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

Pakinam Gheeta

Status

Enrolling

Conditions

Condylar Fractures

Subcondylar Fracture

Treatments

Other: BOTOX Cosmetic®

Procedure: Closed reduction and intermaxillary fixation

Study type

Interventional

Funder types

Other

Identifiers

NCT07374341

9239261

Details and patient eligibility

About

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.

Enrollment

16 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.