Transverse Maxillary Expansion With a Segmental Le Fort I Osteotomy or Surgically Assisted Rapid Maxillary Expansion (SARME)

Not Applicable

Recruiting

• Conditions: Maxilla; Hypoplasia
• Interventions: Procedure: Segmental LF1 Osteotomy group 1; Device: Bone borne distractor; Device: Tooth borne distractor; Procedure: Segmental LF1 Osteotomy group 2; Procedure: Segmental LF1 Osteotomy group 3

• Registration Number: NCT03511989
• Lead Sponsor: Aalborg University Hospital

Brief Summary

To assess transverse dental and skeletal expansion and stability after SLFIO with no fixation of the palatal vault compared to stabilization of the palatal vault with an autogenous bone block graft or fixation of the palatal osteotomy site with a biodegradable plate.

To assess transverse maxillary dental and skeletal expansion and stability after SARME with a TB distraction appliance compared to a BB distraction appliance.

Detailed Description

Background: Surgical correction of transverse maxillary hypoplasia, in adolescents and adults is considered the least stable orthognathic procedure. Different surgical techniques have been advocated to improve the transverse stability. However, the pattern of transverse dental and skeletal expansion and long-term stability after segmental Le Fort I osteotomy (SLFIO) and surgically assisted rapid maxillary expansion (SARME) have never been compared systematically with different fixation techniques or distraction appliances.

Purpose: Test the H0-hypothesis of no difference in transverse stability after SLFIO without fixation of the palatal vault compared to stabilizing with either a bone block graft or a biodegradable plate. Moreover, test the H0-hypothesis of no difference in transverse maxillary dental and skeletal expansion and stability after SARME with either a tooth-borne (TB) or a bone-borne (BB) distraction appliance.

Method: 60 patients scheduled for SLFIO are included in a randomized clinical trial and allocated into 3 groups; I) stabilization of the palatal vault with a bone block graft, II) fixation of the palatal vault with a biodegradable plate and III) no fixation of the palatal vault. Moreover, 30 patients undergoing SARME are randomly allocated to either a TB or a BB distraction appliance. Transverse expansion and stability is assessed by clinical and radiographic measurements evaluating differences between dental and skeletal expansion, the pattern of skeletal expansion and the long-term stability.

Primary impact goal: Long-term transverse maxillary stability after SLFIO and SARME.

Study Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2018-04-27
• Study First Posted: 2018-04-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-09
• Primary Completion: 2023-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Mature non-syndromic patients scheduled for transverse expansion of the maxilla

Exclusion Criteria

Previous orthognathic surgery involving the maxilla Congenital maxillofacial deformities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Segmental LF1 osteotomy group 3	Segmental LF1 Osteotomy group 2	Testgroup, autologous bonegraft at palatal osteotomy site
Segmental LF1 osteotomy group 2	Segmental LF1 Osteotomy group 3	Testgroup, biodegradable plate at osteotomy site in palate
Segmental LF1 osteotomy group 3	Segmental LF1 Osteotomy group 1	Testgroup, autologous bonegraft at palatal osteotomy site
Segmental LF1 osteotomy group 2	Segmental LF1 Osteotomy group 1	Testgroup, biodegradable plate at osteotomy site in palate
Bone Borne distractor	Bone borne distractor	The device being investigated, Boneborne distraction appliance
Tooth borne distractor	Tooth borne distractor	The control device Toothborne distraction appliance

Primary Outcome Measures

Name	Time	Method
Skeletal relapse	2 years	Relapse in milimeters

Secondary Outcome Measures

Name	Time	Method
Dental relapse	2 years	Relapse in milimeters

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark