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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03511989
Enrollment
90
Registered
2018-04-30
Start date
2016-08-01
Completion date
2025-08-01
Last updated
2020-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxilla; Hypoplasia

Brief 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.

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.

Interventions

PROCEDURESegmental LF1 Osteotomy group 1
PROCEDURESegmental LF1 Osteotomy group 2
PROCEDURESegmental LF1 Osteotomy group 3
DEVICEBone borne distractor

Bone borne distraction device

DEVICETooth borne distractor

Tooth borne distraction device

Sponsors

Aalborg University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Previous orthognathic surgery involving the maxilla Congenital maxillofacial deformities

Design outcomes

Primary

MeasureTime frameDescription
Skeletal relapse2 yearsRelapse in milimeters

Secondary

MeasureTime frameDescription
Dental relapse2 yearsRelapse in milimeters

Countries

Denmark

Contacts

Primary ContactTue L Blæhr, DDS
t.blaehr@rn.dk
Backup ContactThomas Starch-jensen, DDS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026