Masticatory Myofascial Pain SyndromeNCT07774884
Does Addition of Medial Pterygoid Muscle Injection Improve the Outcome of Botulinum Toxin Therapy for Masticatory Myofascial Pain Syndrome?
A study testing conventional BoNT-A treatment and conventional treatment plus medial pterygoid injection in people with Masticatory Myofascial Pain Syndrome, run by Fayoum University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Masticatory Myofascial Pain Syndrome
- What is being tested?
- conventional BoNT-A treatment and conventional treatment plus medial pterygoid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Islam Kassem, PhD contact
Egypt1 site
MUST University
Cairo, Cairo Governorate, 21523
Alshaimaa shabaan, 01006047940, aas16@fayoum.edu.eg
About this study
Official title: Does Addition of Medial Pterygoid Muscle Injection Improve the Outcome of Botulinum Toxin Therapy for Masticatory Myofascial Pain Syndrome? A Randomized Controlled Clinical Trial
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.
Read the detailed description
Current evidence supports the efficacy of BoNT-A in reducing pain and improving mandibular function in patients with localized MMPS. However, the specific contribution of targeted medial pterygoid injection to overall treatment outcomes remains unclear. This study aims to address this gap by evaluating whether the addition of targeted medial pterygoid injection enhances the clinical efficacy of conventional masseter and temporalis BoNT-A therapy.
- Conditions
- Masticatory Myofascial Pain Syndrome
- Being tested
- conventional BoNT-A treatment, Placebo, conventional treatment plus medial pterygoid injection
- Keywords
- Masticatory myofascial pain syndrome, masseter muscle, Temporalis muscle, medial pterygoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional BoNT-A treatmentProcedure or surgery
botulinum toxin type A injection into the bilateral masseter and temporalis muscles
PlaceboProcedure or surgery
placebo/sham injection protocol
conventional treatment plus medial pterygoid injectionProcedure or surgery
masseter and temporalis injections as Group A, in addition to targeted injection of the clinically involved medial pterygoid muscle
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | botulinum toxin type A injection into the bilateral masseter and temporalis muscles Receives: Procedure: conventional BoNT-A treatment |
| Group B | Experimental | masseter and temporalis injections , in addition to targeted injection of the clinically involved medial pterygoid muscle Receives: Procedure: conventional treatment plus medial pterygoid injection |
| Group C | Placebo comparator | predefined placebo/sham injection protocol Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
a 10-point visual analogue scale (VAS), where 0 revealed no pain and 10 represented the worst imaginable pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Masticatory Myofascial Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaimaa Ahmed shabaan, Fayoum University
- Investigators
- Alshaimaa Mohamed, Principal investigator, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774884
- Sponsor's protocol ID
- MP injection Botox
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li K, Tan K, Yacovelli A, Bi WG. Effect of botulinum toxin type A on muscular temporomandibular disorder: A systematic review and meta-analysis of randomized controlled trials. J Oral Rehabil. 2024 May;51(5):886-897. doi: 10.1111/joor.13648. Epub 2023 Dec 27.
PubMed 38151884Yoshida K. Botulinum Toxin Therapy for Oromandibular Dystonia and Other Movement Disorders in the Stomatognathic System. Toxins (Basel). 2022 Apr 14;14(4):282. doi: 10.3390/toxins14040282.
PubMed 35448891