Accuracy of Waferless One Stage Segmental Lefort I Maxillary Positioning in Transverse Deficiency Using CAD/CAM Patient Specific Titanium Implants (Case Series Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 6
- 主要终点
- Transverse dimension of maxilla on virtual plan and postoperative
研究概览
简要总结
In Maxillary transverse deficiency, is waverless lefort I multiple pieces osteotomy using virtually planned patient specific titanium implants feasible and does it provide accuracy?
This prospective case series study evaluating the postoperative outcomes and accuracy of preoperatively planned positional changes together with virtually designed drilling and fixation guides for the waferless positioning and fixation of the multiple pieces Le Fort I of the maxilla using CAD-CAM designed patient-specific implants.
The purpose of this study is to develop and validate an orthognathic CAD/CAM patient specific implant together with template that can guide both the osteotomy and the repositioning of the maxilla during the correction of transverse maxillary deficiency.
Thus, the traditional model and the additional preparation for CAD/CAM surgical splints including scanning dental casts, and recording and moving virtual dental casts, were not required. The preoperative and laboratory procedures were simplified, and the intermediate splint technique was eliminated, so the associated potential errors were avoided.
详细描述
The aim of this study is to evaluate the accuracy of planned waferless positioning of lefort I multiple piece osteotomy in maxillary deficient patients using CAD-CAM patient-specific implants together with virtually designed drilling and fixation guides.
Interventions
- Diagnostic procedures:
All Patients will be selected according to inclusion and exclusion criteria & Comprehensive clinical examination and understanding of patients' chief complains and needs will be carried out Preoperative patient photographs (Frontal, Profile, 45°, smile, and dental occlusion) Alginate Impressions† of upper & lower jaws for acquiring diagnostic dental casts Cone Beam Computed Topography (CBCT) for the patients § 2. Planning procedures:
Computer-aided planning: All planning will be done using specialized Mimics software** Import CBCT into virtual planning software. Segmentation: highlighting and selection of the bony anatomy based on bone density (Hounsfield Units).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients suffering from transverse and anteroposterior maxillary discrepancy.
- •Patients requiring bimaxillary orthognathic surgery.
- •Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- •Patients who will agree to the consent and will commit to follow-up period.
- •Highly motivated patients.
排除标准
- •Patients who are younger than 14 years.
- •Patients having a significant systemic disease that may affect normal healing.
- •Intra-bony lesions or infections that may retard the osteotomy healing.
- •Patients receiving chemo or radiotherapy.
- •Known allergies or sensitivities to dental materials, including Titanium or general anesthesia agents.
- •Patient with bad oral hygiene.
- •Pregnant females.
- •Inability to return for follow up visits.
- •Refusal of participation from the patient.
研究组 & 干预措施
Segmental maxillary lefort I re-positioning
Accuracy of the planned virtually re-positioned segmental Lefort I maxilla using a specifically designed patient implant, comparing the virtual plan to the actual postoperative position.
干预措施: Accuracy of planned transverse Maxillary distance using Mimics software after fixation using Patient specific implant (Procedure)
结局指标
主要结局
Transverse dimension of maxilla on virtual plan and postoperative
时间窗: 1-3 months
8 Reference points will be chosen below the osteotomy line on the maxilla (4 dental and 4 bony), and the distances between these points and the Frankfort, the midfacial, and the coronal planes, to show the vertical, horizontal, and axial positions of the maxilla, respectively. These distances will be measured on the postoperative CT data and their deviations from the virtual plan will illustrate the accuracy of our procedure. The 4 bony reference points are : PF: Piriform at the widest point ; J: The junction between the maxillary tuberosity outline and the zygomatic process (63); and GPF: Greater palatine foramen. The 4 dental reference points are: A3L: Cusp of the left maxillary canine; A3R: Cusp of the right maxillary canine; A6L: Mesiobuccal cusp of the left first maxillary molar; and A6R: Mesiobuccal cusp of the right first maxillary molar.
次要结局
- Planning & surgical times: estimated time to the actual time(1-3 months)
研究者
Rasha Anwar Ibrahim Taman
Assistant Lecturer
Cairo University