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

A

Aalborg University Hospital

Status

Enrolling

Conditions

Maxilla; Hypoplasia

Treatments

Procedure: Segmental LF1 Osteotomy group 2
Procedure: Segmental LF1 Osteotomy group 1
Device: Tooth borne distractor
Device: Bone borne distractor
Procedure: Segmental LF1 Osteotomy group 3

Study type

Interventional

Funder types

Other

Identifiers

NCT03511989
N-20160057

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

15+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Previous orthognathic surgery involving the maxilla Congenital maxillofacial deformities

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 5 patient groups

Bone Borne distractor
Active Comparator group
Description:
The device being investigated, Boneborne distraction appliance
Treatment:
Device: Bone borne distractor
Tooth borne distractor
Other group
Description:
The control device Toothborne distraction appliance
Treatment:
Device: Tooth borne distractor
Segmental LF1 osteotomy group 1
No Intervention group
Description:
Control Group, no stabilization of palatal vault
Segmental LF1 osteotomy group 2
Active Comparator group
Description:
Testgroup, biodegradable plate at osteotomy site in palate
Treatment:
Procedure: Segmental LF1 Osteotomy group 3
Procedure: Segmental LF1 Osteotomy group 1
Segmental LF1 osteotomy group 3
Active Comparator group
Description:
Testgroup, autologous bonegraft at palatal osteotomy site
Treatment:
Procedure: Segmental LF1 Osteotomy group 1
Procedure: Segmental LF1 Osteotomy group 2

Trial contacts and locations

1

Loading...

Central trial contact

Thomas Starch-jensen, DDS; Tue L Blæhr, DDS

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems