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

Aalborg University Hospital

Status: Enrolling

Conditions: Maxilla; Hypoplasia

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

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

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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 2

Procedure: Segmental LF1 Osteotomy group 1