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

Jaw Abnormalities Clinical Trial

— MILF-I  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660216
• Other study ID #: BO49201525495
• Status: Completed
• Start date: November 2014
• Est. completion date: December 2019

Study information

• Verified date: January 2021
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Jaw Abnormalities

Locations

Country	Name	City	State
Belgium	general hospital Saint-John Bruges	Bruges

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of the minimally invasive approach in comparison to conventional approaches, based on 3D virtual CBCT superimposition of planning CBCT and postoperative CBCT		at 4 weeks postoperative
Secondary	Surgical time necessary to complete the procedure		perioperative
Secondary	Intraoperative and early postoperative complications		within 4 weeks postoperative