Accuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 14
- 主要终点
- Accuracy of movement of surgical segments in millimeter
研究概览
简要总结
In patient with skeletal open bite, Dose computer-aided surgery enhances the clinical outcomes and accuracy versus conventional model surgery
详细描述
P Adult Patients with skeletal open bite.
I Computer guided surgery.
C Conventional articulating model surgery
O Outcome measure:
Outcome Name Measuring Device Measuring Unit (mm)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 skeletal open bite caused by vertical posterior maxillary excess and/or short mandible ramus.
- •Patients should be free from any systemic disease that may affect normal healing, and predictable outcome.
- •Required two jaws orthographic surgery
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.
- •Patient with bad oral hygiene.
- •Uncontrolled Diabetes mellitus.
研究组 & 干预措施
Conventional Model Surgery
Lateral Cephalogram with analysis and tracing of facial profile.
Modified model surgical tecnique:
- Obtain wax bite registration.
- Record face-bow transfer.
- Duplication of articulating model for surgical simulation.
- Measure all casts and bases in standard model surgery fashion.
- Fabricate intermediate splint & Final splint.
- Condylar repositional splint.
干预措施: Conventional model surgery (Procedure)
Conventional Model Surgery
Lateral Cephalogram with analysis and tracing of facial profile.
Modified model surgical tecnique:
- Obtain wax bite registration.
- Record face-bow transfer.
- Duplication of articulating model for surgical simulation.
- Measure all casts and bases in standard model surgery fashion.
- Fabricate intermediate splint & Final splint.
- Condylar repositional splint.
干预措施: 2D cephalometric radiograph (Device)
Computer guided surgery
Preoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan.
Computer-aided planning for study group:
All planning will be done using specialized software (Anatomage Invivo 5.3) for preoperative surgical simulation and immediate postoperative evaluation.
Pre-operative Fabrication of computer aided surgical splint:
In the study group a stereo splint will be fabricated using rapid prototyping (RP) technique to guide the osteotomy and another one will be fabricated after virtual osteotomy to guide the surgical cuts. And stent for guided holes.
So that the osteotomy will be accomplished by the aid of computer guided templates that simulates the proper bite achieved preoperatively during surgical simulation and Planning.
干预措施: Computer guided surgery (Procedure)
Computer guided surgery
Preoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan.
Computer-aided planning for study group:
All planning will be done using specialized software (Anatomage Invivo 5.3) for preoperative surgical simulation and immediate postoperative evaluation.
Pre-operative Fabrication of computer aided surgical splint:
In the study group a stereo splint will be fabricated using rapid prototyping (RP) technique to guide the osteotomy and another one will be fabricated after virtual osteotomy to guide the surgical cuts. And stent for guided holes.
So that the osteotomy will be accomplished by the aid of computer guided templates that simulates the proper bite achieved preoperatively during surgical simulation and Planning.
干预措施: 3D computerized tomography (Device)
结局指标
主要结局
Accuracy of movement of surgical segments in millimeter
时间窗: up to 4 months
Computer guided Super-imposition of virtual surgery over the post- operative CT Scan composite models (millimeter mm). Conventional Super-imposition of scanned articulator with mounted casts in the pre-planned mock surgery over post-operative scanned mounted occlusion- accuracy would be compared by difference between Intervention and control in (millimeter mm).
次要结局
- Anterior open Bite Closure (positive overbite in millimeter)(up to 4 months)
研究者
Ammar Ribhi Abu shama
PHD Doctor in Oral and Maxillofacial Surgery
Cairo University