ClinicalTrials.gg
Not yet recruitingNCT07774884Updated Aug 19, 2026

Does Addition of Medial Pterygoid Muscle Injection Improve the Outcome of Botulinum Toxin Therapy for Masticatory Myofascial Pain Syndrome?

An interventional study of conventional BoNT-A treatment and Placebo in Masticatory Myofascial Pain Syndrome, sponsored by Fayoum University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Fayoum University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

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.

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Conditions studied

  • Masticatory Myofascial Pain Syndrome

Keywords

  • Masticatory myofascial pain syndrome
  • masseter muscle
  • Temporalis muscle
  • medial pterygoid
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In context

Myofascial Pain Syndromes

339 studies on the registry are indexed under Myofascial Pain Syndromes; 66 are open to participants now.

This study's planned enrollment of 111 is above the median of 50 across 307 interventional studies indexed under Myofascial Pain Syndromes.

Browse Myofascial Pain Syndromes studies →

Lead sponsor

Fayoum University is the lead sponsor of 148 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 .
  • Known to the study medication or formulation components.
  • Local infection at the injection site.
  • Significant bleeding disorder.
  • uncontrolled anticoagulation.
  • Previous major surgery involving the medial pterygoid region that could alter anatomy.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
111 participants (estimated)

Study arms

  • Active comparator
    Group A

    botulinum toxin type A injection into the bilateral masseter and temporalis muscles

    Procedure: conventional BoNT-A treatment

  • Experimental
    Group B

    masseter and temporalis injections , in addition to targeted injection of the clinically involved medial pterygoid muscle

    Procedure: conventional treatment plus medial pterygoid injection

  • Placebo comparator
    Group C

    predefined placebo/sham injection protocol

    Procedure: Placebo

Interventions

  • Procedureconventional BoNT-A treatment

    botulinum toxin type A injection into the bilateral masseter and temporalis muscles

  • ProcedurePlacebo

    placebo/sham injection protocol

  • Procedureconventional treatment plus medial pterygoid injection

    masseter and temporalis injections as Group A, in addition to targeted injection of the clinically involved medial pterygoid muscle

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What researchers measure

Primary outcomes

  1. pain intensity

    a 10-point visual analogue scale (VAS), where 0 revealed no pain and 10 represented the worst imaginable pain

    Time frame: 6 months

07

Study locations

1 site
  • MUST University
    Cairo, Cairo Governorate 21523, Egypt
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References and documents

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 38151884 ↗
  • Yoshida 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07774884
Lead sponsor
Fayoum University
Responsible party
Alshaimaa Ahmed shabaan (Prof., Fayoum University) — Principal investigator
First posted
Aug 19, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Mar 1, 2027 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Aug 19, 2026

Study contacts

Alshaimaa Mohamed, PhD
Contact
aas16@fayoum.edu.eg
00201006047940
Islam Kassem, PhD
Contact
ikassem@dr.com
Alshaimaa Mohamed
principal investigator · Fayoum University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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