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The New Serial Treatment of Temporomandibular Disorders

Primary Purpose

Temporomandibular Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Adjust the TMJ Pressure to Normal Value
Do not adjust the pressure of TMJ
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring 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

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guanghua School of Stomatology and Hospital of StomatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1.Arthrocentesis only

3.Arthroscopic Treatment

4.Arthroscopic with Adjust Pressure

5.The TMJ Orperation Treatment

6.The TMJ Operation with Adjust Pressure

7.Bite Plate Treatment

8.Bite Plate with Adjust pressure

2.Arthrocentesis with adjust pressure

Arm Description

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

Patient receives Arthroscopic treatments without adjusting the TMJ pressure

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

The TMJ Operation Treatment without adjusting the pressure of TMJ

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

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

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

Arthrocentesis with adjust pressure according to the pressure of TMJ

Outcomes

Primary Outcome Measures

all cause mortality

Secondary Outcome Measures

Full Information

First Posted
June 29, 2009
Last Updated
May 19, 2015
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT00932594
Brief Title
The New Serial Treatment of Temporomandibular Disorders
Official Title
Create the New Serial Treatment of Temporomandibular Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Recruiting
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1.Arthrocentesis only
Arm Type
Active Comparator
Arm Description
Patients only have Arthrocentesis, but without adjusting the pressure of the TMJ
Arm Title
3.Arthroscopic Treatment
Arm Type
Active Comparator
Arm Description
Patient receives Arthroscopic treatments without adjusting the TMJ pressure
Arm Title
4.Arthroscopic with Adjust Pressure
Arm Type
Active Comparator
Arm Description
Arthroscopic Treatment with Adjust TMJ Pressure Treatment, during the Arthroscopic treatment adjust the pressure of TMJ to normal value
Arm Title
5.The TMJ Orperation Treatment
Arm Type
Active Comparator
Arm Description
The TMJ Operation Treatment without adjusting the pressure of TMJ
Arm Title
6.The TMJ Operation with Adjust Pressure
Arm Type
Active Comparator
Arm Description
The TMJ Operation with Adjust TMJ Pressure Treatment, during the treatments to adjust the TMJ pressure to normal value
Arm Title
7.Bite Plate Treatment
Arm Type
Active Comparator
Arm Description
Bite Plate Treatment for Temporomandibular Disorders without adjusting the pressure of TMJ
Arm Title
8.Bite Plate with Adjust pressure
Arm Type
Active Comparator
Arm Description
Bite Plate and Adjust Pressure Treatment for Temporomandibular Disorders, during the treatments adjust the pressure of TMJ to normal value
Arm Title
2.Arthrocentesis with adjust pressure
Arm Type
Active Comparator
Arm Description
Arthrocentesis with adjust pressure according to the pressure of TMJ
Intervention Type
Procedure
Intervention Name(s)
Adjust the TMJ Pressure to Normal Value
Intervention Description
Adjust the TMJ Pressure by the Operation Only Once for Each Patient
Intervention Type
Other
Intervention Name(s)
Do not adjust the pressure of TMJ
Intervention Description
Do the treatments normally without additional treatment
Primary Outcome Measure Information:
Title
all cause mortality
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zg zhang, Master
Phone
8602083870387
Email
drzhangzg@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zg zhang, Master
Organizational Affiliation
GUANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY
Official's Role
Study Chair
Facility Information:
Facility Name
Guanghua School of Stomatology and Hospital of Stomatology
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zg zhang, Master
Phone
8602083870387
Email
drzhangzg@163.com

12. IPD Sharing Statement

Links:
URL
http://www.zdkqyy.com
Description
The Web Site of the Guanghua College of Stomatology Sun Yat-sun University

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The New Serial Treatment of Temporomandibular Disorders

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