A Modified Minimally Invasive Approach Towards Le Fort I Osteotomy: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- accuracy of the minimally invasive approach in comparison to conventional approaches, based on 3D virtual CBCT superimposition of planning CBCT and postoperative CBCT
研究概览
简要总结
Nowadays, maxillary Le Fort I osteotomy is a safe and routinely performed procedure. The conventional approach is characterized by a vestibular incision extending from molar-to-molar, associated with a pterygomaxillary disjunction performed with a curved chisel. Adequate mobilization of the maxilla during Le Fort I osteotomy requires an effective separation of the maxillary tuberosity from the pterygoid plates of the sphenoid bone. However, as initially described by Precious (1991) and later by Hernandez-Alfaro (2013), a true pterygomaxillary osteotomy is not necessary to achieve successful disjunction. Furthermore, Hernandez-Alfaro combined his technique of pterygomaxillary disjunction, the so-called "Twist technique", to a minimally invasive protocol, performing the complete Le Fort I osteotomy through a 20 to 30 mm long horizontal vestibular incision. Although promising, the technique remains highly sensitive from a technical standpoint, and its true accuracy has not been comprehensively evaluated.
The purpose of this study is to present and validate a minimally invasive approach towards Le Fort I osteotomy, using a modified pterygomaxillary (PTM) disjunction technique. The primary outcome is to evaluate the accuracy of the technique using rigid voxel-based registration of the 3D virtual treatment planning and the 4 weeks postoperative CBCT images. Secondary outcomes include the surgical time necessary to complete the procedure and the presence of intraoperative and early postoperative complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of all ages
- •Patients of all genders
- •A Le Fort I osteotomy is planned, as part of a bimaxillary orthognathic procedure
- •The surgery is planned with 3D Virtual Treatment Planning (Maxilim v. 2.3.0.3.0.)
- •The planning is transferred with 3D CAD/CAM tooth-borne splint and vertical internal bony reference landmarks
- •The maxilla is repositioned first during the surgery (maxilla first sequence)
排除标准
- •Patients not eligible according to abovementioned criteria
- •Simultaneous extraction of impacted teeth 18 and/or 28
- •Previous maxillary orthognathic surgery
- •Previous Surgical Assisted Rapid Palatal Expansion (SARPE)
- •Syndromic condition, including cleft lip and palate
- •Segmental Le Fort I osteotomy
- •Adjuvant Zygomatic osteotomy
- •Maxillary impaction higher than 3 mm
- •Maxillary advancement greater than 5 mm
结局指标
主要结局
accuracy of the minimally invasive approach in comparison to conventional approaches, based on 3D virtual CBCT superimposition of planning CBCT and postoperative CBCT
时间窗: at 4 weeks postoperative
次要结局
- Surgical time necessary to complete the procedure(perioperative)
- Intraoperative and early postoperative complications(within 4 weeks postoperative)
研究者
Gwen Swennen
Maxillofacial Surgeon, MD, LDS, DMD, PhD, FEBOMFS
AZ Sint-Jan AV
