The Effectiveness of Guided Botulinum Toxin "A" Injection to the Masticatory Muscles in the Management of Condylar and Subcondylar Fractures (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Ultrasound-guided Botulinum Toxin injection + closed reduction and intermaxillary fixation
干预措施: BOTOX Cosmetic® (Other)
Ultrasound-guided Botulinum Toxin injection + closed reduction and intermaxillary fixation
干预措施: Closed reduction and intermaxillary fixation (Procedure)
Conventional treatment
干预措施: Closed reduction and intermaxillary fixation (Procedure)
结局指标
主要结局
Postoperative pain
时间窗: 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
时间窗: up to 3 months
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.
Mouth opening
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Pakinam Gheeta
Instructor of oral surgery
Alexandria University