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Completed

NCT Number: NCT06633445

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

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.

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Key information

Conditions

Anterior Disc Displacement

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry, Alexandria university

Alexandria, 21715, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

botulinum toxin type A injection in lateral pterygoid muscle

Procedure
  • 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

Procedure
  • 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.

Primary outcomes

  1. • Maximum interincisal opening in millimeters.

    Time frame: 6 months

    measured in millimeters from incisal edge of uppercentrals to incisal edge of lower incisors by disposable rulers.

  2. clicking

    Time frame: 6 months

    Any noticeable sound detected temporomandibular joint during opening and closing

  3. temporomandiular joint tenderness

    Time frame: 6 months

    using 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

  4. lateral pterygoid muscle tenderness

    Time frame: 6 months

    using 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

Sponsors and collaborators

Lead sponsor

Mahmoud Akram Khodir

Other

Registry information

Official study title

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 )

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 9, 2024
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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