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Temporomandibular Joint DysfunctionTMJNCT00636727

A Comparison of Arthrocentesis, Arthroscopy and Arthroplasty in the Treatment of Temporomandibular Joint Dysfunction

A study testing arthrocentesis, arthroscopy and arthroplasty in people with Temporomandibular Joint Dysfunction, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Many patients suffer from a disorder known as temporomandibular joint dysfunction. This disorder has jaw joint pain and limited function as key elements. Many treatments have been advocated over the last 40 years, many of them deleterious. Currently treatment can be divided into four categories. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Temporomandibular Joint Dysfunction
What is being tested?
arthrocentesis, arthroscopy and arthroplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
Jan 2007to Feb 2010
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients who require a surgical intervention

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Emory Clinic

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Many patients suffer from a disorder known as temporomandibular joint dysfunction. This disorder has jaw joint pain and limited function as key elements. Many treatments have been advocated over the last 40 years, many of them deleterious. Currently treatment can be divided into four categories. The first is non-surgical and involves vocal rest, soft diet, heat, anti-inflammatory medications, muscle relaxants, splint therapy and physical therapy. All patients benefit to some degree utilizing one or more non-surgical approaches. Controversy exists with respect to which of the next three categories of treatment is ideal. Some advocate arthrocentesis which involves placing two small needles into the joint to allow irrigation and instillation of anti-inflammatory medication. This is a minimally invasive procedure performed under local anesthetic alone or with intravenous sedation. Others advocate arthroscopy which involves placing an arthroscope (a thin tube about 2mm in diameter with optical elements allowing one to see inside a joint) to visualize the inside of a joint. Furthermore the joint can be irrigated, scar bands removed, ligaments stretched and medication instilled. This is performed under a general anesthesia. Depending on the study, success for both arthrocentesis and arthroscopy has been reported to be about 80-90%. Still there are others who recommend arthroplasty which is an open joint surgical procedure that allows the surgeon to enter the joint and directly repair or remove the damaged cartilage disc within the joint. This is performed under a general anesthesia. Similar success rates of 80-94% have been reported. It is clear that some patients only require arthrocentesis, others arthroscopy and others arthroplasty. We currently do not have any real mechanism of predicting which patients will benefit the most from which procedure.

This study will enable patients undergoing each procedure to be followed closely with the hope that we can determine objective factors that will allow us to stratify patients into one of the three surgical options: arthrocentesis, arthroscopy or arthroplasty. Our current approach is empiric and typically proceeds from arthrocentesis to arthroscopy to arthroplasty. All patients in this study will be offered the opportunity to have arthrocentesis performed. It is anticipated that a minority will achieve long-term benefit in terms of pain and function. We hope to be able to identify those factors which will predict which patients will benefit so that future patients selected to have arthrocentesis will have much higher success rates. Patients who fail to improve with arthrocentesis or who initially decline that procedure will be offered the opportunity to undergo arthroscopy. It is anticipated that a majority of patients will achieve long-term benefit in terms of pain and function. Again it is hoped that we can identify those factors which will predict which patients will benefit so that future patients selected to have arthroscopy will have even higher success rates. Patients who fail to improve with arthroscopy or who initially decline both arthrocentesis and arthroscopy will be offered the opportunity to undergo arthroplasty provided that clinical and radiographic evidence exists to support the presence of either a diseased or displaced cartilage disc.

Our ability to adequately treat patients with temporomandibular joint dysfunction will be significantly improved if we can better stratify patients and follow an evidence based surgical algorithm that provides the greatest opportunity for success while reducing potential complications. Each of these surgical procedures is the standard of care throughout the USA but unfortunately the choice of which procedure to perform is often empiric and guided more by training and surgical experience.

Being tested
arthrocentesis, arthroscopy, arthroplasty
Keywords
arthrocentesis, arthroscopy, arthroplasty
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.

  • arthrocentesisProcedure or surgery

    Irrigate the TMJ with lactated ringers

  • arthroscopyProcedure or surgery

    The TMJ will be inspected with an arthroscope and the joint irrigated with lactated ringers

  • arthroplastyProcedure or surgery

    The disc will be surgically repositioned with open surgery

Study groups in NCT00636727
Study groupRoleWhat they receive
1Active comparatorarthrocentesis
Receives: Procedure: arthrocentesis
2Active comparatorarthroscopy
Receives: Procedure: arthroscopy
3Active comparatorarthroplasty
Receives: Procedure: arthroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in pain

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2008 (estimated)
  2. Study startJan 2007
  3. Primary completionDec 2009
  4. Study completionFeb 2010

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00636727
Sponsor's protocol ID
IRB00000450
Acronym
TMJ
Status last verified
Nov 2013
First submitted
15 Feb 2008
Last updated
21 Nov 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing arthrocentesis, arthroscopy and arthroplasty in people with Temporomandibular Joint Dysfunction, run by Emory University at 1 site in United States.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Nov 2013. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in pain (time frame: 3 months). 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 21 Nov 2013.

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