A Modified Minimally Invasive Approach Towards Le Fort I Osteotomy: a Prospective Study (MILF-I)

January 15, 2021 updated by: Gwen Swennen, AZ Sint-Jan AV

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruges, Belgium
        • General Hospital Saint-John Bruges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consenting patients requiring a bimaxillary orthognathic procedure as part of their orthodontic-surgical treatment plan, and satisfying the inclusion and exclusion criteria.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
accuracy of the minimally invasive approach in comparison to conventional approaches, based on 3D virtual CBCT superimposition of planning CBCT and postoperative CBCT
Time Frame: at 4 weeks postoperative
at 4 weeks postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Surgical time necessary to complete the procedure
Time Frame: perioperative
perioperative
Intraoperative and early postoperative complications
Time Frame: within 4 weeks postoperative
within 4 weeks postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AZ Sint-Jan AV

Investigators

  • Principal Investigator: Gwen Swennen, Division of Maxillofacial Surgery, Department of Surgery, General Hospital Saint-John Bruges, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 18, 2016

First Posted (ESTIMATE)

January 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO49201525495

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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