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

M

Mahmoud Akram Khodir

Status

Completed

Conditions

Anterior Disc Displacement

Treatments

Procedure: botox injection in lateral pterygoid muscle
Procedure: botulinum toxin type A injection in lateral pterygoid muscle

Study type

Interventional

Funder types

Other

Identifiers

NCT06633445
3D guided Botox injection

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

3D guided botulinum toxin injection arm
Experimental group
Treatment:
Procedure: botulinum toxin type A injection in lateral pterygoid muscle
Electromyography botulinum toxin injection arm
Active Comparator group
Treatment:
Procedure: botox injection in lateral pterygoid muscle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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