The Effect of Splint Usage in Laterognathic Cl III Orthognathic Surgery Patients: Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- MPI Records for Splint Users
研究概览
简要总结
It is crucial to maintain the anatomic condylar positions during orthognathic surgery. Condylar positions are affected directly under general anesthesia because of joint and muscle relaxation. Possible unwanted changes in the joint position may cause incorrect positioning of the jawbones. This could affect the success of the surgery in terms of function and facial aesthetics causing the need for a second surgery. Our aim is to evaluate whether the use of MR Splint has a statistically significant effect on muscle relaxation-induced condyle position deviations under general anesthesia in Class III Laterognathia patients.
详细描述
It is crucial to maintain the anatomic condyle positions during orthognathic surgery to prevent iatrogenic temporomandibular joint complications. Condyle shunts are affected directly under general anesthesia because of the joint and muscle relaxation. Surgical guidance appliances are prepared according to the TMJ records taken chairside while patients are in an upright position. During surgery, these appliances are applied in a supine position while the muscles are relaxed. Postoperative and long-term effects of TMJ and muscle relaxation obtained under general anesthesia in class III and asymmetric patients will be examined. Patients who had occlusal splint before records taken will be evaluated in terms of condyle location by MPI.
Our aim is to evaluate whether the use of MR Splint has a statistically significant effect on muscle relaxation-induced condyle position deviations under general anesthesia in Class III Laterognathia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Although it will be explained to the patients that they would be included in a study determining the joint positions and that a bite record would be taken from them during the operation for this purpose, they will not informed about whether they are included in the splint treatment group or the control group.
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
- •being ready for orthognathic surgery
- •must be able to give centric relation records
排除标准
- •having any TMDsyndromes
- •cleft lip and palate,
- •have bruxism,
- •TMJ or muscle disfunctions,
- •under any medication of muscle relaxants,
- •narcotics and antidepressants,
- •usage of removeable prosthetics
- •have toothless areas that can affect the wax impression for centric record
- •used horizontal elastics within the last 2 months
结局指标
主要结局
MPI Records for Splint Users
时间窗: 12 months
Difference between preoperative and intraoperative condylar positions will be observed as mm with bite records. MPI will be used in the lab to determine the difference.
次要结局
未报告次要终点
研究者
Banu Kılıç
Assistant Professor
Bezmialem Vakif University