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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Jaw Abnormalities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No