Ultrasound-guided Botox injections into jaw muscles for condylar and subcondylar fractures

The Effectiveness of Guided Botulinum Toxin "A" Injection to the Masticatory Muscles in the Management of Condylar and Subcondylar Fractures (Randomized Controlled Clinical Trial)

This will test whether ultrasound-guided Botox injections into the chewing muscles help people with unilateral condylar or subcondylar jaw fractures treated with closed reduction and intermaxillary fixation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Alexandria University (other)
• Locations: 1 site (Alexandria)
• Trial ID: NCT07374341 on ClinicalTrials.gov

What this trial studies

This single-center interventional protocol delivers botulinum toxin A (BOTOX Cosmetic®) under ultrasound guidance into the masseter, temporalis, and lateral pterygoid muscles as an adjunct to closed reduction and intermaxillary fixation for condylar and subcondylar fractures. Eligible patients have unilateral extra‑capsular or selected intra‑capsular fractures with moderate displacement and reproducible occlusion; those with bilateral severe displacement, unstable occlusion, or contraindications to BTX are excluded. The approach aims to reduce masticatory muscle forces that can displace fracture fragments, improve pain and occlusal stability, and potentially avoid open surgical fixation. Procedures and follow-up occur at the Faculty of Dentistry, Alexandria University.

Who should consider this trial

Good fit: Ideal candidates are adults with unilateral extra‑capsular or selected intra‑capsular condylar/subcondylar fractures, moderate displacement (≤45°), reproducible occlusion, and more than half the dentition available, managed by closed reduction and intermaxillary fixation.

Not a fit: Patients with bilateral or severely displaced (>45°) condylar fractures, unstable occlusion, severe polytrauma, pregnancy or lactation, BTX allergy, active infection at injection sites, or motor neuron disease are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the technique could reduce muscle-driven fragment displacement, improve pain and occlusal outcomes, and decrease the need for open surgery in some patients.

How similar studies have performed: Botulinum toxin is used for masticatory muscle disorders and some pilot work supports its role in reducing muscle activity, but using ultrasound‑guided BTX specifically to aid closed management of condylar fractures is relatively novel with limited direct evidence.

Eligibility criteria

Inclusion Criteria:

* Having unilateral extra-capsular condylar/ sub-condylar fractures isolated or associated with other fractures.
* Isolated intra-capsular fractures.
* Moderate condylar displacement, JO to 45 degrees or incomplete fractures.
* Reproducible occlusion without drop-back or with drop-back that returns to midline on release of posterior force.
* Availability of more than half of the dentition

Exclusion Criteria:

* Bilateral condylar fractures
* Gross condylar displacement\> 45 degrees (severely displaced)
* Anatomic reduction of ramus height 2: 2 mm
* Unstable occlusion (e.g., periodontal disease, less than three teeth per quadrant)
* Patients with severe polytraumas.
* Patients with relative contraindications to BTX injections that may include; pregnancy, lactation, BTX Allergies and presence of infection at the injection site.
* Patients with motor neuron diseases.

Where this trial is running

Alexandria

• Faculty of Dentistry, Alexandria University, Egypt — Alexandria, Egypt (RECRUITING)

Study contacts

• Study coordinator: Pakinam Gheeta, BDS

Conditions: Condylar Fractures, Subcondylar Fracture