Temporomandibular DisorderNCT00932594
The New Serial Treatment of Temporomandibular Disorders
A study testing Adjust the TMJ Pressure to Normal Value and Do not adjust the pressure of TMJ in people with Temporomandibular Disorder, run by Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Adjust the TMJ Pressure to Normal Value and Do not adjust the pressure of TMJ
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- Jan 2006to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 10Show fewer
- Dislocation of the Temporomandibular Disc
- Bone of the Temporomandibular Joint Changement
- Patient in the Age of 16-60
- Voluntary Patient
Who cannot join
- Dysimmunity Disease
- Dysfunction of Heart Liver and Kidney Disease
- Patient can not do the Guide Line
- Life-threatening Patient
- Serious Limited Mouth Opening
- Epilepsy
Show all 9Show fewer
- Tetanus
- Pregnancy or Women in the Pregnancy Period
- Supportive Temporomandibular Disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guanghua School of Stomatology and Hospital of Stomatology
Guangzhou, Guangdong
zg zhang, Master, 8602083870387, drzhangzg@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Temporomandibular Disorder
- Being tested
- Adjust the TMJ Pressure to Normal Value, Do not adjust the pressure of TMJ
- 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
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjust the TMJ Pressure to Normal ValueProcedure or surgery
Adjust the TMJ Pressure by the Operation Only Once for Each Patient
Do not adjust the pressure of TMJOther
Do the treatments normally without additional treatment
| Study group | Role | What they receive |
|---|---|---|
| 1.Arthrocentesis only | Active comparator | Patients only have Arthrocentesis, but without adjusting the pressure of the TMJ Receives: Other: Do not adjust the pressure of TMJ |
| 3.Arthroscopic Treatment | Active comparator | Patient receives Arthroscopic treatments without adjusting the TMJ pressure Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: Adjust the TMJ Pressure to Normal Value |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startJan 2006
- Primary completionDec 2018 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhang zhiguang, Sun Yat-sen University
- Investigators
- zg zhang, Master, Study chair, GUANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932594
- Sponsor's protocol ID
- SYSU-5010
- Status last verified
- May 2015
- First submitted
- 29 Jun 2009
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Create the New Serial Treatment of Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT00932594
- Acronym / sponsor ID
- SYSU-5010
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1.Arthrocentesis only | Active comparator | Other: Do not adjust the pressure of TMJPatients only have Arthrocentesis, but without adjusting the pressure of the TMJ |
| 3.Arthroscopic Treatment | Active comparator | Other: Do not adjust the pressure of TMJPatient receives Arthroscopic treatments without adjusting the TMJ pressure |
| 4.Arthroscopic with Adjust Pressure | Active comparator | Procedure: Adjust the TMJ Pressure to Normal ValueArthroscopic Treatment with Adjust TMJ Pressure Treatment, during the Arthroscopic treatment adjust the pressure of TMJ to normal value |
| 5.The TMJ Orperation Treatment | Active comparator | Other: Do not adjust the pressure of TMJThe TMJ Operation Treatment without adjusting the pressure of TMJ |
| 6.The TMJ Operation with Adjust Pressure | Active comparator | Procedure: Adjust the TMJ Pressure to Normal ValueThe TMJ Operation with Adjust TMJ Pressure Treatment, during the treatments to adjust the TMJ pressure to normal value |
| 7.Bite Plate Treatment | Active comparator | Other: Do not adjust the pressure of TMJBite Plate Treatment for Temporomandibular Disorders without adjusting the pressure of TMJ |
| 8.Bite Plate with Adjust pressure | Active comparator | Procedure: Adjust the TMJ Pressure to Normal ValueBite Plate and Adjust Pressure Treatment for Temporomandibular Disorders, during the treatments adjust the pressure of TMJ to normal value |
| 2.Arthrocentesis with adjust pressure | Active comparator | Procedure: Adjust the TMJ Pressure to Normal ValueArthrocentesis with adjust pressure according to the pressure of TMJ |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Limited Month Opening
- Abnormal of the Month Opening Type
- Paint During the Month Open or Close
- Condylar Position Paint
- Clicking of the Temporomandibular Joint
Key exclusion criteria (9 listed)
- Dysimmunity Disease
- Dysfunction of Heart Liver and Kidney Disease
- Patient can not do the Guide Line
- Life-threatening Patient
- Serious Limited Mouth Opening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjust the TMJ Pressure to Normal ValueAdjust the TMJ Pressure by the Operation Only Once for Each Patient | Procedure or surgery | 2.Arthrocentesis with adjust pressure, 4.Arthroscopic with Adjust Pressure, 6.The TMJ Operation with Adjust Pressure, 8.Bite Plate with Adjust pressure |
| Do not adjust the pressure of TMJDo the treatments normally without additional treatment | Other | 1.Arthrocentesis only, 3.Arthroscopic Treatment, 5.The TMJ Orperation Treatment, 7.Bite Plate Treatment |
Primary outcome
all cause mortality
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- The Web Site of the Guanghua College of Stomatology Sun Yat-sun UniversityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
zg zhang, Master study chair
GUANGHUA SHOOL OF STOMATOLOGY and HOSPITAL OF STOMATOLOGY SUN YAT-SEN UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjust the TMJ Pressure to Normal Value and Do not adjust the pressure of TMJ in people with Temporomandibular Disorder, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zg zhang, Master (8602083870387, drzhangzg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.