An interventional study of Botulinum Toxin type a (Botox) in Anterior Disc Displacement, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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.
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.
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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)
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
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.
Time frame: Baseline (preoperative), 2 weeks, 6 weeks, 12 weeks, and 24 weeks post-injection
Change in TMJ Clicking Sounds
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.
Time frame: Baseline and at 2, 6, 12, and 24 weeks.
Change in Maximum Interincisal Opening (MIO)
Maximum interincisal opening (measured in millimeters) were recorded at each follow-up.
Time frame: Baseline and at 2, 6, 12, and 24 weeks.
Change in Lateral Excursion of the Mandible
Lateral excursion (measured in millimeters) was recorded on both sides.
Time frame: Baseline and at 2, 6, 12, and 24 weeks.
Change in Disc Position on MRI
Disc position was assessed using MRI and recorded as an angular measurement (degrees) relative to the condyle.
Time frame: baseline (preintervention) and 12 weeks postintervention.
Change in Fonseca's Questionnaire Score
Fonseca's questionnaire was used to evaluate TMJ dysfunction severity on a scale from 0 to 100.
Time frame: baseline (preintervention) and 24 weeks postintervention.
Plan to share: No
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