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New treatment option for Temporomandibular Disorders
Official title Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A
ClinicalTrials.gov ID: NCT05720065
What this study is testing
What is Botulinum toxin type A?
Botulinum toxin type A is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for temporomandibular disorders.
Also referred to as Botox®️ (100 U, AbbVie AB, Solna, Sweden).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 45, women only
You may be able to join if
- 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
You likely can't join if
- difficulties understanding the Swedish language
- systemic inflammatory connective tissue diseases
- widespread pain
- neuromuscular disorders
- diagnosed or severe psychiatric disease
- neuropathic pain
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Huddinge, Stockholm County, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huddinge, Stockholm County, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.