Temporomandibular Joint DisordersPhase 1TMJNCT02202070
Botox for Treatment of TMJ Disorder With Bruxism
A Phase 1 study testing onabotulinumtoxinA in people with Temporomandibular Joint Disorders and Bruxism, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Hypothesis: Myofascial temporomandibular joint disorder and related symptoms are associated with mandibular condyle and temporal fossa overloading secondary to temporalis and masseter muscle hyperactivity and spasm This study will examine the use of onabotulinumtoxinA (Botox) to treat myofascial pain disorder in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Bruxism, Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- onabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2015
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-65 persons with a diagnosis of myofascial temporomandibular joint disorder refractory to conservative treatment for 6 months
Who cannot join
- pregnancy
- rheumatoid arthritis
- ankylosing spondylitis
- psoriatic arthritis
- fibromyalgia
- neuropathic pain
Show all 12Show fewer
- pain of dental origin
- muscle relaxant use
- aminoglycoside use
- prior Botox use
- neuropathic pain
- trigeminal neuralgia
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Phase 1 Study of Role of Botox in Myofascial Temporomandibular Disorder
Hypothesis: Myofascial temporomandibular joint disorder and related symptoms are associated with mandibular condyle and temporal fossa overloading secondary to temporalis and masseter muscle hyperactivity and spasm
This study will examine the use of onabotulinumtoxinA (Botox) to treat myofascial pain disorder in patients with bruxism who frequently exhibit signs of temporomandibular joint disorder (TMD) in a double blind cross-over randomized clinical trial by injecting 50 units Botox in temporalis and masseter muscles in 32 patients with 6 months follow up.
The objective of the proposed study will be to establish the safety and efficacy of botox in treating TMD associated with bruxism. By the time patients reach the specialists office, most have failed maximal conservative therapies, including non-chew diet, night guard, oral analgesics, muscle relaxants, physical therapy, and a portion have even undergone more invasive procedures, such as manipulation under anesthesia, arthroscopy, and arthroplasty surgeries with limited improvement or recurrence. Primary outcome of the study will be 50% reduction in pain. Secondary outcomes will be 50% reduction in surgical therapy, 25% increase in maximal inter-incisal opening (MIO). The investigators look forward to working with you on the proposed study
Read the detailed description
The study will enroll 32 patients with myofascial TMD. Patient will be aged 18-65. Exclusion criteria will include neuromuscular diseases, prior botox injections within previous 12 months, pregnancy, and fibromyalgia. All patients will be selected from the outpatient clinic, complaining of TMJ disease associated with bruxism. Screening will include a thorough history and exam, and TMJ CT scan or MRI. Patients with neuromuscular disorders, musculoskeletal disorders, and prior Botox injections will be excluded. Patients who have not already undergone conservative treatment will be managed with 3 months conservative therapies prior to becoming eligible. All patients will be informed and consented for participation in the study and Botox injections. Baseline pain questionnaire, physical exam will be performed. Patients will be randomized to receive normal saline or botox injections. All patients will crossover for the second set of injections at 3 months. All patients will receive up to a total of 200 Botox units at either 0 or 3 month time points. In this regard, patients will act as their own placebo control. Botox will be prepared according to the manufacturer's instructions. Briefly, the lyophilized protein will be reconstituted with preservative-free normal saline and drawn into 1-mL syringe. While the patient is sitting in the office procedure chair, 25 to 50 U of Botox will be injected into each temporalis muscle and 25 to 50 U of Botox will be injected into the each masseter muscle. The patient will be instructed to keep head elevated for 8 hours. Patients will be called 3 times after the first round of injections, to monitor for adverse events. Patients will be seen in clinic at 3 months and asked to fill out a second pain questionnaire. They will also undergo second physical exam, and then receive a second set of injections (crossover). Patients will be seen in clinic at 6 months and asked to fill out a third pain questionnaire undergo third physical exam. Patients will be called 3 times after the second round of injections, to monitor for adverse events. Patients will be seen in clinic at 6 months and asked to fill out a third pain questionnaire undergo a third physical exam
- Conditions
- Temporomandibular Joint Disorders, Bruxism, Temporomandibular Joint Dysfunction Syndrome, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
- Being tested
- onabotulinumtoxinA
- Keywords
- onabotulinumtoxinA, Temporomandibular Joint Disorders, Bruxism, Temporomandibular Joint Dysfunction Syndrome, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
- Medical subject headings
- Temporomandibular Joint Disorders, Bruxism, Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinumtoxinADrug
Also called BOTOX
| Study group | Role | What they receive |
|---|---|---|
| Botox injection first, followed by placebo | Experimental | 50 units Botox injection in masseter and temporalis muscles in the first 3 months, then second injection of normal saline at placebo in second 3 months Receives: Drug: onabotulinumtoxinA |
| Placebo injection first, followed Botox | Experimental | Injection of normal saline at placebo in first 3 months, then 50 units Botox injection in masseter and temporalis muscles in the second 3 months. Receives: Drug: onabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
50% reduction in pain
Patients will be seen in clinic every 3 months and asked to fill out questionaire. Questionaire will include with visual analogue scale (VAS) average pain over previous week, month
Measured: 6 months
Secondary outcomes (1)
25% increase in maximal opening at incisors
Patients will be seen in clinic every 3 months. Providers will objectively measure maximal opening at incisors (MOI), lateral and anterior mandible excursion on clinical exam.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethan Baughman, Washington University School of Medicine
- Investigators
- Alan A Harvey, DMD, Principal investigator, Assistant Professor, Department of Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202070
- Sponsor's protocol ID
- AAHEJB
- Acronym
- TMJ
- Status last verified
- Jan 2018
- First submitted
- 22 Jul 2014
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Role of Botox in Myofascial Temporomandibular Disorder
- ClinicalTrials.gov ID
- NCT02202070
- Acronym / sponsor ID
- TMJ / AAHEJB
- Conditions
- Temporomandibular Joint Disorders, Bruxism, Temporomandibular Joint Dysfunction Syndrome, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
- Keywords
- onabotulinumtoxinA, Temporomandibular Joint Disorders, Bruxism, Temporomandibular Joint Dysfunction Syndrome, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Jul 2014 (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.
