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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Maxilla; Hypoplasia

Intervention / Treatment
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* Device: Bone borne distractor
* Device: Tooth borne distractor
* Procedure: Segmental LF1 Osteotomy group 1
* Procedure: Segmental LF1 Osteotomy group 2
* Procedure: Segmental LF1 Osteotomy group 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mature non-syndromic patients scheduled for transverse expansion of the maxilla Exclusion Criteria: Previous orthognathic surgery involving the maxilla Congenital maxillofacial deformities

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |