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

NCT02660216 | Completed

• 1 other identifier: BO49201525495
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Jaw Abnormalities

Keywords

minimally invasive; le fort I osteotomy; 3D virtual treatment planning; accuracy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Surgical time necessary to complete the procedure

  perioperative

• Intraoperative and early postoperative complications

  within 4 weeks postoperative

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

general hospital Saint-John Bruges

Bruges, Belgium

Location

MeSH Terms

Conditions

Jaw Abnormalities

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Gwen Swennen

  Division of Maxillofacial Surgery, Department of Surgery, General Hospital Saint-John Bruges, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maxillofacial Surgeon, MD, LDS, DMD, PhD, FEBOMFS

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 21, 2016
• Study Start: November 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)