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

NCT07374341 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-01-28

No results posted yet for this study

Summary

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

  • Condylar Fractures
  • Subcondylar Fracture

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 is not present in the vial, thus it is faulty. To achieve a desirable concentration of dilution solution, an injection of 2.5 cc of normal saline into botulinum toxin and then it is gently mixed. Two to Three days prior to the surgical intervention, the BTX will be injected to the muscles of mastication; the lateral pterygoid, the masseter and temporal is of the fractured site. The, closed reduction and intermaxillary fixation will be performed for fracture management.

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.

Sponsors & Collaborators

  • Pakinam Gheeta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07374341 on ClinicalTrials.gov