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Injecting Lateral Pterygoid Muscle by Botulinum Toxin Type A With 2 Different Methods : 3D Guided Appliance and Electromyography (EMG) .

Evaluation of 3D Guided Botulinum Toxin Type A Injection in Lateral Pterygoid Muscle for Management of Patients With Anterior Disc Displacement With Reduction ( a Randomized Controlled Clinical Trial )

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06633445
Enrollment
20
Registered
2024-10-09
Start date
2023-11-01
Completion date
2024-09-01
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Disc Displacement

Brief summary

The goal of this study is to evaluate intra-oral botulinum toxin type A injection into lateral pterygoid muscle using a surgical guide synthesized by virtual planning based on CT with soft tissue window. * To evaluate improvement of maximum interincisal opening (MIO) before and after injection. * To assess change in disc position before and after injection. * To evaluate recovery of symptoms as clicking, tenderness of TMJ and tenderness of lateral pterygoid muscle after injection. Researchers will compare intra-oral botulinum toxin type A injection using a surgical guide synthesized by virtual planning based on CT with soft tissue window to conventional EMG guided botulinum toxin injection into lateral pterygoid muscle in patient with anterior disc displacement with reduction. Participants will be injected with botulinum toxin type A by intraoral approach.

Interventions

PROCEDUREbotulinum toxin type A injection in lateral pterygoid muscle

* Needle insertion guide will be placed on upper teeth. * Needle will be inserted from needle insertion sleeve and 25-30 units of botulinum toxin type A will be injected. * Aspiration will be done before injection, and then, the patient will be asked to manipulate the mandible to activate the lateral pterygoid muscle.

PROCEDUREbotox injection in lateral pterygoid muscle

* A 27- gauge needle electrode will be inserted lateral to the maxillary tuberosity, just above the maxillary molars to inject 25-30 units of botulinum toxin type A under electromyographic guidance. * Aspiration will be done before injection, and then the patient will be asked to manipulate the mandible to activate the lateral pterygoid muscle. * The intramuscular injection will be confirmed when the electromyographic device produces a distinct loud sound.

Sponsors

Mahmoud Akram Khodir
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

1. Patients of both sexes that are diagnosed with ADDWR according to DC/TMD. 2. Their age range between 20 and 45 years. 3. Angle class I maxilla-mandibular relation.

Exclusion criteria

1. Patients with degenerative joint disease, musculoskeletal, neuromuscular disorders, cardiovascular, bleeding disorders, breathing difficulties, neurological disorders. 2. Pregnancy and lactating women. 3. History of surgical TMJ intervention. 4. Botox hypersensitivity 5. History of tumors or maxillofacial trauma. 6. Posteriorly edentulous saddles or anterior open bite. 7. Patient contraindicated to MRI examination

Design outcomes

Primary

MeasureTime frameDescription
• Maximum interincisal opening in millimeters.6 monthsmeasured in millimeters from incisal edge of uppercentrals to incisal edge of lower incisors by disposable rulers.
clicking6 monthsAny noticeable sound detected temporomandibular joint during opening and closing
temporomandiular joint tenderness6 monthsusing visual analogue scale to measure pain intensity diagrammed in a line with two ends representing 0 ( no pain) and 10 ( the worst pain) after lateral and auriculotemporal palpation of temporomandibular joint
lateral pterygoid muscle tenderness6 monthsusing visual analogue scale to measure pain intensity diagrammed in a line with two ends representing 0 ( no pain) and 10 ( the worst pain) after intraoral palpation of lateral pterygoid muscle behind tuberosity

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026