Temporomandibular JointPhase 2NCT01471418
The Use of PET/CT to Evaluate Synovitis in the Temporomandibular Joint (TMJ)
A Phase 2 study testing PET/CT with 18-FDG in people with Temporomandibular Joint and Conservative Treatment Therapy, run by University of Pennsylvania at 1 site in United States.
Trial summary
Temporomandibular joint disorders (TMD) are a common musculoskeletal problem with an estimated 40-75 percent of the population reporting at least one sign. Up to fifteen percent of the patients who seek care for one of these conditions, will go on to develop chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint, Conservative Treatment Therapy
- What is being tested?
- PET/CT with 18-FDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Oct 2012
- Phase
- Phase 2
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Key inclusion criteria include any individual found to have a primary diagnosis of internal derangement of the temporomandibular joint requiring arthroscopy as determined by the treating physician.
- All patients will have failed a trial period of "conservative treatment therapy" including occlusal splint therapy, NSAIDs, or muscle relaxants for a period no less than eight weeks, as per standard of care.
- All patients will be between the ages of 18 and 70.
Who cannot join
- Exclusion criteria will include patients not medically stable to undergo arthroscopy under general anesthesia, patients with overlying infection of the skin, uncontrolled diabetes, patients with bilateral TMJ internal derangement, pregnancy, and patients with conditions other than internal derangement causing temporomandibular pain or dysfunction.
- Patients less than 18 or greater than 70 years of age will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Investigation of the Use of Positron Emission Tomography With 18F-FDG PET/CT for the Diagnosis of Synovitis in the Temporomandibular Joint
Temporomandibular joint disorders (TMD) are a common musculoskeletal problem with an estimated 40-75 percent of the population reporting at least one sign. Up to fifteen percent of the patients who seek care for one of these conditions, will go on to develop chronic pain. The two most common TMD conditions include myofascial pain disorder and internal derangement of the Temporomandibular Joint (TMJ). These two conditions have similar clinical presentations, making an accurate diagnosis difficult. Currently, there is no accurate exam or test to differentiate between these two conditions.
Internal derangement of the TMJ is a condition with disk displacement, pain, and dysfunction, which may progress to localized osteoarthritis. Fortunately, this condition is self-limiting for the majority of the patients afflicted, with a small minority progressing to advanced joint destruction, disability and chronic pain.18 Currently there are no prognostic indicators to identify these individuals. There are three hypothesis of degenerative TMJ disease, they include: direct mechanical trauma, hypoxia reperfusion injuries, and neurogenic inflammation. All involve parafunctional habits such as clenching or grinding by the patient and a low-grade inflammatory response/synovitis. 18-fluorodeoxyglucose (18-FDG), a radioisotope used with positron emission tomography (PET) and paired with a CT scan (PET/CT), may have a role in imaging inflammation in arthritis as recently demonstrated in several pilot studies involving osteoarthritis of the knee and shoulder. 18-FDG accumulates in areas of increased metabolism, particularly activated leukocytes, as measured by increased standardized uptake value.2 PET/CT offers the unique advantage of showing active disease before anatomic damage is evident. Our hypothesis is that there is an increased uptake of 18-FDG on PET/CT in synovitis of the TMJ.
Read the detailed description
This is a prospective, double-blinded, pilot study to evaluate the ability of PET/CT with FDG to detect synovitis of the temporomandibular joint. Patients presenting to the Department of Oral and Maxillofacial Surgery at the Hospital of the University of Pennsylvania with symptomatic internal derangement of the temporomandibular joint requiring arthroscopy will be compared to control subjects. Key inclusion criteria include any individual found to have a primary diagnosis of internal derangement of the temporomandibular joint requiring arthroscopy as determined by the treating physician. All patients will have failed a trial period of "conservative treatment therapy" including occlusal splint therapy, NSAIDs, or muscle relaxants for a period no less than eight weeks. Exclusion criteria will include patients not medically stable to undergo arthroscopy under general anesthesia, patients with overlying infection of the skin, patients with conditions other than internal derangement causing temporomandibular pain or dysfunction.
