Injecting Lateral Pterygoid Muscle by Botulinum Toxin Type A With 2 Different Methods : 3D Guided Appliance and Electromyography (EMG) .
NCT ID: NCT06633445
Last Updated: 2025-01-27
Study Results
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Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2023-11-01
2024-09-01
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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3D guided botulinum toxin injection arm
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.
Electromyography botulinum toxin injection arm
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Their age range between 20 and 45 years.
3. Angle class I maxilla-mandibular relation.
Exclusion Criteria
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
20 Years
45 Years
ALL
No
Sponsors
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Mahmoud Akram Khodir
OTHER
Responsible Party
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Mahmoud Akram Khodir
Assistant Lecturer of oral and maxillofacial surgery
Locations
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faculty of dentistry, Alexandria university
Alexandria, , Egypt
Countries
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References
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Raafa N, Melek L, Zoheir H, Mansour E, Sakr A. A novel fully guided technique for botulinum toxin injection in lateral pterygoid muscle using muscle segmentation for TMJ disc displacement with reduction: a randomized controlled trial. BMC Oral Health. 2025 Jun 21;25(1):957. doi: 10.1186/s12903-025-06372-w.
Other Identifiers
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3D guided Botox injection
Identifier Type: -
Identifier Source: org_study_id
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