoms and signs of oral and maxillofacial dysfunction
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Healthy volunteers
No symptoms and signs of oral and maxillofacial dysfunction are required
|
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Patients with temporomandibular joint disorder
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2023.02.16-2023.12.31
|
Collaborators and Investigators
Investigators
- Study Director: Wang MeiQing, M.D, Professor, State Key Laboratory of Military Stomatology, Department of Oral Anatomy and Physiology, School of Stomatology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- Oral Anatomy & Physiology AFMU
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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