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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
André Barbisan de Souza, DDS, State University of Maringá
ClinicalTrials.gov Identifier:
NCT01765062
First received: December 20, 2012
Last updated: January 8, 2013
Last verified: January 2013
  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 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 20, 2012
Last Updated: January 8, 2013
Health Authority: Brazil: Sistema NAcional de Ética em Pesquisa (SISNEP)

Keywords provided by State University of Maringá:
Rapid maxillary expansion
Cross bite
Haas appliance
Lateral cephalograms

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 23, 2014