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

Maxilla; Hypoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03511989
• Other study ID #: N-20160057
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: August 1, 2025

Study information

• Verified date: January 2020
• Source: Aalborg University Hospital
• Contact: Tue L Blæhr, DDS
• Email: t.blaehr[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Previous orthognathic surgery involving the maxilla Congenital maxillofacial deformities

Related Conditions & MeSH terms

• Maxilla; Hypoplasia

Intervention

Device:
• Bone borne distractor
Bone borne distraction device
• Tooth borne distractor
Tooth borne distraction device

Procedure:
• Segmental LF1 Osteotomy group 1

• Segmental LF1 Osteotomy group 2

• Segmental LF1 Osteotomy group 3

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal relapse	Relapse in milimeters	2 years
Secondary	Dental relapse	Relapse in milimeters	2 years