Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02660216
Study type Observational
Source AZ Sint-Jan AV
Contact
Status Completed
Phase
Start date November 2014
Completion date December 2019

See also
  Status Clinical Trial Phase
Completed NCT02658305 - Transoral Versus Transbuccal Placement of Bicortical Screws During Orthognathic Surgery N/A
Recruiting NCT05151042 - Digital Occlusal Wafer Versus Waferless Distal Segment Repositioning for BSSO in Skeletal Mandibular Deformities N/A
Recruiting NCT02595307 - Improving Informed Consent for Cleft Palate Repair N/A
Recruiting NCT02660021 - Prospective Registry of 3-dimensional Virtual Treatment Planning of Orthognathic Surgery