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

NCT06633445 | Completed DMC

• 1 other identifier: 3D guided Botox injection
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Disc Displacement

Outcome Measures

Primary Outcomes (4)

• • Maximum interincisal opening in millimeters.

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

  6 months

• clicking

  Any noticeable sound detected temporomandibular joint during opening and closing

  6 months

• temporomandiular joint tenderness

  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

  6 months

• lateral pterygoid muscle tenderness

  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

  6 months

Study Arms (2)

3D guided botulinum toxin injection arm

EXPERIMENTAL

Procedure: botulinum toxin type A injection in lateral pterygoid muscle

Electromyography botulinum toxin injection arm

ACTIVE COMPARATOR

Procedure: botox injection in lateral pterygoid muscle

Interventions

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.

3D guided botulinum toxin injection arm

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.

Electromyography botulinum toxin injection arm

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahmoud Akram Khodir: lead

Study Sites (1)

faculty of dentistry, Alexandria university

Alexandria, 21715, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40544291 DERIVED

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of oral and maxillofacial surgery

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 9, 2024
• Study Start: November 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

EG (1)