Analysis of Clinical Data of Patients With Temporomandibular Joint Disorder

March 10, 2023 updated by: Meiqing Wang, Air Force Military Medical University, China
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.

Study Overview

Status

Recruiting

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

  1. 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.
  2. 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.
  3. 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

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Shanxi
      • Xi'an, Shanxi, China, 710000
        • Recruiting
        • Forth Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Advertisements were issued in universities and stomatological hospitals to recruit healthy volunteers and patients with temporomandibular joint.

Description

Experimental group

Inclusion Criteria:

No symptoms and signs of oral and maxillofacial dysfunction.

Exclusion Criteria:

  1. Those who have received orthodontic treatment
  2. Have a history of maxillofacial trauma
  3. Maternity
  4. Those who take any medicine for a long time
  5. Patients with chronic diseases such as tumors, endocrine diseases, psychosocial diseases and immune diseases.
  6. 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:

  1. Those who have received orthodontics or other treatment
  2. Have a history of maxillofacial trauma
  3. Maternity
  4. Those who take any medicine for a long time
  5. Patients with chronic diseases such as tumors, endocrine diseases, psychosocial diseases and immune diseases.
  6. Other persons who are unable to cooperate with the project by themselves, such as action barriers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy volunteers
No symptoms and signs of oral and maxillofacial dysfunction are required
Patients with temporomandibular joint disorder

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2023

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

March 10, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Temporomandibular Joint Dysfunction Syndrome

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