Digitally Fabricated Inter-occlusal Wafer Versus Wafer-less Distal Segment Repositioning for Bilateral Sagittal Split Osteotomy in Skeletal Mandibular Deformities (Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Postop occlusal translational discrepancy (T6):
研究概览
简要总结
Research studies continues to attempt testing modifications to refine the treatment protocols through computer assisted design or computer-generated surgical Wafer splints, have greatly revolutionized the incorporation of digital imaging and 3D design in Orthognathic surgery.
Integrating computer guided technology in orthognathic surgery aims to to simplify workup and reduce surgical errors, eliminate occlusal discrepancy, increase the realignment accuracy of the distal segments according to the preoperative plan. Implementing a waferless technique raised the question of efficiency versus the use of occlusal wafers and whether it has a significant measurable effect on the surgical outcome and objectives.
Rationale for conducting this study is to assess the difference between the effect of computer guided waferless technique and computer guided technique with occlusal wafer on accuracy of postoperative occlusion and condylar position.
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详细描述
The use of waferless orthognathic surgery technique raised the question of efficiency versus the use of occlusal wafers and whether it has a significant measurable effect on the surgical outcome and objectives.
Modification and attempts to refine the treatment protocols through computer assisted design or computer-generated surgical Wafer splints, have greatly revolutionized the incorporation of digital imaging and 3D design in Orthognathic surgery. Combining the knowledge acquired from later studies with the advancement in 3D design software and increased resolution of imaging, waferless orthognathic computer guided protocols have been explored and investigating a more accurate technique is now being competitively pursued. The objective of this study is to evaluate the accuracy of the 3D printed positioning device to reposition the Distal segments according to the preoperative virtual plan after BSSO versus final digitally fabricated interocclusal wafer with distal extension for correction of class II or III mandibular deformities.
Trial design:
Randomized controlled trial
From the selected eligible patient population, candidates will be randomly allocated into 2 groups:
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in need of bilateral sagittal split osteotomy for mandibular repositioning.
- •All patients are free from any systemic disease that may affect normal bone healing.
- •Sufficient dentition to reproduce the occlusal relationships
- •Patient's consent to participate
排除标准
- •Patients with any systemic disease that may affect normal healing
- •Intra-bony lesions or infections that may interfere with surgery.
- •Previous orthognathic surgeries.
结局指标
主要结局
Postop occlusal translational discrepancy (T6):
时间窗: Outcomes will be assessed with immediate postoperative CT at T4 (week 27).
measured in mm from sagittal, axial, and coronal postop CT images. Measuring error and deviation of postoperative bony segments to the preoperative virtual plan.
Postop occlusal translational discrepancy (T3):
时间窗: Outcomes will be assessed with immediate postoperative CT at T3 (week 3).
measured in mm from sagittal, axial, and coronal postop CT images. Measuring error and deviation of postoperative bony segments to the preoperative virtual plan.
Postop occlusion rotation and deviation (T3):
时间窗: Outcomes will be assessed with immediate postoperative CT at T3 (week 3).
measured in degrees from 3D objects preoperative 3D cephalometric landmarks. comparing postoperative occlusal plane rotational deviation in reference to preoperative planned occlusion.
Postop occlusion rotation and deviation (T27):
时间窗: Outcomes will be assessed with immediate postoperative CT at T4 (week 27).
measured in degrees from 3D objects preoperative 3D cephalometric landmarks. comparing postoperative occlusal plane rotational deviation in reference to preoperative planned occlusion.
3D spatial deviation error (T3):
时间窗: Outcomes will be assessed with immediate postoperative CT at T3 (week 3).
Absolute point to point 3D measurements in the 3D virtual environment of the postop 3D bony segments in reference to the preop objects.
3D spatial deviation error (T27):
时间窗: Outcomes will be assessed with immediate postoperative CT at T4 (week 27).
Absolute point to point 3D measurements in the 3D virtual environment of the postop 3D bony segments in reference to the preop objects.
次要结局
- Operative Time(immediate postop.)
- Relapse over time:(at week 27, after 6 weeks)
研究者
Hesham O. Morsi
Assistant Lecturer
Cairo University