Arthrocentesis Versus Botulinum Toxin Injection in Patients With Temporomandibular Joint Disorders: A Randomized Controlled Trial

Starting soon · Not applicable

Conditions studied: Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Facial Pain

In brief

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

Key facts

Study ID

NCT07736521

Run by

Mudher MB Alsunbuli

People needed

66

Starts

2026-08-15

Expected to finish

2027-05-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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