NCT02179593

Brief Summary

A few studies state that 3-segment SARPE has the following advantages: a) higher level of expansion symmetry; b) higher level of stability of the expansion achieved; and c) faster bone healing. The investigators hypothesize that 2-segment SARPE is as effective as 3-segment SARPE concerning treatment and/or quality of life in daily practice.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

June 29, 2014

Last Update Submit

March 14, 2016

Conditions

Maxillary Hypoplasia

Keywords

Maxillary expansionOrthognathic surgerySymmetryPalatal expansion techniqueMaxilla abnormality

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    The primary outcome chosen in this study is Quality of Life assessed through the Orthognathic Quality of Life Questionaire (OQLQ) and Oral Health Impact Profile (OHIP-49) currently available in Portuguese language and validated for scientific studies.

    An average of 2 weeks after expansion.

Secondary Outcomes (3)

  • Maxillary symmetry

    pre-operative and an average of 2 weeks at the end of maxillary expansion.

  • Stability of dental and osseous structures

    pre-operative, an average of 2 weeks at the end of the expansion, 4 months, 1 and 2 years after maxillary expansion.

  • Nasal and paranasal topographic changes

    pre-operative,an average of 2 weeks at the end of the expansion, 4 and 12 months after maxillary expansion.

Study Arms (2)

2-Segment SARPE

OTHER

Maxilla expansion using one sagittal section of the maxilla.

Other: 2-Segment SARPE

3-Segment SARPE

OTHER

Maxilla Expansion using two parasagittal section of the maxilla.

Other: 3-Segment SARPE

Interventions

2-Segment SARPEOTHER

Le Fort I osteotomy with oppening of the median palatal suture and SARPE.

Also known as: Surgically Assisted Rapid Maxillary Expansion (SARME), Surgically Assisted Rapid Palatal Expansion (SARPE)
2-Segment SARPE
3-Segment SARPEOTHER

Le Fort I osteotomy with two parallel osteotomies symetrically positioned with reference to the median palatal suture and SARPE.

Also known as: Surgically Assisted Rapid Palatal Expansion (SARPE), Surgically Assisted Rapid MaxillaryExpansion (SARME)
3-Segment SARPE

Eligibility Criteria

Age17 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being healthy and literate
  • Having 7-millimeter transverse maxilla deficiency bilaterally distributed.

You may not qualify if:

  • Having undergone maxilla surgery previously
  • Having craniofacial anomaly
  • Having excessive dental crowding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04024002, Brazil

Location

MeSH Terms

Conditions

Retrognathia

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMandibular DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Max D Pereira, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Gabriela PR Prado, MS

    Federal University of São Paulo

    STUDY CHAIR

  • Fabianne MG Furtado, PhD

    Federal University of São Paulo

    STUDY CHAIR

  • Lydia M Ferreira, PhD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 29, 2014

First Posted

July 2, 2014

Study Start

September 1, 2013

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

BR(1)