conventional BoNT-A treatmentPlaceboconventional treatment plus medial pterygoid injection
conventional BoNT-A treatment: botulinum toxin type A injection into the bilateral masseter and temporalis muscles
Placebo: placebo/sham injection protocol
conventional treatment plus medial pterygoid injection: masseter and temporalis injections as Group A, in addition to targeted injection of the clinically involved medial pterygoid muscle
Study summary
Masticatory myofascial pain syndrome (MMPS) is a common and debilitating orofacial pain condition characterized by localized or referred pain originating from trigger points in the masticatory muscles. The condition significantly impairs quality of life, affecting mastication, speech, and psychosocial well-being. The masseter and temporalis muscles are the most frequently targeted muscles in conventional botulinum toxin type A (BoNT-A) therapy for MMPS; however, the medial pterygoid muscle, a primary jaw-closing muscle, is often overlooked due to its deep anatomical location and the technical challenges associated with its injection.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Diagnosis of myogenous TMD/myalgia according to DC/TMD.
* Pain modified by jaw movement, function, or parafunction.
* Familiar pain reproduced during standardized masseter/temporalis examination.
* Clinical evidence of medial pterygoid involvement.
* Medial pterygoid provocation reproduces the patient's familiar pain.
* Symptoms present for at least 3 months.
* No major competing odontogenic cause for the patient's pain.
Exclusion Criteria:
* Predominantly arthrogenous TMD.
* Trigeminal neuralgia or other neuropathic facial pain.
* Active systemic inflammatory or infectious disease affecting the masticatory muscles.
* Significant neuromuscular disease.
* Pregnancy or breastfeeding.
* Previous BoNT-A injection into the relevant masticatory muscles during the predefined washout period.
* Known hypersensitivity to the study medication or formulation components.
* Local infection at the injection site.
* Significant bleeding disorder.
* Clinically significant uncontrolled anticoagulation.
* Previous major surgery involving the medial pterygoid region that could alter anatomy.
Primary outcome measure(s)
pain intensity — 6 months a 10-point visual analogue scale (VAS), where 0 revealed no pain and 10 represented the worst imaginable pain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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