Hypothesis: Myofascial temporomandibular joint disorder and related symptoms are associated with mandibular condyle and temporal fossa overloading secondary to temporalis and masseter muscle hyperactivity and spasm
This study will examine the use of onabotulinumtoxinA (Botox) to treat myofascial pain disorder in patients with bruxism who frequently exhibit signs of temporomandibular joint disorder (TMD) in a double blind cross-over randomized clinical trial by injecting 50 units Botox in temporalis and masseter muscles in 32 patients with 6 months follow up.
The objective of the proposed study will be to establish the safety and efficacy of botox in treating TMD associated with bruxism. By the time patients reach the specialists office, most have failed maximal conservative therapies, including non-chew diet, night guard, oral analgesics, muscle relaxants, physical therapy, and a portion have even undergone more invasive procedures, such as manipulation under anesthesia, arthroscopy, and arthroplasty surgeries with limited improvement or recurrence. Primary outcome of the study will be 50% reduction in pain. Secondary outcomes will be 50% reduction in surgical therapy, 25% increase in maximal inter-incisal opening (MIO). The investigators look forward to working with you on the proposed study
Detailed description
The study will enroll 32 patients with myofascial TMD. Patient will be aged 18-65. Exclusion criteria will include neuromuscular diseases, prior botox injections within previous 12 months, pregnancy, and fibromyalgia. All patients will be selected from the outpatient clinic, complaining of TMJ disease associated with bruxism. Screening will include a thorough history and exam, and TMJ CT scan or MRI. Patients with neuromuscular disorders, musculoskeletal disorders, and prior Botox injections will be excluded. Patients who have not already undergone conservative treatment will be managed with 3 months conservative therapies prior to becoming eligible. All patients will be informed and consented for participation in the study and Botox injections. Baseline pain questionnaire, physical exam will be performed. Patients will be randomized to receive normal saline or botox injections. All patients will crossover for the second set of injections at 3 months. All patients will receive up to a total of 200 Botox units at either 0 or 3 month time points. In this regard, patients will act as their own placebo control. Botox will be prepared according to the manufacturer's instructions. Briefly, the lyophilized protein will be reconstituted with preservative-free normal saline and drawn into 1-mL syringe. While the patient is sitting in the office procedure chair, 25 to 50 U of Botox will be injected into each temporalis muscle and 25 to 50 U of Botox will be injected into the each masseter muscle. The patient will be instructed to keep head elevated for 8 hours. Patients will be called 3 times after the first round of injections, to monitor for adverse events. Patients will be seen in clinic at 3 months and asked to fill out a second pain questionnaire. They will also undergo second physical exam, and then receive a second set of injections (crossover). Patients will be seen in clinic at 6 months and asked to fill out a third pain questionnaire undergo third physical exam. Patients will be called 3 times after the second round of injections, to monitor for adverse events. Patients will be seen in clinic at 6 months and asked to fill out a third pain questionnaire undergo a third physical exam
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox injection first, followed by placebo | Experimental | Drug: onabotulinumtoxinA50 units Botox injection in masseter and temporalis muscles in the first 3 months, then second injection of normal saline at placebo in second 3 months |
| Placebo injection first, followed Botox | Experimental | Drug: onabotulinumtoxinAInjection of normal saline at placebo in first 3 months, then 50 units Botox injection in masseter and temporalis muscles in the second 3 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 18-65 persons with a diagnosis of myofascial temporomandibular joint disorder refractory to conservative treatment for 6 months
Key exclusion criteria (12 listed)
- pregnancy
- rheumatoid arthritis
- ankylosing spondylitis
- psoriatic arthritis
- fibromyalgia
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 |
|---|---|---|
| onabotulinumtoxinAAlso: BOTOX | Drug | Botox injection first, followed by placebo, Placebo injection first, followed Botox |
Primary outcome
50% reduction in pain
Time frame: 6 months
Patients will be seen in clinic every 3 months and asked to fill out questionaire. Questionaire will include with visual analogue scale (VAS) average pain over previous week, month
1 secondary outcome
25% increase in maximal opening at incisors
Time frame: 6 months
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 23 Jan 2018.
Related trials for Temporomandibular Joint Disorders
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
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.
Alan A Harvey, DMD principal investigator
Assistant Professor, Department of Otolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing onabotulinumtoxinA in people with Temporomandibular Joint Disorders and Bruxism, run by Washington University School of Medicine 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 12 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 23 Jan 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
50% reduction in pain (time frame: 6 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 23 Jan 2018.