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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01765062
First Posted: January 10, 2013
Last Update Posted: January 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
André Barbisan de Souza, DDS, State University of Maringá
  Purpose
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.

Condition
Cross-bite

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: One Year Skeletal and Dental Arch Changes Following Rapid Maxillary Expansion Treatment in Children

Further study details as provided by André Barbisan de Souza, DDS, State University of Maringá:

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

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

Enrollment: 14
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Before Rapid Maxillary Expansion
T0
3 months After Rapid Maxillary Expansion
T1
One year After Rapid Maxillary Expansion
T2

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Sample
Criteria

Inclusion Criteria:

  • cross-bite with maxillary atresia

Exclusion Criteria:

  • patients had undergone orthodontic treatment or had a syndrome
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765062


Locations
Brazil
Universidade Estadual de Maringa
Maringa, Parana, Brazil
Sponsors and Collaborators
State University of Maringá
Investigators
Principal Investigator: Daniela G Garib, PHD Universidade de São Paulo-USP-Faculdade de Odontologia de Bauru
  More Information

Responsible Party: André Barbisan de Souza, DDS, Kelly Regina Micheletti, DDS, State University of Maringá
ClinicalTrials.gov Identifier: NCT01765062     History of Changes
Other Study ID Numbers: KRM-300585
First Submitted: December 20, 2012
First Posted: January 10, 2013
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by André Barbisan de Souza, DDS, State University of Maringá:
Rapid maxillary expansion
Cross bite
Haas appliance
Lateral cephalograms

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases