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The New Serial Treatment of Temporomandibular Disorders

This study is currently recruiting participants.
Verified April 2013 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
zhang zhiguang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00932594
First received: June 29, 2009
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Temporomandibular Disorder
 Procedure: Adjust the TMJ Pressure to Normal Value
Other: Do not adjust the pressure of TMJ

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Create the New Serial Treatment of Temporomandibular Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 4
Study Start Date: January 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1.Arthrocentesis only
Patients only have Arthrocentesis, but without adjusting the pressure of the TMJ
 Other: Do not adjust the pressure of TMJ
Do the treatments normally without additional treatment
Active Comparator: 3.Arthroscopic Treatment
Patient receives Arthroscopic treatments without adjusting the TMJ pressure
 Other: Do not adjust the pressure of TMJ
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
 Procedure: Adjust the TMJ Pressure 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
 Other: Do not adjust 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
 Procedure: 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
 Other: Do not adjust 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
 Procedure: Adjust the TMJ Pressure 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
 Procedure: Adjust the TMJ Pressure to Normal Value
Adjust the TMJ Pressure by the Operation Only Once for Each Patient

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.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932594

Contacts
Contact: zg zhang, Master 8602083870387 drzhangzg@163.com

Locations
China, Guangdong
Guanghua School of Stomatology and Hospital of Stomatology Recruiting
Guangzhou, Guangdong, China
Contact: zg zhang, Master     8602083870387     drzhangzg@163.com    
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Chair: zg zhang, Master GUANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY
  More Information

Additional Information:
The Web Site of the Guanghua College of Stomatology Sun Yat-sun University  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: zhang zhiguang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00932594     History of Changes
Other Study ID Numbers: SYSU-5010
Study First Received: June 29, 2009
Last Updated: April 10, 2013
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
Create the New Serial Treatment of TMD
Promote the Classification of Biodynamics in the TMD
Evaluate the Effect of Adjusting TMJ Treatment
Establish the New Standard of the TMJ Treatment
Invent New Device to Measure Pressure without Trauma

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
 Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes

ClinicalTrials.gov processed this record on May 16, 2013