NCT06633445

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Mahmoud Akram Khodir · Academic / Other
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anterior Disc Displacement

Interventions

Type	Name	Description
PROCEDURE	botulinum 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.
PROCEDURE	botox 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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-06-01
• Completion: 2024-09-01
• First posted: 2024-10-09
• Last updated: 2025-01-27

Locations

1 site across 1 country: Egypt