- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00932594
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: zg zhang, Master
- Phone Number: 8602083870387
- Email: drzhangzg@163.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Recruiting
- Guanghua School of Stomatology and Hospital of Stomatology
-
Contact:
- zg zhang, Master
- Phone Number: 8602083870387
- Email: drzhangzg@163.com
-
-
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSU-5010
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