Arthrocentesis Versus Botulinum Toxin Injection in Patients With Temporomandibular Joint Disorder… (NCT07736521) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Arthrocentesis Versus Botulinum Toxin Injection in Patients With Temporomandibular Joint Disorders: A Randomized Controlled Trial
66 participantsStarted 2026-08-15
Plain-language summary
The goal of this clinical trial is to learn if arthrocentesis works as well as botulinum toxin (Botox) injection to treat pain and jaw dysfunction in adults with temporomandibular joint (TMJ) disorders.
The main questions it aims to answer are:
* Does arthrocentesis reduce pain more, less, or the same as Botox injection?
* Does arthrocentesis improve jaw opening and function more, less, or the same as Botox injection?
* What side effects do participants have with each treatment?
Researchers will compare arthrocentesis to Botox injection to see which treatment works better for reducing pain and improving jaw movement in patients with TMJ disorders.
Participants will:
* Be randomly assigned to receive either arthrocentesis (a joint-washing procedure) or a Botox injection into the jaw muscles
* Visit the clinic at 1, 3, and 6 months after treatment for checkups and assessments - Rate their pain and have their jaw movement measured at each visit
* Complete short questionnaires about their jaw function and quality of life
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinically and radiographically confirmed temporomandibular joint (TMJ) disorder, diagnosed according to Wilkes staging or the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
* Age 18 years or older
* Symptom duration of at least 3 months
* Unresponsive to conservative therapy
* Willing and able to provide written informed consent
Exclusion Criteria:
* Previous TMJ surgery
* Systemic rheumatic/inflammatory joint disease (e.g., rheumatoid arthritis, ankylosing spondylitis)
* Bony ankylosis of the TMJ
* Pregnancy
* Known allergy or contraindication to botulinum toxin
* Concurrent use of muscle relaxants, corticosteroids, or anticoagulant medication that may confound treatment effects
* Unwillingness or inability to attend scheduled follow-up visits
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Timeframe: Baseline, 1 month, 3 months, and 6 months post-treatment