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

NCT07374341 | Recruiting

• 1 other identifier: 9239261
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (7)

• 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: 1. Same to pre-traumatic 2. Minor difference 3. Functional malocclusion 4. Needs occlusal correction 5. 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

Study Arms (2)

Ultrasound-guided Botulinum Toxin injection + closed reduction and intermaxillary fixation

EXPERIMENTAL

Other: BOTOX Cosmetic®; Procedure: Closed reduction and intermaxillary fixation

Conventional treatment

ACTIVE COMPARATOR

Procedure: Closed reduction and intermaxillary fixation

Interventions

BOTOX Cosmetic® OTHER

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.

Ultrasound-guided Botulinum Toxin injection + closed reduction and intermaxillary fixation

Closed reduction and intermaxillary fixation PROCEDURE

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.

Conventional treatment; Ultrasound-guided Botulinum Toxin injection + closed reduction and intermaxillary fixation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakinam Gheeta: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Pakinam Gheeta, BDS

CONTACT

+20 11 15568102; p.sameeh150115@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor of oral surgery

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 28, 2026
• Study Start: April 10, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)