Effectiveness of SARPE With 3 and 2-Segment Technique: A Randomized Clinical Trial (3S/2S_SARPE)

March 14, 2016 updated by: Max Domingues Pereira, Federal University of São Paulo

Effectiveness of Surgically Assisted Rapid Palatal Expansion (SARPE) With 3 and 2-Segment Technique: A Randomized Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

32 healthy, literate adult patients (male and female) with 7-millimeter transverse maxilla deficiency bilaterally distributed will participate in this study.

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04024002
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 2-Segment SARPE
Maxilla expansion using one sagittal section of the maxilla.
Other: 2-Segment SARPE
Le Fort I osteotomy with oppening of the median palatal suture and SARPE.
Other Names:
  • Surgically Assisted Rapid Maxillary Expansion (SARME)
  • Surgically Assisted Rapid Palatal Expansion (SARPE)
Other: 3-Segment SARPE
Maxilla Expansion using two parasagittal section of the maxilla.
Other: 3-Segment SARPE
Le Fort I osteotomy with two parallel osteotomies symetrically positioned with reference to the median palatal suture and SARPE.
Other Names:
  • Surgically Assisted Rapid Palatal Expansion (SARPE)
  • Surgically Assisted Rapid MaxillaryExpansion (SARME)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: An average of 2 weeks after expansion.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maxillary symmetry
Time Frame: pre-operative and an average of 2 weeks at the end of maxillary expansion.
The maxillary symmetry will be assessed by analyzing before and after 3D imaging obtained from computed tomography data , superimposed using the Geomagic Qualify software.
pre-operative and an average of 2 weeks at the end of maxillary expansion.
Stability of dental and osseous structures
Time Frame: pre-operative, an average of 2 weeks at the end of the expansion, 4 months, 1 and 2 years after maxillary expansion.
The stability of dental and osseous structures will be analyzed using computer-aided 3D analysis of data obtained through the scanning of dental casts using Bicam 3D scanner (Scaierman - Italy).
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
Time Frame: pre-operative,an average of 2 weeks at the end of the expansion, 4 and 12 months after maxillary expansion.
The nasal and paranasal topographic changes will be captured using laser scanner device.
pre-operative,an average of 2 weeks at the end of the expansion, 4 and 12 months after maxillary expansion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Max D Pereira, Phd, Federal University of São Paulo
  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 29, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimate)

July 2, 2014

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 464.869

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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