Assessment of Mental Nerve Integrity During Fixation of Fractures at Anterior Transition Zone Using Three Different Miniplates Configurations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Sensory nerve function
研究概览
简要总结
Fractures involving the anterior transition zone of the mandible are frequently encountered and hold particular clinical significance due to the presence of the mental nerve. Consequently, mental nerve paresthesia is among the common postoperative complications associated with these fractures. To assess the mental nerve functional integrity during fixation of fractures at the anterior transition zone using twin fork-miniplate, 3d interlocking miniplate and two miniplates
详细描述
A total of 36 patients (they were divided into three groups 16 patients in each group ) with parasymphyseal-body fractures , one group was treated with twin-fork miniplate , the second group was treated using 3d interlocking miniplate and the third one was treated with conventional two miniplates. Postoperative evaluation of the mental nerve was conducted using both subjective and objective methods at intervals of 24 hours, and at 1, 4, 6 and 12 weeks. Furthermore, an electrophysiological study was performed at 6 weeks postoperatively to measure the mental nerve's amplitude, onset latency and conduction velocity
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
- Double (Participant, Care Provider)
盲法说明
Sequentially numbered, opaque, sealed envelopes (SNOSE) allocation concealment method will be utilized. Each participant included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each participant is allocated and placed inside opaque envelopes carrying the respective names of participants. A trial independent personnel will be assigned the role of keeping the envelopes and unfolding them only at the time of the operation, so that the participant is allocated to a group which is concealed from the operator
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from recent, uninfected and minimally displaced or unfavorable fractures at parasymphysis-body region of the mandible
- •Adult patients from 20-40 years old with no gender predilection that agreed to present for follow-up visits for a minimum postoperative period of 3 months.
- •A fracture that demands open reduction and internal fixation.
- •The patient medically fit for general anesthesia.
排除标准
- •Medically compromised patients contradicting operation.
- •Pathological fracture.
- •An old fracture.
- •Completely edentulous patient.
- •Patients with frank infection.
- •Patients with a comminuted fracture.
研究组 & 干预措施
Patients with mandibular fracture in the anterior transition zone managed with Twinfork plate
Patients with mandibular fracture in the anterior transition zone managed with Twinfork plate
干预措施: Twinfork plate (Device)
Patients with mandibular fracture in the anterior transition zone managed with 3D-interlocking
Patients with mandibular fracture in the anterior transition zone managed with 3D-interlocking plate
干预措施: 3D-interlocking plate (Device)
Patients with mandibular fracture in the anterior transition zone managed with miniplates
Patients with mandibular fracture in the anterior transition zone managed with miniplates
干预措施: Miniplate (Device)
结局指标
主要结局
Sensory nerve function
时间窗: 6 weeks
Objective assessment by using a dental probe pressure to determine any sensory changes along the distribution of the mental nerve in comparison to the contralateral side (nociceptive method).
次要结局
- Radiographic evaluation for fracture healing(3 months)