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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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 i
• Процедура 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.

Первичные конечные точки

• Postoperative pain [Срок оценки: up to 2 weeks]
• Occlusion Assessment [Срок оценки: up to 3 months]
• Mouth opening [Срок оценки: up to 3 months]
• Mouth deviation assessment [Срок оценки: up to 3 months]
• Time frame needed until the intermaxillary fixation (IMF) is removed [Срок оценки: through study completion, an average of 6 months]
• Bone density at the fracture line [Срок оценки: 6 months]
• The angle between fracture and the longitudinal axis of the ramus [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Dentistry, Alexandria University, Egypt — Alexandria

Идентификаторы

NCT: NCT07374341 · 9239261

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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