The New Serial Treatment of Temporomandibular Disorders

May 19, 2015 updated by: zhang zhiguang, Sun Yat-sen University

Create the New Serial Treatment of Temporomandibular Disorders

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

4

Phase

  • Not Applicable

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

    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guanghua School of Stomatology and Hospital of Stomatology
        • 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

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1.Arthrocentesis only
Patients only have Arthrocentesis, but without adjusting the pressure of the TMJ
Do the treatments normally without additional treatment
Active Comparator: 3.Arthroscopic Treatment
Patient receives Arthroscopic treatments without adjusting the TMJ pressure
Do the treatments normally without additional treatment
Active Comparator: 4.Arthroscopic with Adjust Pressure
Arthroscopic Treatment with Adjust TMJ Pressure Treatment, during the Arthroscopic treatment adjust the pressure of TMJ to normal value
Adjust the TMJ Pressure by the Operation Only Once for Each Patient
Active Comparator: 5.The TMJ Orperation Treatment
The TMJ Operation Treatment without adjusting the pressure of TMJ
Do the treatments normally without additional treatment
Active Comparator: 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
Adjust the TMJ Pressure by the Operation Only Once for Each Patient
Active Comparator: 7.Bite Plate Treatment
Bite Plate Treatment for Temporomandibular Disorders without adjusting the pressure of TMJ
Do the treatments normally without additional treatment
Active Comparator: 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
Adjust the TMJ Pressure by the Operation Only Once for Each Patient
Active Comparator: 2.Arthrocentesis with adjust pressure
Arthrocentesis with adjust pressure according to the pressure of TMJ
Adjust the TMJ Pressure by the Operation Only Once for Each Patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause mortality
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Investigators

  • Study Chair: zg zhang, Master, GUANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

January 1, 2006

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

July 2, 2009

First Posted (Estimate)

July 3, 2009

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

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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