Once a patient has been identified as eligible for the study, the treating physician will contact a member of the study team. Each participating patient will undergo a standardized exam, the research diagnostic criteria for TMD (RDC/TMD). A member of the research team, from the department of oral medicine, will administer this exam. This standardized exam has been previously validated in the literature, and each member of the research team will undergo training and calibration prior to administering the RDC/TMD. This exam will be performed on the day of the arthroscopy. In addition, each patient will be given a Wilkes score, based on the Wilkes classification of internal derangement.36 The patient will then undergo arthroscopy of the temporomandibular joint as per the treating physician. TMJ arthroscopy includes: a small incision in front of the ear, introduction of an arthroscope and irrigation needle into the joint space, irrigation of fluid, and at the discretion of the treating physician may include the lysis of adhesion and the introduction of medication into the joint. At the time of the procedure, the synovitis score will be determined based on an eleven point synovitis scale as described by Murakami, with zero being absence of synovial inflammation. This scoring is bone by observation, and is typically include in the arthroscopy procedure for diagnosis. The patient will also be given a binomial score of presence or absence of synovitis. A representative photograph will be obtained of the patient's joint during arthroscopy, as is routinely done during this procedures.
Prior to the procedure, the patients will have undergone a PET/CT scan to evaluate the TMJ. This radiographic exam will be limited to the head and neck region in order to minimize radiation exposure. The radiologists reading the study will be blinded to the results of the clinical exam and condition. The results of the PET/CT study will be given as a binomial score of positive or negative and given a continuous score based on uptake relative to the unaffected joint.
Control subjects will undergo the RDC/TMD standardized exam prior to the radiographic study, and only have the PET/CT performed, with no subsequent intervention. These patients will be aged matched to the treatment subjects. This information will then be utilized to determine the utility of PET/CT in the detection of synovitis of the temporomandibular joint.
- Being tested
- PET/CT with 18-FDG
- Keywords
- TMJ, orofacial pain, synovitis, arthroscopy
- Medical subject headings
- Facial Pain, Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT with 18-FDGDrug
FDG uptake
| Study group | Role | What they receive |
|---|---|---|
| Disease population | Experimental | Not described Receives: Drug: PET/CT with 18-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome variable will be the presence or absence of 18F-FDG uptake on positron emission tomography combined with computed tomography (CT) of the temporomandibular joint.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Why it stopped: 29-Apr-14 UPENN IRB granted approval to close study due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular JointStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471418
- Sponsor's protocol ID
- 813671
- Status last verified
- Jul 2015
- First submitted
- 10 Nov 2011
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Use of Positron Emission Tomography With 18F-FDG PET/CT for the Diagnosis of Synovitis in the Temporomandibular Joint
- ClinicalTrials.gov ID
- NCT01471418
- Acronym / sponsor ID
- 813671
- Keywords
- TMJ, orofacial pain, synovitis, arthroscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 29-Apr-14 UPENN IRB granted approval to close study due to lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 16 Nov 2011 (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.
Temporomandibular joint disorders (TMD) are a common musculoskeletal problem with an estimated 40-75 percent of the population reporting at least one sign. Up to fifteen percent of the patients who seek care for one of these conditions, will go on to develop chronic pain. The two most common TMD conditions include myofascial pain disorder and internal derangement of the Temporomandibular Joint (TMJ). These two conditions have similar clinical presentations, making an accurate diagnosis difficult. Currently, there is no accurate exam or test to differentiate between these two conditions.
Internal derangement of the TMJ is a condition with disk displacement, pain, and dysfunction, which may progress to localized osteoarthritis. Fortunately, this condition is self-limiting for the majority of the patients afflicted, with a small minority progressing to advanced joint destruction, disability and chronic pain.18 Currently there are no prognostic indicators to identify these individuals. There are three hypothesis of degenerative TMJ disease, they include: direct mechanical trauma, hypoxia reperfusion injuries, and neurogenic inflammation. All involve parafunctional habits such as clenching or grinding by the patient and a low-grade inflammatory response/synovitis. 18-fluorodeoxyglucose (18-FDG), a radioisotope used with positron emission tomography (PET) and paired with a CT scan (PET/CT), may have a role in imaging inflammation in arthritis as recently demonstrated in several pilot studies involving osteoarthritis of the knee and shoulder. 18-FDG accumulates in areas of increased metabolism, particularly activated leukocytes, as measured by increased standardized uptake value.2 PET/CT offers the unique advantage of showing active disease before anatomic damage is evident. Our hypothesis is that there is an increased uptake of 18-FDG on PET/CT in synovitis of the TMJ.
