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

Not Applicable

Completed

• Conditions: Anterior Disc Displacement
• Interventions: Procedure: botox injection in lateral pterygoid muscle; Procedure: botulinum toxin type A injection in lateral pterygoid muscle

• Registration Number: NCT06633445
• Lead Sponsor: Mahmoud Akram Khodir

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-09-01
• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-08
• Study First Posted: 2024-10-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electromyography botulinum toxin injection arm	botox injection in lateral pterygoid muscle	-
3D guided botulinum toxin injection arm	botulinum toxin type A injection in lateral pterygoid muscle	-

Primary Outcome Measures

Name	Time	Method
• Maximum interincisal opening in millimeters.	6 months	measured in millimeters from incisal edge of uppercentrals to incisal edge of lower incisors by disposable rulers.
clicking	6 months	Any noticeable sound detected temporomandibular joint during opening and closing
temporomandiular joint tenderness	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
lateral pterygoid muscle tenderness	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

Trial Locations

Locations (1)

faculty of dentistry, Alexandria university; 🇪🇬 Alexandria, Egypt