NCT00932594

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jan 2006Dec 2026

Study Start

First participant enrolled

January 1, 2006

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

12.9 years

First QC Date

June 29, 2009

Last Update Submit

May 19, 2015

Conditions

Temporomandibular Disorder

Keywords

Create the New Serial Treatment of TMDPromote the Classification of Biodynamics in the TMDEvaluate the Effect of Adjusting TMJ TreatmentEstablish the New Standard of the TMJ TreatmentInvent New Device to Measure Pressure without Trauma

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    24 hours

Study Arms (8)

1.Arthrocentesis only

ACTIVE COMPARATOR

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

Other: Do not adjust the pressure of TMJ

3.Arthroscopic Treatment

ACTIVE COMPARATOR

Patient receives Arthroscopic treatments without adjusting the TMJ pressure

Other: Do not adjust the pressure of TMJ

4.Arthroscopic with Adjust Pressure

ACTIVE COMPARATOR

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

5.The TMJ Orperation Treatment

ACTIVE COMPARATOR

The TMJ Operation Treatment without adjusting the pressure of TMJ

Other: Do not adjust the pressure of TMJ

6.The TMJ Operation with Adjust Pressure

ACTIVE COMPARATOR

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

7.Bite Plate Treatment

ACTIVE COMPARATOR

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

Other: Do not adjust the pressure of TMJ

8.Bite Plate with Adjust pressure

ACTIVE COMPARATOR

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

2.Arthrocentesis with adjust pressure

ACTIVE COMPARATOR

Arthrocentesis with adjust pressure according to the pressure of TMJ

Procedure: Adjust the TMJ Pressure to Normal Value

Interventions

Adjust the TMJ Pressure to Normal ValuePROCEDURE

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

2.Arthrocentesis with adjust pressure4.Arthroscopic with Adjust Pressure6.The TMJ Operation with Adjust Pressure8.Bite Plate with Adjust pressure
Do not adjust the pressure of TMJOTHER

Do the treatments normally without additional treatment

1.Arthrocentesis only3.Arthroscopic Treatment5.The TMJ Orperation Treatment7.Bite Plate Treatment

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guanghua School of Stomatology and Hospital of Stomatology

Guangzhou, Guangdong, China

RECRUITING

Related Links

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • zg zhang, Master

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

    STUDY CHAIR

Central Study Contacts

zg zhang, Master

CONTACT

8602083870387drzhangzg@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 29, 2009

First Posted

July 3, 2009

Study Start

January 1, 2006

Primary Completion

December 1, 2018

Study Completion (Estimated)

December 1, 2026

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

CN(1)