Ultrasound-guided Botox injections into jaw muscles for condylar and subcondylar fractures
Official title: The Effectiveness of Guided Botulinum Toxin "A" Injection to the Masticatory Muscles in the Management of Condylar and Subcondylar Fractures (Randomized Controlled Clinical Trial)
Run by Alexandria University · NCT07374341 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Status | Recruiting |
| Started | April 10, 2025 |
| Main results expected | April 2026 |
| Study ends | April 2026 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT07374341 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Egypt Recruiting
Study contacts
- Study coordinator: Pakinam Gheeta, BDS
- Email: p.sameeh150115@alexu.edu.eg
- Phone: +20 11 15568102
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.