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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00932594
Other study ID # SYSU-5010
Secondary ID
Status Recruiting
Phase N/A
First received June 29, 2009
Last updated May 19, 2015
Start date January 2006
Est. completion date December 2026

Study information

Verified date May 2015
Source Sun Yat-sen University
Contact zg zhang, Master
Phone 8602083870387
Email drzhangzg@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to look at temporomandibular joint (TMJ) pressure as a guideline to analyze the different treatments for temporomandibular disorder (TMD), and judge the feasibility of the adjust TMJ pressure treatment and to reach a conclusion on the different treatments for different types of TMD, and determine the new serial treatment of temporomandibular disorders.


Description:

Temporomandibular Disorder is a common disease nowadays, but there is no guideline for the treatment of TMD. TMD can be divided into masticating muscles dysfunction; internal derangement; inflammation; osteoarthrosis, this study will classify the internal derangement, inflammation and osteoarthrosis into three types according to the TMJ pressure. Then the patient will receive the adjust pressure treatment according to their TMJ pressure. The first part of the TMD patients will receive psychogenic treatment, medicine, physical treatment, bite plate, occlusion treatment, rebuilding occlusion treatment, orthodontic treatment, et. If the patients do not have a good curative effect, part of them will change the treatment into arthrocentesis, arthroscopic treatment or operation treatment, the other part of patients, according to their TMJ pressure, receiving the associated adjust pressure treatment or adjust pressure treatment only. This study will call on the patients for three years and collect the clinical information, then doing the medical statistics.


Recruitment information / eligibility

Status Recruiting
Enrollment 4
Est. completion date December 2026
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 60 Years
Eligibility Inclusion Criteria:

- Limited Month Opening

- Abnormal of the Month Opening Type

- Paint During the Month Open or Close

- Condylar Position Paint

- Clicking of the Temporomandibular Joint

- Enlargement of the Upper Temporomandibular Joint Gap

- Dislocation of the Temporomandibular Disc

- Bone of the Temporomandibular Joint Changement

- Patient in the Age of 16-60

- Voluntary Patient

Exclusion Criteria:

- Dysimmunity Disease

- Dysfunction of Heart Liver and Kidney Disease

- Patient can not do the Guide Line

- Life-threatening Patient

- Serious Limited Mouth Opening

- Epilepsy

- Tetanus

- Pregnancy or Women in the Pregnancy Period

- Supportive Temporomandibular Disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Adjust the TMJ Pressure to Normal Value
Adjust the TMJ Pressure by the Operation Only Once for Each Patient
Other:
Do not adjust the pressure of TMJ
Do the treatments normally without additional treatment

Locations

Country Name City State
China Guanghua School of Stomatology and Hospital of Stomatology Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary all cause mortality 24 hours No
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