The Effectiveness of Guided Botulinum Toxin "A" Injection to the Masticatory Muscles in the Management of 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)

Overview

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.

Interventions

• Other BOTOX Cosmetic®
  The BTX vile is diluted with 2.0 cc saline or distilled water. It is 5 BU (Botox) per 0.1cc, so it is easy to measure (for 2.5 cc normal saline, you can calculate as 4 BU per 0.1 cc) therefore, the investigators can easily adjust the amount to be injected into the muscles of Mastication. Using a 5 cc syringe, draw more than 3 cc of air and inject into the botulinum toxin vial. Check whether the air is sucked into the vial. If air is not sucked into the vial, the vial is discarded as the vacuum i
• Procedure Closed reduction and intermaxillary fixation
  All patients will be treated using the closed reduction and intermaxillary fixation method. The patients will be treated under local or general anesthesia depending on the availability of other concomitant fractures and general status of the patient.

Primary outcome measures

• Postoperative pain [Time frame: up to 2 weeks]
• Occlusion Assessment [Time frame: up to 3 months]
• Mouth opening [Time frame: up to 3 months]
• Mouth deviation assessment [Time frame: up to 3 months]
• Time frame needed until the intermaxillary fixation (IMF) is removed [Time frame: through study completion, an average of 6 months]
• Bone density at the fracture line [Time frame: 6 months]
• The angle between fracture and the longitudinal axis of the ramus [Time frame: 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Dentistry, Alexandria University, Egypt — Alexandria

Identifiers

NCT: NCT07374341 · 9239261

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