Recruiting

NCT Number: NCT07374341

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

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.

Recruiting

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Key information

Conditions

Condylar Fractures Subcondylar Fracture

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Location status: Recruiting

Location contact

Pakinam Gheeta, BDS

CONTACT

[email protected]

+20 11 15568102

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

Postoperative pain

Time frame: up to 2 weeks

Will be assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Occlusion Assessment

Time frame: up to 3 months
Assessment of the Occlusion will be performed and given a score:
- Same to pre-traumatic
- Minor difference
- Functional malocclusion
- Needs occlusal correction
- Gross malocclusion.
Mouth opening

Time frame: up to 3 months

Inter-incisal distance will be measured in (cm) using a ruler, to assess the degree of mouth opening.
Mouth deviation assessment

Time frame: up to 3 months

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.
Time frame needed until the intermaxillary fixation (IMF) is removed

Time frame: through study completion, an average of 6 months

The Intermaxillary fixation will be removed once satisfactory occlusion was achieved and time frame of the IMF will be recorded for each patient.
Bone density at the fracture line

Time frame: 6 months

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.
The angle between fracture and the longitudinal axis of the ramus

Time frame: 6 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pakinam Gheeta, BDS

CONTACT

[email protected]

+20 11 15568102

Sponsors and collaborators

Lead sponsor

Pakinam Gheeta

Other

Registry information

Official study 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)

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 28, 2026
Registry last updated: Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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