Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A
Status:
Not yet recruiting
Trial end date:
2025-08-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to investigate the effect of botulinum toxin on neurons'
plasticity in the masseter muscle in humans with and without painful myogenous
temporomandibular disorders (TMDM). The main questions it aims to answer are:
- does treatment with botulinum toxin alter gene expressions, epigenetic signatures, and
cells plasticity in the masseter muscles of TMDM patients?
- do any such changes differ between patients with local and regional TMDM?
- does treatment with botulinum toxin influence pain characteristics (intensity,
frequency, and sensibility) and other variables in patients with TMDM and are there
correlations between significantly changed expression of biomarkers and other variables?
Participants will be examined with a questionnaire, clinical examination, and biopsy
sampling from one of the masseter and are then randomized to treatment with botulinum
toxin or control (isotonic saline). Follow-ups occur after one, three, and six months
with questionnaire, clinical examination, and collection of post-treatment microbiopsies
to see if botulinum toxin alter peripheral molecular events and clinical variables.
Phase:
Phase 2
Details
Lead Sponsor:
Karolinska Institutet
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A