Clinical Trials Directory

Trials / Completed

CompletedNCT02660216

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

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
AZ Sint-Jan AV · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2014-11-01
Primary completion
2019-12-01
Completion
2019-12-01
First posted
2016-01-21
Last updated
2021-01-19

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT02660216. Inclusion in this directory is not an endorsement.