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

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

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Key information

Conditions

Temporomandibular Joint Disorders Craniomandibular Disorders Facial Pain Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Dysfunction Syndrome

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthrocentesis

Procedure

Temporomandibular joint (TMJ) arthrocentesis will be performed under local anesthesia using a standard two-needle technique. Two needles will be inserted into the superior joint space, and the joint will be irrigated with sterile isotonic solution (e.g., Ringer's lactate or normal saline, approximately 100-300 mL) to lavage inflammatory mediators and break minor intra-articular adhesions. The procedure will be performed as a single session by a trained oral and maxillofacial surgeon. Patients will be advised to follow a soft diet and may receive standard analgesics as needed following the procedure.

Other names: lavage

Botulinum Toxin-A

Drug

Botulinum toxin type A (Botox) will be injected intramuscularly into the masseter and temporalis muscles bilaterally. Injection sites will be determined by palpation of muscle bulk and activity during voluntary contraction (patients will be asked to clench their teeth to identify the muscle borders and the point of maximal bulk/tenderness).

The total dose will be 25-50 units per masseter muscle and 10-25 units per temporalis muscle, administered as a single session.

The procedure will be performed by a trained physician experienced in botulinum toxin injection technique.

Patients will be monitored for the onset of muscle relaxation effects, expected within days to weeks following injection.

Primary outcomes

Change in Pain Intensity Measured by Visual Analog Scale (VAS)

Time frame: Baseline, 1 month, 3 months, and 6 months post-treatment

Pain intensity in the temporomandibular joint region will be measured using a Visual Analog Scale (VAS), a 0-10 point continuous scale where 0 indicates no pain and 10 indicates the worst pain imaginable. Participants will rate their pain at rest and during jaw movement/chewing at each study visit.

The change in VAS score from baseline to 6 months will be compared between the arthrocentesis and botulinum toxin injection groups.

Sponsors and collaborators

Lead sponsor

Mudher MB Alsunbuli

Other

Collaborators

Al-Bayan University

Registry information

Acronym: RCT

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Jul 30, 2026
Registry last updated: Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed