The Effectiveness of Guided Botulinum Toxin "A" Injection to the Masticatory Muscles in the Management of Condylar and Subcondylar Fractures

Recruiting now · Not applicable

Conditions studied: Condylar Fractures, Subcondylar Fracture

In brief

The aim of this study, is to evaluate the effectiveness of ultrasound guided injection of botulinum toxin A into the muscles of mastication; the masseter, temporalis and the lateral pterygoid, in a closed reduction approach of condylar and sub-condylar fractures, seeking to shed light on the efficacy and potential advantages of this innovative therapeutic avenue.

Key facts

Study ID: NCT07374341
Run by: Pakinam Gheeta
People needed: 16
Starts: 2025-04-10
Expected to finish: 2026-04-01
Last updated by the study team: 2026-01-28

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Faculty of Dentistry, Alexandria University, Egypt — Alexandria, Egypt (enrolling)

Full record on ClinicalTrials.gov

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