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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07076355
Enrollment
10
Registered
2025-07-22
Start date
2024-05-23
Completion date
2024-12-26
Last updated
2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Disc Displacement

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.

Detailed description

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.

Interventions

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.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Intensity on the Numerical Pain Rating Scale (NPRS)Baseline (preoperative), 2 weeks, 6 weeks, 12 weeks, and 24 weeks post-injectionThe 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

MeasureTime frameDescription
Change in TMJ Clicking SoundsBaseline 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.
Change in Maximum Interincisal Opening (MIO)Baseline and at 2, 6, 12, and 24 weeks.Maximum interincisal opening (measured in millimeters) were recorded at each follow-up.
Change in Lateral Excursion of the MandibleBaseline and at 2, 6, 12, and 24 weeks.Lateral excursion (measured in millimeters) was recorded on both sides.
Change in Disc Position on MRIbaseline (preintervention) and 12 weeks postintervention.Disc position was assessed using MRI and recorded as an angular measurement (degrees) relative to the condyle.
Change in Fonseca's Questionnaire Scorebaseline (preintervention) and 24 weeks postintervention.Fonseca's questionnaire was used to evaluate TMJ dysfunction severity on a scale from 0 to 100.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026