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

The Effectiveness of Guided Botulinum Toxin "A" Injection to the Masticatory Muscles in the Management of Condylar and Subcondylar Fractures (Randomized Controlled Clinical Trial)

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.

Study Overview

• Status: Recruiting
• Conditions: Condylar Fractures; Subcondylar Fracture
• Intervention / Treatment: Other: BOTOX Cosmetic®; Procedure: Closed reduction and intermaxillary fixation

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pakinam Gheeta, BDS; Phone Number: +20 11 15568102; Email: p.sameeh150115@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Faculty of Dentistry, Alexandria University, Egypt
    • Contact: Pakinam Gheeta, BDS; Phone Number: +20 11 15568102; Email: p.sameeh150115@alexu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional treatment	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.
Experimental: Ultrasound-guided Botulinum Toxin injection + closed reduction and intermaxillary fixation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Will be assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)	up to 2 weeks
Occlusion Assessment	Assessment of the Occlusion will be performed and given a score: Same to pre-traumatic; Minor difference; Functional malocclusion; Needs occlusal correction; Gross malocclusion.	up to 3 months
Mouth opening	Inter-incisal distance will be measured in (cm) using a ruler, to assess the degree of mouth opening.	up to 3 months
Mouth deviation assessment	The status of the deviation preoperatively, for the example the availability of cross bites or minor deviations, will be compared to the statues three months postoperatively. Photographs will be obtained for all patients to document occlusion and mouth opening.	up to 3 months
Time frame needed until the intermaxillary fixation (IMF) is removed	The Intermaxillary fixation will be removed once satisfactory occlusion was achieved and time frame of the IMF will be recorded for each patient.	through study completion, an average of 6 months
Bone density at the fracture line	An immediate postoperative CT will be obtained, followed by another one taken after 6 months postoperatively. The mean bone density at the fracture line in the 6 months CT-scan will be compared with the immediate postoperative and the preoperative scans and the mean difference between the scans will be calculated.	6 months
The angle between fracture and the longitudinal axis of the ramus	An immediate postoperative CT will be obtained, followed by another one taken after 6 months postoperatively. The angle between the condylar or subcondylar fracture, and the longitudinal axis of the ramus will be measured and compared pre-operatively and six months post operatively and the difference will be calculated.	6 months

Collaborators and Investigators

• Sponsor: Pakinam Gheeta

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 18, 2026
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A
• Other Study ID Numbers: 9239261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No