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临床试验/NCT02660216
NCT02660216已完成不适用

A Modified Minimally Invasive Approach Towards Le Fort I Osteotomy: a Prospective Study

AZ Sint-Jan AV1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年11月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gwen Swennen

Maxillofacial Surgeon, MD, LDS, DMD, PhD, FEBOMFS

AZ Sint-Jan AV

研究点 (1)

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