Effectiveness of SARPE With 3 and 2-Segment Technique: A Randomized Clinical Trial
NCT ID: NCT02179593
Last Updated: 2016-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2013-09-30
2016-12-31
Brief Summary
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Detailed Description
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The participants will be assigned randomizable in equal number to undergo either 3-segment or 2-segment SARPE.
Individuals that a) have undergone maxilla surgery previously; b) have craniofacial anomaly;and c) have dental crowding will not be enrolled.
All participants will be assessed before and after surgery for sensitivity to pressure and temperature in the innervated structures linked to the maxilla, as well as for quality of life using OHIP-49 and B-OQLQ assessment tools.
The expansion of maxilla will be assessed by superimposing tomographic images before and after surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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2-Segment SARPE
Maxilla expansion using one sagittal section of the maxilla.
2-Segment SARPE
Le Fort I osteotomy with oppening of the median palatal suture and SARPE.
3-Segment SARPE
Maxilla Expansion using two parasagittal section of the maxilla.
3-Segment SARPE
Le Fort I osteotomy with two parallel osteotomies symetrically positioned with reference to the median palatal suture and SARPE.
Interventions
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2-Segment SARPE
Le Fort I osteotomy with oppening of the median palatal suture and SARPE.
3-Segment SARPE
Le Fort I osteotomy with two parallel osteotomies symetrically positioned with reference to the median palatal suture and SARPE.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having 7-millimeter transverse maxilla deficiency bilaterally distributed.
Exclusion Criteria
* Having craniofacial anomaly
* Having excessive dental crowding.
17 Years
50 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Max Domingues Pereira
MD, PhD
Principal Investigators
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Max D Pereira, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Gabriela PR Prado, MS
Role: STUDY_CHAIR
Federal University of São Paulo
Fabianne MG Furtado, PhD
Role: STUDY_CHAIR
Federal University of São Paulo
Lydia M Ferreira, PhD
Role: STUDY_CHAIR
Federal University of São Paulo
Locations
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Federal University of Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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464.869
Identifier Type: -
Identifier Source: org_study_id
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