The New Serial Treatment of Temporomandibular Disorders

NCT ID: NCT00932594

Last Updated: 2015-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Temporomandibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1.Arthrocentesis only

Patients only have Arthrocentesis, but without adjusting the pressure of the TMJ

Group Type ACTIVE_COMPARATOR

Do not adjust the pressure of TMJ

Intervention Type OTHER

Do the treatments normally without additional treatment

3.Arthroscopic Treatment

Patient receives Arthroscopic treatments without adjusting the TMJ pressure

Group Type ACTIVE_COMPARATOR

Do not adjust the pressure of TMJ

Intervention Type OTHER

Do the treatments normally without additional treatment

4.Arthroscopic with Adjust Pressure

Arthroscopic Treatment with Adjust TMJ Pressure Treatment, during the Arthroscopic treatment adjust the pressure of TMJ to normal value

Group Type ACTIVE_COMPARATOR

Adjust the TMJ Pressure to Normal Value

Intervention Type PROCEDURE

Adjust the TMJ Pressure by the Operation Only Once for Each Patient

5.The TMJ Orperation Treatment

The TMJ Operation Treatment without adjusting the pressure of TMJ

Group Type ACTIVE_COMPARATOR

Do not adjust the pressure of TMJ

Intervention Type OTHER

Do the treatments normally without additional treatment

6.The TMJ Operation with Adjust Pressure

The TMJ Operation with Adjust TMJ Pressure Treatment, during the treatments to adjust the TMJ pressure to normal value

Group Type ACTIVE_COMPARATOR

Adjust the TMJ Pressure to Normal Value

Intervention Type PROCEDURE

Adjust the TMJ Pressure by the Operation Only Once for Each Patient

7.Bite Plate Treatment

Bite Plate Treatment for Temporomandibular Disorders without adjusting the pressure of TMJ

Group Type ACTIVE_COMPARATOR

Do not adjust the pressure of TMJ

Intervention Type OTHER

Do the treatments normally without additional treatment

8.Bite Plate with Adjust pressure

Bite Plate and Adjust Pressure Treatment for Temporomandibular Disorders, during the treatments adjust the pressure of TMJ to normal value

Group Type ACTIVE_COMPARATOR

Adjust the TMJ Pressure to Normal Value

Intervention Type PROCEDURE

Adjust the TMJ Pressure by the Operation Only Once for Each Patient

2.Arthrocentesis with adjust pressure

Arthrocentesis with adjust pressure according to the pressure of TMJ

Group Type ACTIVE_COMPARATOR

Adjust the TMJ Pressure to Normal Value

Intervention Type PROCEDURE

Adjust the TMJ Pressure by the Operation Only Once for Each Patient

Interventions

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Adjust the TMJ Pressure to Normal Value

Adjust the TMJ Pressure by the Operation Only Once for Each Patient

Intervention Type PROCEDURE

Do not adjust the pressure of TMJ

Do the treatments normally without additional treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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zhang zhiguang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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zg zhang, Master

Role: STUDY_CHAIR

GUANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY

Locations

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Guanghua School of Stomatology and Hospital of Stomatology

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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zg zhang, Master

Role: CONTACT

8602083870387

Facility Contacts

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zg zhang, Master

Role: primary

8602083870387

Related Links

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http://www.zdkqyy.com

The Web Site of the Guanghua College of Stomatology Sun Yat-sun University

Other Identifiers

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SYSU-5010

Identifier Type: -

Identifier Source: org_study_id

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