Stability of Bilateral Sagittal Split Ramus Osteotomy (BSSRO) Using Adjustable Mandibular Plates in Adjunction With Bicortical Screws Versus Traditional Positional Screws for Antero-posterior Mandibular Deficient Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- cephalometric analysis to measure angles(degrees)
研究概览
简要总结
In this current study a comparison between 3 positional screws versus the adjustable plating system in conjunction with 2 positional screws. The patients will be selected to have retrognathic mandible requiring advancement. Hypothetically the advantage of the adjustable plating system will be compared with the three positional screws. In theory, the investigators will be using the inherent advantage of the intraoperative flexibility of the adjustable plating system in verifying the position of the proximal segment (condylar segment), hence eliminating the immediate postoperative relapse that is reported with using three positional screws. This will be evaluated both clinically and cephalometrically.
详细描述
Trauner and Obwegeser in 1957, reported the first correction of jaw deformity by the sagittal split technique.
Dal Pont in 1961, a student of Obwegeser, made a modification to the latter technique, to further enhance the precision and the accuracy of movement of both proximal distal segments his technique has become widely publicized. He changed the lower horizontal cut to a vertical cut on the buccal cortex between the first and second molars, there by obtaining broader bony contact.
Hunsuck in 1968, modified the technique, to decrease the soft tissue dissection; he advocated a shorter horizontal medial cut.
Epker in 1977, modified the technique in several ways to decrease swelling, manipulation to the neurovascular bundle and hemorrhage, his modification included minimal stripping of the masseter muscle and medial dissection.
BSSRO is now the most common procedure used to advance the mandible is a bilateral sagittal split osteotomy.
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, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients suffering from mandibular retrognathia (anteroposterior deficient mandible)
- •Patients should be free from any systemic disease that may affect normal healing, and predictable outcome
排除标准
- •Patients with any systemic disease that may affect normal healing
- •Intra-bony lesions or infections that may retard the osteotomy healing
- •Uncooperative Patient with bad oral hygiene
研究组 & 干预措施
3 bicortical screw
1st group:3 bicortical screws will be used to fix the sagittal split ramus osteotomy.
干预措施: 3 bicortical screws (Device)
adjustable plate and 2 bicortical screws
adjustable plate and 2 bicortical screws will be used to fix the sagittal split ramus osteotomy.
干预措施: adjustable plate and 2 bicortical screws (Device)
结局指标
主要结局
cephalometric analysis to measure angles(degrees)
时间窗: (an xray preoperative, immediate postoperative, 6 weeks and 6 months)
cephalometric analysis to measure lines(mm)
时间窗: (an xray preoperative, immediate postoperative, 6 weeks and 6 months)
次要结局
- operation time in minutes(intraoperative timing during surgery)
研究者
Joseph Van Sickels
Principal Investigator
University of Kentucky