Clinical trial NCT02660216: A Modified Minimally Invasive Approach Towards Le Fort I Osteotomy: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Jaw Abnormalities
Keywords: minimally invasive
le fort I osteotomy
3D virtual treatment planning
accuracy
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: accuracy of the minimally invasive approach in comparison to conventional approaches, based on 3D virtual CBCT superimposition of planning CBCT and postoperative CBCT
timeFrame: at 4 weeks postoperative
Secondary outcomes:
measure: Surgical time necessary to complete the procedure
timeFrame: perioperative
measure: Intraoperative and early postoperative complications
timeFrame: within 4 weeks postoperative
Other outcomes:
Locations:
city: Bruges
country: Belgium
facility: general hospital Saint-John Bruges
Study officials:
affiliation: Division of Maxillofacial Surgery, Department of Surgery, General Hospital Saint-John Bruges, Belgium
name: Gwen Swennen
role: PRINCIPAL_INVESTIGATOR
References: