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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 20, 2014