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

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.

Study Overview

• Status: Recruiting
• Conditions: Maxilla; Hypoplasia
• Intervention / Treatment: Device: Bone borne distractor; Device: Tooth borne distractor; Procedure: Segmental LF1 Osteotomy group 1; Procedure: Segmental LF1 Osteotomy group 3; Procedure: Segmental LF1 Osteotomy group 2

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tue L Blæhr, DDS; Email: t.blaehr@rn.dk
• Study Contact Backup: Name: Thomas Starch-jensen, DDS

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Aalborg University Hospital
    • Contact: Tue L Blæhr, DDS; Email: t.blaehr@rn.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal relapse	Relapse in milimeters	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental relapse	Relapse in milimeters	2 years

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Principal Investigator: Tue Blæhr, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): April 30, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: N-20160057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No