Does Addition of Medial Pterygoid Muscle Injection Improve the Outcome of Botulinum Toxin Therapy for Masticatory Myofascial Pain Syndrome? A Randomized Controlled Clinical Trial
| Registry | NCT07774884 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 111 (Estimated) |
| Sponsor | Fayoum University (Other) |
| Conditions | Masticatory Myofascial Pain Syndrome |
| Interventions | conventional BoNT-A treatment, Placebo, conventional treatment plus medial pterygoid injection (Procedure) |
| Dates | start 2026-09-01 (estimated), primary completion 2027-03-01 (estimated), completion 2027-05-01 (estimated), first posted 2026-08-19, last updated 2026-08-19 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Masticatory Myofascial Pain Syndrome All trials of conventional BoNT-A treatment All trials of Placebo
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A | Active comparator | Procedure: conventional BoNT-A treatment | botulinum toxin type A injection into the bilateral masseter and temporalis muscles |
| Group B | Experimental | Procedure: conventional treatment plus medial pterygoid injection | masseter and temporalis injections , in addition to targeted injection of the clinically involved medial pterygoid muscle |
| Group C | Placebo comparator | Procedure: Placebo | predefined placebo/sham injection protocol |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| MUST University | Cairo, Cairo Governorate | Egypt |