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

NCT03511989 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-01-09

No results posted yet for this study

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.

Conditions

  • Maxilla; Hypoplasia

Interventions

DEVICE

Bone borne distractor

Bone borne distraction device

DEVICE

Tooth borne distractor

Tooth borne distraction device

PROCEDURE

Segmental LF1 Osteotomy group 1

PROCEDURE

Segmental LF1 Osteotomy group 2

PROCEDURE

Segmental LF1 Osteotomy group 3

Sponsors & Collaborators

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Tue Blæhr · Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2023-08-01
Completion
2025-08-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03511989 on ClinicalTrials.gov