Detailed description
This is a prospective, double-blinded, pilot study to evaluate the ability of PET/CT with FDG to detect synovitis of the temporomandibular joint. Patients presenting to the Department of Oral and Maxillofacial Surgery at the Hospital of the University of Pennsylvania with symptomatic internal derangement of the temporomandibular joint requiring arthroscopy will be compared to control subjects. Key inclusion criteria include any individual found to have a primary diagnosis of internal derangement of the temporomandibular joint requiring arthroscopy as determined by the treating physician. All patients will have failed a trial period of "conservative treatment therapy" including occlusal splint therapy, NSAIDs, or muscle relaxants for a period no less than eight weeks. Exclusion criteria will include patients not medically stable to undergo arthroscopy under general anesthesia, patients with overlying infection of the skin, patients with conditions other than internal derangement causing temporomandibular pain or dysfunction.
Once a patient has been identified as eligible for the study, the treating physician will contact a member of the study team. Each participating patient will undergo a standardized exam, the research diagnostic criteria for TMD (RDC/TMD). A member of the research team, from the department of oral medicine, will administer this exam. This standardized exam has been previously validated in the literature, and each member of the research team will undergo training and calibration prior to administering the RDC/TMD. This exam will be performed on the day of the arthroscopy. In addition, each patient will be given a Wilkes score, based on the Wilkes classification of internal derangement.36 The patient will then undergo arthroscopy of the temporomandibular joint as per the treating physician. TMJ arthroscopy includes: a small incision in front of the ear, introduction of an arthroscope and irrigation needle into the joint space, irrigation of fluid, and at the discretion of the treating physician may include the lysis of adhesion and the introduction of medication into the joint. At the time of the procedure, the synovitis score will be determined based on an eleven point synovitis scale as described by Murakami, with zero being absence of synovial inflammation. This scoring is bone by observation, and is typically include in the arthroscopy procedure for diagnosis. The patient will also be given a binomial score of presence or absence of synovitis. A representative photograph will be obtained of the patient's joint during arthroscopy, as is routinely done during this procedures.
Prior to the procedure, the patients will have undergone a PET/CT scan to evaluate the TMJ. This radiographic exam will be limited to the head and neck region in order to minimize radiation exposure. The radiologists reading the study will be blinded to the results of the clinical exam and condition. The results of the PET/CT study will be given as a binomial score of positive or negative and given a continuous score based on uptake relative to the unaffected joint.
Control subjects will undergo the RDC/TMD standardized exam prior to the radiographic study, and only have the PET/CT performed, with no subsequent intervention. These patients will be aged matched to the treatment subjects. This information will then be utilized to determine the utility of PET/CT in the detection of synovitis of the temporomandibular joint.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disease population | Experimental | Drug: PET/CT with 18-FDG |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Key inclusion criteria include any individual found to have a primary diagnosis of internal derangement of the temporomandibular joint requiring arthroscopy as determined by the treating physician.
- All patients will have failed a trial period of "conservative treatment therapy" including occlusal splint therapy, NSAIDs, or muscle relaxants for a period no less than eight weeks, as per standard of care.
- All patients will be between the ages of 18 and 70.
Key exclusion criteria (2 listed)
- Exclusion criteria will include patients not medically stable to undergo arthroscopy under general anesthesia, patients with overlying infection of the skin, uncontrolled diabetes, patients with bilateral TMJ internal derangement, pregnancy, and patients with conditions other than internal derangement causing temporomandibular pain or dysfunction.
- Patients less than 18 or greater than 70 years of age will also be excluded.
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 |
|---|---|---|
| PET/CT with 18-FDGFDG uptake | Drug | Disease population |
Primary outcome
The primary outcome variable will be the presence or absence of 18F-FDG uptake on positron emission tomography combined with computed tomography (CT) of the temporomandibular joint.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PET/CT with 18-FDG in people with Temporomandibular Joint and Conservative Treatment Therapy, run by University of Pennsylvania 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 8 Jul 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary outcome variable will be the presence or absence of 18F-FDG uptake on positron emission tomography combined with computed tomography (CT) of the temporomandibular joint. (time frame: 1 year). 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 8 Jul 2015.