Maxillary expansion techniques for treating hypoplasia
Transverse Maxillary Expansion With a Segmental Le Fort I Osteotomy or Surgically Assisted Rapid Maxillary Expansion (SARME)
This study is testing different surgical methods to see which ones work best for helping people with maxillary hypoplasia expand their upper jaw.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 1 site (Aalborg) |
| Trial ID | NCT03511989 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and stability of different surgical techniques for transverse maxillary expansion in patients with maxillary hypoplasia. It compares segmental Le Fort I osteotomy (SLFIO) with various fixation methods, including bone block grafts and biodegradable plates, as well as surgically assisted rapid maxillary expansion (SARME) using different distraction appliances. The study will involve 90 patients who will be randomly assigned to different treatment groups, and outcomes will be assessed through clinical and radiographic measurements.
Who should consider this trial
Good fit: Ideal candidates for this study are mature, non-syndromic patients scheduled for transverse expansion of the maxilla.
Not a fit: Patients who have previously undergone orthognathic surgery involving the maxilla or have congenital maxillofacial deformities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques for maxillary expansion, resulting in better long-term stability and outcomes for patients.
How similar studies have performed: While various surgical techniques for maxillary expansion have been explored, this study systematically compares different fixation methods and distraction appliances, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Mature non-syndromic patients scheduled for transverse expansion of the maxilla Exclusion Criteria: Previous orthognathic surgery involving the maxilla Congenital maxillofacial deformities
Where this trial is running
Aalborg
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
Study contacts
- Principal investigator: Tue Blæhr — Aalborg University Hospital
- Study coordinator: Tue L Blæhr, DDS
- Email: t.blaehr@rn.dk
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.