Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
NCT07374341

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

Led by Pakinam Gheeta · Updated on 2026-01-28

16

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Having unilateral extra-capsular condylar or sub-condylar fractures, isolated or with other fractures
  • Isolated intra-capsular fractures
  • Moderate condylar displacement, 10 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
Not Eligible

You will not qualify if you...

  • Bilateral condylar fractures
  • Gross condylar displacement greater than 45 degrees (severely displaced)
  • Anatomic reduction of ramus height greater than 2 mm
  • Unstable occlusion, such as periodontal disease or fewer than three teeth per quadrant
  • Severe polytrauma
  • Pregnancy or lactation
  • Allergies to botulinum toxin or infection at the injection site
  • Motor neuron diseases

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Actively Recruiting

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Research Team

P

Pakinam Gheeta, BDS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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