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Completed

NCT Number: NCT07076355

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

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.

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Key information

Conditions

Anterior Disc Displacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

About this study

This study investigated the therapeutic potential of ultrasonography-guided botulinum toxin type A (BTX-A) injection into the lateral pterygoid muscle in patients diagnosed with temporomandibular joint (TMJ) anterior disc displacement with reduction (ADDwR). The intervention was performed under local anesthesia with patient monitoring. High-frequency ultrasonography was utilized to accurately identify the lateral pterygoid muscle and guide the injection to minimize risks to adjacent anatomical structures.

The study followed patients over a 6-month period to assess changes in TMJ-related pain, functional parameters, and disc position. Pain intensity was measured using the Numerical Pain Rating Scale (NPRS), joint sounds were assessed clinically and with a stethoscope, disc position was evaluated via MRI, and mandibular movements were assessed by measuring lateral excursion and maximum interincisal opening. Patient-reported outcomes were also evaluated using the Fonseca's questionnaire.

The findings demonstrated a significant reduction in TMJ pain and joint noises, as well as improved mandibular function and disc alignment during the follow-up period. No major complications were observed, supporting the safety and efficacy of ultrasound-guided BTX-A injections in managing ADDwR.

This research provides clinical evidence for a minimally invasive and precise technique to manage TMJ internal derangements and reduce the impact of hyperactive lateral pterygoid muscle activity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: BTX-A

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Change in TMJ Clicking Sounds

    Time frame: Baseline and at 2, 6, 12, and 24 weeks.

    Joint sounds were assessed using a stethoscope and scored as absent, heard only with a stethoscope, or heard unaided. We also quantified the intensity of the clicking sound using a custom made digital stethoscope to measure the sound in decibel units.

  2. Change in Maximum Interincisal Opening (MIO)

    Time frame: Baseline and at 2, 6, 12, and 24 weeks.

    Maximum interincisal opening (measured in millimeters) were recorded at each follow-up.

  3. Change in Lateral Excursion of the Mandible

    Time frame: Baseline and at 2, 6, 12, and 24 weeks.

    Lateral excursion (measured in millimeters) was recorded on both sides.

  4. Change in Disc Position on MRI

    Time frame: baseline (preintervention) and 12 weeks postintervention.

    Disc position was assessed using MRI and recorded as an angular measurement (degrees) relative to the condyle.

  5. Change in Fonseca's Questionnaire Score

    Time frame: baseline (preintervention) and 24 weeks postintervention.

    Fonseca's questionnaire was used to evaluate TMJ dysfunction severity on a scale from 0 to 100.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Evaluation of the Ultrasonography-Guidance for Botulinum Toxin Type A Injection Into Lateral Pterygoid Muscle in Patients With TMJ Anterior Disc Displacement With Reduction

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2025
Registry last updated
Aug 12, 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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