One Year Skeletal and Dental Arch Changes Following Rapid Maxillary Expansion Treatment in Children (ERM)

January 8, 2013 updated by: André Barbisan de Souza, DDS, State University of Maringá
Many author have exposed the rapid and slow expansion, the diversity of activation and containment protocols and the follow-up time, justify the need for more studies to evaluate the effects to the ERM for the long-term.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

14

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
    • Parana
      • Maringa, Parana, Brazil
        • Universidade Estadual de Maringá

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

5 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community Sample

Description

Inclusion Criteria:

  • cross-bite with maxillary atresia

Exclusion Criteria:

  • patients had undergone orthodontic treatment or had a syndrome

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

Cohorts and Interventions

Group / Cohort
Before Rapid Maxillary Expansion
T0
3 months After Rapid Maxillary Expansion
T1
One year After Rapid Maxillary Expansion
T2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in cephalometric variables
Time Frame: prior to rapid maxillary expansion (T0), after three months (T1) and after one year
prior to rapid maxillary expansion (T0), after three months (T1) and after one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Dental casts
Time Frame: prior to rapid maxillary expansion (T0), after three months (T1) and after one year (T2).
prior to rapid maxillary expansion (T0), after three months (T1) and after one year (T2).

Collaborators and Investigators

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

Sponsor

State University of Maringá

Investigators

  • Principal Investigator: Daniela G Garib, PHD, Universidade de São Paulo-USP-Faculdade de Odontologia de Bauru

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

July 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 10, 2013

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRM-300585

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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