Using Botulinumtoxin A to treat pain in jaw disorders
Official title: Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders - a Quality Study Associated to a New Treatment Routine
Run by Region Stockholm · NCT06941636 · Data updated 2026-11-12
This study is testing if Botulinumtoxin A injections can help reduce pain and improve life for people with jaw disorders caused by muscle issues.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | April 24, 2025 |
| Trial ID | NCT06941636 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with myalgia or myofascial pain related to temporomandibular disorders, experiencing moderate to severe pain for over three months.
✕Probably not a fit
Patients with systemic inflammatory diseases, widespread pain conditions, or those who have received recent treatments for orofacial pain may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of Botulinumtoxin A (BTX) injections in the masseter and temporal muscles for patients suffering from myogenous temporomandibular disorders (TMD). The primary goal is to determine if BTX can reduce pain and improve quality of life, while also exploring whether the effects are dose-dependent. Additionally, the study aims to identify differences in treatment outcomes among various sub-groups of myogenous TMD to personalize pain management strategies.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate pain and enhance the quality of life for patients with myogenous TMD.
How similar studies have gone: Previous studies have shown promising results with BTX for pain management in similar conditions, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Has given a written consent * Diagnose of myalgia, myofacial pain or myofascial pain with referred pain according * Average pain due to NRS ≥ 3 for more than three months * Palpationpain in masseter or temporalis. * Eventual treatment for orofacial pain \> three months ago. * Adequate contraceptives and a negative pregnancy test. Patients will still be included even if they have one or more co-diagnoses * Discdisplacement with or without reduction * Degenerative joint disease * Arthralgia Exclusion Criteria: * Treatment with BTX during the last 12 months * Treatment for orofacial pain within the last 3 months. * Systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) * Widespread pain e.g., fibromyalgia * Neuropathic pain * Neurologic disease (myasthenia gravis) * Pain of dental origin * Use of muscle relaxants, or aminoglycoside antibiotics * Pregnancy or nursing * Hypersensitivity to BTX * Neuropsychiatric conditions. * Difficulties understanding the Swedish language
Where it's running
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Eastman institute Folktandvården Region Stockholm
Stockholm, Sweden Recruiting
Study contacts
- Principal investigator: Veronica de Flon — Region Stockholm
- Study coordinator: Veronica de Flon
- Email: veronica.deflon@regionstockholm.se
- Phone: + 46 702182623
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Botulinum toxin for jaw myofascial pain in adults
This study tests whether injecting botulinum toxin into jaw muscles helps reduce pain and improve mouth opening in adults with stubborn temporomandibular myofascial pain.
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What predicts how bad TMD is, involving jaw, neck, and posture
We will test if jaw dysfunction, neck position sense, and head/neck posture relate to how severe temporomandibular disorders are in adults.
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Nerivio in adults and adolescents with chronic TMD headache
This study tests a Nerivio device to help people 12 and older with chronic temporomandibular disorder and headaches see if the treatment reduces pain.
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Daily ear vagus‑nerve stimulation to reduce TMD jaw and facial pain
This will test whether daily, at‑home gentle electrical stimulation of the ear's vagus nerve can reduce chronic jaw and facial pain in adults with temporomandibular disorder (TMD).
-
Heat therapy for jaw pain in chronic TMD
This study tests whether applying local heat to the jaw can reduce pain and jaw fatigue in adults with chronic temporomandibular disorder during a clenching task.
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Investigating the link between levonorgestrel intrauterine system and temporomandibular disorders
This study is trying to see if using a specific birth control device called the levonorgestrel intrauterine system is linked to jaw joint problems in women.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.