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 )

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.

Study Overview

• Status: Completed
• Conditions: Anterior Disc Displacement
• Intervention / Treatment: Procedure: botulinum toxin type A injection in lateral pterygoid muscle; Procedure: botox injection in lateral pterygoid muscle

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21715
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D guided botulinum toxin injection arm	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.
Active Comparator: Electromyography botulinum toxin injection arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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

Collaborators and Investigators

• Sponsor: Mahmoud Akram Khodir

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Neuromuscular Agents; Acetylcholine Release Inhibitors; Botulinum Toxins, Type A; abobotulinumtoxinA; Botulinum Toxins
• Other Study ID Numbers: 3D guided Botox injection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes