Investigating the effects of botulinum toxin on jaw pain mechanisms
Official title: Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A. A Randomized, Controlled, Double-blind Study
Run by Karolinska Institutet · NCT05720065 · Data updated 2026-11-12
This study is testing if botulinum toxin can help reduce jaw pain by looking at how it affects the muscles and nerves in people with and without jaw disorders.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years to 45 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Huddinge, Stockholm County) |
| Status | Recruiting |
| Started | November 14, 2023 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT05720065 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are females diagnosed with myalgia or myofascial pain related to TMDM, experiencing significant pain upon palpation of the masseter muscle.
✕Probably not a fit
Patients with systemic inflammatory diseases, widespread pain, or those who have recently received botulinum toxin treatment 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 clinical trial aims to explore how botulinum toxin affects neuronal plasticity in the masseter muscle of individuals with and without painful temporomandibular disorders (TMDM). Participants will undergo a thorough assessment, including questionnaires, clinical examinations, and biopsies, before being randomly assigned to receive either botulinum toxin or a saline placebo. The study will evaluate changes in gene expression, pain characteristics, and other relevant biomarkers to determine the treatment's efficacy. The trial is conducted at the University Dental Clinic, Karolinska Institutet in Sweden.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief from pain and improve quality of life for patients suffering from temporomandibular disorders.
How similar studies have gone: Previous studies have shown promising results with botulinum toxin for treating various pain conditions, suggesting potential success for this approach in TMDM.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * a diagnosis of TMDM myalgia or myofascial pain according to the DC/TMD criteria * females with adequate contraceptives and a negative pregnancy test * pain upon digital palpation of at least one of the masseter muscle * a characteristic pain intensity of \> 40/100 * a negative pregnancy test at the day of treatment Exclusion Criteria: * difficulties understanding the Swedish language * systemic inflammatory connective tissue diseases * widespread pain * neuromuscular disorders * diagnosed or severe psychiatric disease * neuropathic pain * pain of dental origin * history of trauma to the face, head or neck * pregnancy or nursing * known allergy to botulinum toxin or antibiotics * use of muscle relaxants, antidepressant, neuropsychiatric, anticoagulant drugs, or aminoglycoside antibiotics * previous treatment with botulinum toxin during the last 12 months * use of analgesic or anti-inflammatory medication during the 48 hours preceding biopsy * skin infection over injection/biopsy site
Where it's running
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Department of Dental Medicine, Karolinska Institutet
Huddinge, Stockholm County, Sweden Recruiting
Study contacts
- Principal investigator: Malin Ernberg — Karolinska Institutet
- Study coordinator: Malin Ernberg, PhD
- Email: malin.ernberg@ki.se
- Phone: +46706368236
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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.