Ultrasound-Guided Botulinum Toxin A Injection for TMJ Disc Displacement With Reduction

NCT07076355 | Completed

• 1 other identifier: OS-3-24-2126
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial was designed to evaluate the effectiveness of ultrasonography-guided botulinum toxin type A (BTX-A) injection into the lateral pterygoid muscle for the management of temporomandibular joint (TMJ) anterior disc displacement with reduction (ADDwR). Ten patients diagnosed with ADDwR participated in the study. Each patient received an ultrasound-guided injection of 25 units of BTX-A into the lateral pterygoid muscle under local anesthesia. Clinical evaluations were performed preoperatively and at 2, 6, 12, and 24 weeks postoperatively. Outcome measures included pain levels assessed by the Numerical Rating Scale (NRS), TMJ sounds (clicking) detected using a stethoscope, disc position assessed by MRI, mandibular function parameters such as lateral excursion and maximum interincisal opening, and the Fonseca's questionnaire scores. The results demonstrated a significant reduction in pain and TMJ sounds, improvement in disc position, and enhanced mandibular function over a 6-month follow-up period. These findings suggest that ultrasonography-guided BTX-A injection into the lateral pterygoid muscle is a safe and effective treatment option for patients with TMJ ADDwR.

Conditions

Anterior Disc Displacement

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity on the Numerical Pain Rating Scale (NPRS)

  The Numerical Pain Rating Scale (0-10) was used to assess changes in pain intensity from baseline to follow-up time frames, with higher scores indicating greater pain.

  Baseline (preoperative), 2 weeks, 6 weeks, 12 weeks, and 24 weeks post-injection

Secondary Outcomes (5)

• Change in TMJ Clicking Sounds

  Baseline and at 2, 6, 12, and 24 weeks.

• Change in Maximum Interincisal Opening (MIO)

  Baseline and at 2, 6, 12, and 24 weeks.

• Change in Lateral Excursion of the Mandible

  Baseline and at 2, 6, 12, and 24 weeks.

• Change in Disc Position on MRI

  baseline (preintervention) and 12 weeks postintervention.

• Change in Fonseca's Questionnaire Score

  baseline (preintervention) and 24 weeks postintervention.

Study Arms (1)

Ultrasound-Guided Botulinum Toxin Type A Injection

EXPERIMENTAL

Patients in this arm received an ultrasound-guided injection of botulinum toxin type A (BTX-A) into the lateral pterygoid muscle to treat temporomandibular joint anterior disc displacement with reduction (ADDwR). The procedure was performed under local anesthesia with real-time ultrasonographic visualization to ensure accurate delivery and minimize complications.

Drug: Botulinum Toxin type a (Botox)

Interventions

Botulinum Toxin type a (Botox) DRUG

A single dose of 25 units of botulinum toxin type A (BTX-A) was injected into the lateral pterygoid muscle using ultrasonography-guided technique. The injection was performed under local anesthesia with patient monitoring.

Also known as: BTX-A

Ultrasound-Guided Botulinum Toxin Type A Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with bilateral anterior disc displacement with reduction (ADDwR) using Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
• Patients aged 18 years or older.
• Patients who did not respond to previous conservative treatments.

You may not qualify if:

• Known allergy to any components of botulinum toxin type A (BTX-A).
• Presence of temporomandibular joint (TMJ) hypermobility.
• History of TMJ surgery.
• Presence of any significant pathology around the TMJ.
• Pregnant women.
• Individuals with systemic diseases that may affect the TMJ or the procedure.
• Patients with blood coagulopathy.
• Patients with unilateral ADDwR.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

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 Officials

• Rosie A Othman

  Tanta University

  PRINCIPAL INVESTIGATOR

• Ibrahim M Nowair

  Faculty of Dentistry, Tanta University, Egypt

  PRINCIPAL INVESTIGATOR

• Ahmed G Abushahba

  Faculty of Dentistry, Tanta University, Egypt

  PRINCIPAL INVESTIGATOR

• Mohamed S Abdelghany Elbrol

  Faculty of Medicine, Tanta University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 22, 2025
• Study Start: May 23, 2024
• Primary Completion: December 26, 2024
• Study Completion: December 26, 2024
• Last Updated: August 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)